Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Inotuzumab Ozogamicina e quimioterapia de primeira linha no tratamento de adultos jovens com leucemia linfoblástica aguda B recém-diagnosticada

2 de novembro de 2026 atualizado por: Alliance for Clinical Trials in Oncology

Um estudo de fase III para avaliar a eficácia da adição de Inotuzumabe Ozogamicina (um anticorpo monoclonal anti-CD22 conjugado) à terapia de primeira linha em adultos jovens (de 18 a 39 anos) com células B precursoras recém-diagnosticadas

This phase III trial studies the side effects of inotuzumab ozogamicin and how well it works when given with frontline chemotherapy in treating patients with newly diagnosed B acute lymphoblastic leukemia. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Chemotherapy drugs, such as [intervention], work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may work better in treating young adults with B acute lymphoblastic leukemia.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

PRIMARY OBJECTIVES:

I. To confirm tolerability of the combination regimen with the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of cancer and leukemia group B (CALGB) 10403.

II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, without censoring for transplant. (Phase III) III. To determine the safety and tolerability of a reduced dose of inotuzumab ozogamicin and two cycles of blinatumomab added to the pediatric-inspired regimen of CALGB 10403 (Pilor cohort).

SECONDARY OBJECTIVES:

I. To determine the impact of inotuzumab ozogamicin on disease-free (DFS) and overall survival (OS) in patients who achieve an induction response.

II. To determine whether the addition of inotuzumab ozogamicin significantly improves the event-free survival (EFS) in patients who achieve an induction response achieved with the pediatric-inspired regimen of CALGB 10403, with censoring for transplant.

III. To determine the impact of inotuzumab ozogamicin on minimal residual disease (MRD) and correlate this with the EFS, DFS and OS.

IV. To determine the prognosis based on patients' low-density array (LDA) gene signature in terms of EFS, DFS, and OS after treatment with or without inotuzumab ozogamicin when added to the C10403 backbone regimen.

V. To evaluate the toxicity and tolerability of the addition of inotuzumab ozogamicin to the pediatric-inspired regimen of CALGB 10403.

CORRELATIVE SCIENCE OBJECTIVES:

I. To assess both the correlation of MRD post-induction and at sequential timepoints with LDA signature.

II. To evaluate the influence of MRD status (detectable vs. not and as a continuous measure) in relation to EFS both in the univariate setting as well as adjusting for other clinical features including initial white blood cell (WBC), ethnicity, sex and age at diagnosis.

III. To evaluate the impact of inotuzumab ozogamicin (inotuzumab) on the kinetics of MRD during treatment with inotuzumab in patients randomized to the experimental treatment arm.

IV. To perform genomic analyses to identify and evaluate the incidence and clinical significance of recurring novel fusion genes including those associated with the BCR-ABL1-like signature and to correlate with MRD status, CR rate, EFS and OS.

V. To assess whether rs4958351 is correlated with L-asp allergic reaction in the adolescent and young adult (AYA) population.

VI. To assess the incidence of inherited genetic variants in the GR1A1, CEP72, CPA2, TPMT, NUDT15, GRIN3A, GRIK1, and other genes (which can be found using a whole genome association study [GWAS]), are correlated with increased rates of target toxicities including peripheral neuropathy, hepatotoxicity, pancreatitis, myelosuppression, neurotoxicity, thrombosis, and osteonecrosis, and correlate with treatment discontinuation and other clinical response parameters including complete response (CR) rate, EFS, and OS.

VII. To evaluate asparaginase pharmacokinetics in adolescents and young adults, and investigate its correlation with toxicities and treatment outcomes.

VIII. To investigate the effect of anti-polyethylene glycol (PEG) and anti-agouti signaling protein (ASP) antibodies (PEG-ASP) on ASP enzyme activity.

IX. To measure adherence to oral 6 mercaptopurine (MP) and methotrexate in AYAs with acute lymphoblastic leukemia (ALL) and to examine sociodemographic and behavioral determinants of adherence.

X. To determine the impact of adherence on risk of relapse among AYAs with ALL. XI. To correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters.

XII. To correlate specific karyotype groups with response rates, response duration, survival, and cure in patients treated on this protocol.

XIII. To correlate specific karyotype groups with MRD. XIV. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse.

XV. To define the rate, analytical performance, and diagnostic yield of ChromoSeq vs. conventional G-banded karyotyping and fluorescence in situ hybridization (FISH) for B ALL patients in a multicenter setting.

OUTLINE:

COURSE I (REMISSION INDUCTION THERAPY): All patients receive allopurinol orally (PO) once daily until peripheral blasts and extramedullary disease are reduced and cytarabine intrathecally (IT) over 1 minute on day 1. Patients also receive daunorubicin hydrochloride intravenously, over 1 to 30 minutes (IV) and vincristine sulfate IV on days 1, 8, 15 and 22, dexamethasone PO or IV twice daily (BID) on days 1-7 and 15-21, pegaspargase for patients >21.5 years IV, over 1 to 2 hours on day 4, 5, or 6, or calaspargase pegol IV, over 1 hour, on days 4, 5 or 6 and methotrexate IT over 1 minute on days 8 and 29. Patients with central nervous system (CNS) 3 disease receive methotrexate IT over 1 minute also on days 15 and 22. All patients then undergo bone marrow aspirate and biopsy on day 29.

Patients enrolled prior to Update 8 with response to remission induction therapy are randomized to 1 of 2 arms. Patients enrolled after amendment 8 are assigned to the pilot cohort. Patients with no response are omitted from the study.

ARM I (CLOSED 7/23/2025):

COURSE II (REMISSION CONSOLIDATION CHEMOTHERAPY): Patients receive cyclophosphamide IV on days 1 and 29, cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, and vincristine sulfate IV, over 1 to 10 minutes on days 15, 22, 43, and 50. Patients >21.5 years also receive pegaspargase IV, over 1 to 2 hours, on days 15 and 43 and patients <21.5 years old receive calaspargase pegol IV, over 1 hour, on days 2 and 22, and methotrexate IT on days 1, 8, 15, and 22. Patients with CNS3 receive methotrexate IT only on days 1 and 8. CD20 positive (+) patients receive rituximab IV on days 1, 8, 29, and 36. Patients with evidence of testicular disease at diagnosis also receive radiation therapy (RT). Patients who are MRD+ and CD19+ after completion of this course receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo bone marrow aspirate and biopsy on day 56.

COURSE III (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 11, 21, 31, and 41, methotrexate IV, over 24 hours, and IT on days 1, 11, 21, 31, and 41, patients >21.5 years old receive pegaspargase IV, over 1 to 2 hours, and patients < 21.5 years old receive calaspargase pegol IV, over 1 hour on days 2 and 22. CD20+ patients receive rituximab IV on days 1 and 11.

COURSE IV (DELAYED INTENSIFICATION): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1-7 and 15-21, doxorubicin IV, over 3 to 60 minutes, on days 1, 8, and 15, patients >21.5 years old receive pegaspargase IV, over 1 to 2 hours, on day 4, 5, or 6 and day 43, patients <21.5 years old receive calaspargase pegol IV, over 1 hour, on days 2 and 22. Patients also receive cyclophosphamide IV on day 29, cytarabine IV or SC on days 29-32 and 36-39, thioguanine PO on days 29-42 and methotrexate IT on days 1, 29, and 36. CD20+ patients receive rituximab IV on days 1 and 8. Patients then undergo bone marrow aspirate and biopsy one week after completion of course IV.

COURSE V (MAINTENANCE THERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 29, and 57, dexamethasone PO or IV BID on days 1-5, 29-33, and 57-61, and mercaptopurine PO on days 1-84. Patients also receive methotrexate IT or PO on days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78. Treatment repeats every 12 weeks for up to 3 years in the absence of disease progression or unacceptable toxicity.

Patients undergo multigated acquisition scan (MUGA) or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study.

ARM II (CLOSED 7/23/2025): Patients receive inotuzumab ozogamicin IV, over 1 hour, on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who are MRD+ and CD19+ after completion of 2 cycles of inotuzumab ozogamicin receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I.

Patients undergo MUGA or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study.

PILOT COHORT: Patients receive inotuzumab ozogamicin IV, over 1 hour, on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28.

COURSE II (REMISSION CONSOLIDATION CHEMOTHERAPY): Patients receive cyclophosphamide IV on days 1 and 29, cytarabine IV or SC on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14 and 29-42, and vincristine sulfate IV, over 1 to 10 minutes, on days 15, 22, 43, and 50. Patients > 21.5 years old also receive pegaspargase IV, over 1 to 2 hours, on days 15 and 43 and patients < 21.5 years old receive calaspargase pegol IV, over 1 hour, on days 15 and 43, and methotrexate IT on days 1, 8, 15, and 22. Patients with CNS3 receive methotrexate IT only on days 1 and 8. CD20+ patients receive rituximab IV on days 1, 8, 29, and 36. Patients with evidence of testicular disease at diagnosis also receive RT. Patients then undergo bone marrow aspirate and biopsy on day 56.

BLINATUMOMAB: Patients receive blinatumomab IV, continuously, on days 1-28 of one 42-day cycle in the absence of disease progression or unacceptable toxicity. Patients also receive dexamethasone PO or IV prior to starting the blinatumomab cycle, and a single dose of methotrexate IT between cycle days 29 and 42.

COURSE III (INTERIM MAINTENANCE CHEMOTHERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes, on days 1, 11, 21, 31, and 41, methotrexate IV, over 24 hours, and IT on days 1, 11, 21, 31, and 41, patients >21.5 years old receive pegaspargase IV, over 1 to 2 hours, and patients < 21.5 years old receive calaspargase pegol IV, over 1 hour on days 2 and 22. CD20+ patients receive rituximab IV on days 1 and 11.

BLINATUMOMAB: Patients receive blinatumomab IV, continuously, on days 1-28 of one 42-day cycle in the absence of disease progression or unacceptable toxicity. Patients also receive dexamethasone PO or IV prior to starting the blinatumomab cycle, and a single dose of methotrexate IT between cycle days 29 and 42. Patients who are MRD positive and CD19+ after Course II may continue to receive blinatumomab IV, continuously on days 1-28 of each cycle. Cycles repeat every 42 days for an additional 2 cycles in the absence of disease progression or unacceptable toxicity, per investigator discretion.

COURSE IV (DELAYED INTENSIFICATION): Patients receive vincristine sulfate IV, over 1 to 10 minutes on days 1, 8, 15, 43, and 50, dexamethasone PO or IV BID on days 1-7 and 15-21, doxorubicin IV, over 3 to 60 minutes, on days 1, 8, and 15, patients > 21.5 years old receive pegaspargase IV, over 1 to 2 hours, on day 4, 5, or 6 and day 43, patients < 21.5 years old receive calaspargase pegol IV, over 1 hour, on day 4, 5, or 6 and 43. Patients also receive cyclophosphamide IV on day 29, cytarabine IV or SC on days 29-32 and 36-39, thioguanine PO on days 29-42 and methotrexate IT on days 1, 29, and 36. CD20+ patients receive rituximab IV on days 1 and 8. Patients then undergo bone marrow aspirate and biopsy one week after completion of course IV.

COURSE V (MAINTENANCE THERAPY): Patients receive vincristine sulfate IV, over 1 to 10 minutes on days 1, 29, and 57, dexamethasone PO or IV BID on days 1-5, 29-33, and 57-61, and mercaptopurine PO on days 1-84. Patients also receive methotrexate IT on day 1 of cycles 1-4 and PO once weekly (QW) of each cycle. Treatment repeats every 12 weeks for up to 3 years in the absence of disease progression or unacceptable toxicity.

Patients undergo MUGA or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study.

After completion of study treatment, patients are followed up every 2 months for 2 years, every 3 months 2 years, and then every 6 months for up to 10 years.

Tipo de estudo

Intervencional

Inscrição (Estimado)

303

Estágio

  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Canadá
    • Alberta
      • Calgary, Alberta, Canadá, T2N 5G2
        • Suspenso
        • Arthur J E Child Comprehensive Cancer Centre
    • Manitoba
      • Winnipeg, Manitoba, Canadá, R3E 0V9
        • Suspenso
        • CancerCare Manitoba
    • Nova Scotia
      • Halifax, Nova Scotia, Canadá, B3H 2Y9
        • Recrutamento
        • QEII Health Sciences Centre/Nova Scotia Health Authority
        • Contato:
          • Site Public Contact
          • Número de telefone: 902-473-6000
        • Investigador principal:
          • Nicholas A. Forward
    • Ontario
      • Ottawa, Ontario, Canadá, K1H 8L6
        • Recrutamento
        • Ottawa Hospital and Cancer Center-General Campus
        • Contato:
          • Site Public Contact
          • Número de telefone: 613-761-4395
        • Investigador principal:
          • Jill Fulcher
    • Quebec
      • Montreal, Quebec, Canadá, H3T 1E2
        • Suspenso
        • Jewish General Hospital
  • Estados Unidos
    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35233
        • Ativo, não recrutando
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, Estados Unidos, 98508
        • Suspenso
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Estados Unidos, 99504
        • Suspenso
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, Estados Unidos, 99508
        • Suspenso
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Estados Unidos, 99508
        • Suspenso
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Estados Unidos, 99508
        • Suspenso
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Estados Unidos, 99508
        • Suspenso
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Estados Unidos, 99508
        • Suspenso
        • Katmai Oncology Group
      • Anchorage, Alaska, Estados Unidos, 99508
        • Suspenso
        • Providence Alaska Medical Center
      • Fairbanks, Alaska, Estados Unidos, 99701
        • Suspenso
        • Fairbanks Memorial Hospital
    • Arizona
      • Kingman, Arizona, Estados Unidos, 86401
        • Suspenso
        • Kingman Regional Medical Center
      • Phoenix, Arizona, Estados Unidos, 85054
        • Suspenso
        • Mayo Clinic Hospital in Arizona
      • Scottsdale, Arizona, Estados Unidos, 85259
        • Retirado
        • Mayo Clinic in Arizona
    • Arkansas
      • Fort Smith, Arkansas, Estados Unidos, 72903
        • Suspenso
        • Mercy Hospital Fort Smith
    • California
      • Antioch, California, Estados Unidos, 94531
        • Recrutamento
        • Kaiser Permanente-Deer Valley Medical Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Arroyo Grande, California, Estados Unidos, 93420
        • Suspenso
        • PCR Oncology
      • Burbank, California, Estados Unidos, 91505
        • Suspenso
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Clovis, California, Estados Unidos, 93611
        • Recrutamento
        • Community Cancer Institute
        • Investigador principal:
          • Mohammed S. Bukari
        • Contato:
          • Site Public Contact
          • Número de telefone: 559-387-1827
      • Clovis, California, Estados Unidos, 93611
        • Suspenso
        • University Oncology Associates
      • Costa Mesa, California, Estados Unidos, 92627
        • Recrutamento
        • UC Irvine Health Cancer Center-Newport
        • Investigador principal:
          • Deepa Jeyakumar
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-827-8839
      • Dublin, California, Estados Unidos, 94568
        • Recrutamento
        • Kaiser Permanente Dublin
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
        • Investigador principal:
          • Jennifer M. Suga
      • Fremont, California, Estados Unidos, 94538
        • Recrutamento
        • Kaiser Permanente-Fremont
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Fresno, California, Estados Unidos, 93720
        • Recrutamento
        • Kaiser Permanente-Fresno
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Fresno, California, Estados Unidos, 93720
        • Suspenso
        • Fresno Cancer Center
      • Fresno, California, Estados Unidos, 93720
        • Recrutamento
        • Kaiser Permanente Fresno Orchard Plaza
        • Investigador principal:
          • Jennifer M. Suga
        • Contato:
          • Site Public Contact
          • Número de telefone: 833-574-2273
      • Irvine, California, Estados Unidos, 92612
        • Recrutamento
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Investigador principal:
          • Deepa Jeyakumar
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-827-8839
          • E-mail: ucstudy@uci.edu
      • Modesto, California, Estados Unidos, 95356
        • Recrutamento
        • Kaiser Permanente-Modesto
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Modesto, California, Estados Unidos, 95356
        • Recrutamento
        • Kaiser Permanente- Modesto MOB II
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
        • Investigador principal:
          • Jennifer M. Suga
      • Oakland, California, Estados Unidos, 94611
        • Recrutamento
        • Kaiser Permanente-Oakland
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Oakland, California, Estados Unidos, 94611
        • Suspenso
        • Kaiser Permanente Oakland-Broadway
      • Orange, California, Estados Unidos, 92868
        • Recrutamento
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Investigador principal:
          • Deepa Jeyakumar
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-827-8839
          • E-mail: ucstudy@uci.edu
      • Palo Alto, California, Estados Unidos, 94304
        • Recrutamento
        • Stanford Cancer Institute Palo Alto
        • Investigador principal:
          • Michaela Liedtke
        • Contato:
      • Rancho Cordova, California, Estados Unidos, 95670
        • Suspenso
        • Kaiser Permanente-Rancho Cordova Cancer Center
      • Redwood City, California, Estados Unidos, 94063
        • Suspenso
        • Kaiser Permanente-Redwood City
      • Redwood City, California, Estados Unidos, 94063
        • Suspenso
        • Kaiser Permanente- Marshall Medical Offices
      • Richmond, California, Estados Unidos, 94801
        • Recrutamento
        • Kaiser Permanente-Richmond
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Rohnert Park, California, Estados Unidos, 94928
        • Suspenso
        • Rohnert Park Cancer Center
      • Roseville, California, Estados Unidos, 95661
        • Recrutamento
        • Kaiser Permanente-Roseville
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Roseville, California, Estados Unidos, 95678
        • Suspenso
        • The Permanente Medical Group-Roseville Radiation Oncology
      • Sacramento, California, Estados Unidos, 95817
        • Recrutamento
        • University of California Davis Comprehensive Cancer Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 916-734-3089
        • Investigador principal:
          • Brian A. Jonas
      • Sacramento, California, Estados Unidos, 95814
        • Recrutamento
        • Kaiser Permanente Downtown Commons
        • Investigador principal:
          • Jennifer M. Suga
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: kpoct@kp.org
      • Sacramento, California, Estados Unidos, 95823
        • Recrutamento
        • Kaiser Permanente-South Sacramento
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Sacramento, California, Estados Unidos, 95823
        • Suspenso
        • South Sacramento Cancer Center
      • Sacramento, California, Estados Unidos, 95825
        • Suspenso
        • Kaiser Permanente Sacramento Medical Center
      • San Francisco, California, Estados Unidos, 94115
        • Recrutamento
        • Kaiser Permanente-San Francisco
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • San Jose, California, Estados Unidos, 95119
        • Recrutamento
        • Kaiser Permanente-Santa Teresa-San Jose
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • San Leandro, California, Estados Unidos, 94577
        • Recrutamento
        • Kaiser Permanente San Leandro
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • San Rafael, California, Estados Unidos, 94903
        • Recrutamento
        • Kaiser San Rafael-Gallinas
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • San Rafael, California, Estados Unidos, 94903
        • Suspenso
        • Kaiser Permanente-San Rafael
      • Santa Clara, California, Estados Unidos, 95051
        • Recrutamento
        • Kaiser Permanente Medical Center - Santa Clara
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Santa Rosa, California, Estados Unidos, 95403
        • Recrutamento
        • Kaiser Permanente-Santa Rosa
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • South San Francisco, California, Estados Unidos, 94080
        • Suspenso
        • Kaiser Permanente Cancer Treatment Center
      • South San Francisco, California, Estados Unidos, 94080
        • Recrutamento
        • Kaiser Permanente-South San Francisco
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Stockton, California, Estados Unidos, 95210
        • Recrutamento
        • Kaiser Permanente-Stockton
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Vacaville, California, Estados Unidos, 95688
        • Recrutamento
        • Kaiser Permanente Medical Center-Vacaville
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Vallejo, California, Estados Unidos, 94589
        • Recrutamento
        • Kaiser Permanente-Vallejo
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
      • Walnut Creek, California, Estados Unidos, 94596
        • Recrutamento
        • Kaiser Permanente-Walnut Creek
        • Contato:
          • Site Public Contact
          • Número de telefone: 877-642-4691
          • E-mail: Kpoct@kp.org
        • Investigador principal:
          • Jennifer M. Suga
    • Colorado
      • Aurora, Colorado, Estados Unidos, 80012
        • Suspenso
        • The Medical Center of Aurora
      • Aurora, Colorado, Estados Unidos, 80012
        • Ativo, não recrutando
        • Rocky Mountain Cancer Centers-Aurora
      • Boulder, Colorado, Estados Unidos, 80303
        • Ativo, não recrutando
        • Boulder Community Foothills Hospital
      • Boulder, Colorado, Estados Unidos, 80304
        • Ativo, não recrutando
        • Rocky Mountain Cancer Centers-Boulder
      • Centennial, Colorado, Estados Unidos, 80112
        • Ativo, não recrutando
        • Rocky Mountain Cancer Centers - Centennial
      • Denver, Colorado, Estados Unidos, 80220
        • Suspenso
        • Rose Medical Center
      • Denver, Colorado, Estados Unidos, 80204
        • Suspenso
        • Cancer Center of Colorado at Sloan's Lake
      • Denver, Colorado, Estados Unidos, 80206
        • Suspenso
        • National Jewish Health-Main Campus
      • Denver, Colorado, Estados Unidos, 80218
        • Ativo, não recrutando
        • Presbyterian - Saint Lukes Medical Center - Health One
      • Denver, Colorado, Estados Unidos, 80209
        • Ativo, não recrutando
        • The Women's Imaging Center
      • Denver, Colorado, Estados Unidos, 80218
        • Ativo, não recrutando
        • Colorado Blood Cancer Institute
      • Denver, Colorado, Estados Unidos, 80218
        • Ativo, não recrutando
        • Rocky Mountain Cancer Centers-Midtown
      • Denver, Colorado, Estados Unidos, 80220
        • Ativo, não recrutando
        • Rocky Mountain Cancer Centers-Rose
      • Denver, Colorado, Estados Unidos, 80220
        • Ativo, não recrutando
        • Western Surgical Care
      • Denver, Colorado, Estados Unidos, 80218
        • Suspenso
        • Saint Joseph Hospital - Cancer Centers of Colorado
      • Englewood, Colorado, Estados Unidos, 80113
        • Suspenso
        • Swedish Medical Center
      • Englewood, Colorado, Estados Unidos, 80113
        • Ativo, não recrutando
        • Mountain Blue Cancer Care Center - Swedish
      • Englewood, Colorado, Estados Unidos, 80113
        • Ativo, não recrutando
        • Rocky Mountain Cancer Centers - Swedish
      • Englewood, Colorado, Estados Unidos, 80113
        • Ativo, não recrutando
        • The Melanoma and Skin Cancer Institute
      • Golden, Colorado, Estados Unidos, 80401
        • Suspenso
        • National Jewish Health-Western Hematology Oncology
      • Grand Junction, Colorado, Estados Unidos, 81501
        • Suspenso
        • Saint Mary's Hospital and Regional Medical Center
      • Greeley, Colorado, Estados Unidos, 80631
        • Suspenso
        • Banner North Colorado Medical Center
      • Lafayette, Colorado, Estados Unidos, 80026
        • Suspenso
        • Good Samaritan Hospital - Cancer Centers of Colorado
      • Lakewood, Colorado, Estados Unidos, 80228
        • Ativo, não recrutando
        • Rocky Mountain Cancer Centers-Lakewood
      • Littleton, Colorado, Estados Unidos, 80120
        • Ativo, não recrutando
        • Rocky Mountain Cancer Centers-Littleton
      • Lone Tree, Colorado, Estados Unidos, 80124
        • Suspenso
        • Sky Ridge Medical Center
      • Lone Tree, Colorado, Estados Unidos, 80124
        • Ativo, não recrutando
        • Rocky Mountain Cancer Centers-Sky Ridge
      • Loveland, Colorado, Estados Unidos, 80539
        • Suspenso
        • Banner North Colorado Medical Center - Loveland Campus
      • Thornton, Colorado, Estados Unidos, 80260
        • Suspenso
        • National Jewish Health-Northern Hematology Oncology
      • Thornton, Colorado, Estados Unidos, 80260
        • Ativo, não recrutando
        • Rocky Mountain Cancer Centers-Thornton
      • Wheat Ridge, Colorado, Estados Unidos, 80401
        • Suspenso
        • Intermountain Health Lutheran Hospital
    • Connecticut
      • Hartford, Connecticut, Estados Unidos, 06105
        • Suspenso
        • Smilow Cancer Hospital Care Center at Saint Francis
      • New Haven, Connecticut, Estados Unidos, 06520
        • Recrutamento
        • Yale University
        • Contato:
        • Investigador principal:
          • Lourdes M. Mendez
      • New Haven, Connecticut, Estados Unidos, 06510
        • Suspenso
        • Smilow Cancer Center/Yale-New Haven Hospital
    • Florida
      • Fort Lauderdale, Florida, Estados Unidos, 33308
        • Suspenso
        • Holy Cross Hospital
      • Hollywood, Florida, Estados Unidos, 33021
        • Recrutamento
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 954-265-1847
          • E-mail: OHR@mhs.net
        • Investigador principal:
          • Fernando M. Vargas Madueno
      • Miami, Florida, Estados Unidos, 33176
        • Ativo, não recrutando
        • Miami Cancer Institute
      • Orlando, Florida, Estados Unidos, 32806
        • Recrutamento
        • Orlando Health Cancer Institute
        • Contato:
        • Investigador principal:
          • Jose E. Sarriera
      • Pembroke Pines, Florida, Estados Unidos, 33028
        • Suspenso
        • Memorial Hospital West
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30322
        • Recrutamento
        • Emory University Hospital/Winship Cancer Institute
        • Investigador principal:
          • William G. Blum
        • Contato:
          • Site Public Contact
          • Número de telefone: 404-778-1868
      • Augusta, Georgia, Estados Unidos, 30912
        • Recrutamento
        • Augusta University Medical Center
        • Investigador principal:
          • Vamsi Kota
        • Contato:
    • Hawaii
      • Hilo, Hawaii, Estados Unidos, 96720
        • Suspenso
        • Island Urology-Hilo
      • Honolulu, Hawaii, Estados Unidos, 96826
        • Recrutamento
        • Kapiolani Medical Center for Women and Children
        • Investigador principal:
          • Craig S. Boddy
        • Contato:
          • Site Public Contact
          • Número de telefone: 808-983-6090
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Suspenso
        • Island Urology
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Recrutamento
        • Straub Clinic and Hospital
        • Investigador principal:
          • Craig S. Boddy
        • Contato:
          • Site Public Contact
          • Número de telefone: 808-522-4333
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Suspenso
        • Hawaii Cancer Care Inc - Waterfront Plaza
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Suspenso
        • Queen's Cancer Cenrer - POB I
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Suspenso
        • Queen's Medical Center
      • Honolulu, Hawaii, Estados Unidos, 96813
        • Suspenso
        • University of Hawaii Cancer Center
      • Honolulu, Hawaii, Estados Unidos, 96817
        • Suspenso
        • Hawaii Cancer Care Inc-Liliha
      • Honolulu, Hawaii, Estados Unidos, 96817
        • Suspenso
        • Kuakini Medical Center
      • Honolulu, Hawaii, Estados Unidos, 96817
        • Suspenso
        • Queen's Cancer Center - Kuakini
      • Honolulu, Hawaii, Estados Unidos, 96817
        • Suspenso
        • The Cancer Center of Hawaii-Liliha
      • Honolulu, Hawaii, Estados Unidos, 96819
        • Suspenso
        • Kaiser Permanente Moanalua Medical Center
      • Lihue, Hawaii, Estados Unidos, 96766
        • Suspenso
        • Wilcox Memorial Hospital and Kauai Medical Clinic
      • ‘Aiea, Hawaii, Estados Unidos, 96701
        • Recrutamento
        • Pali Momi Medical Center
        • Investigador principal:
          • Craig S. Boddy
        • Contato:
          • Site Public Contact
          • Número de telefone: 808-486-6000
      • ‘Aiea, Hawaii, Estados Unidos, 96701
        • Suspenso
        • Queen's Cancer Center - Pearlridge
      • ‘Aiea, Hawaii, Estados Unidos, 96701
        • Suspenso
        • The Cancer Center of Hawaii-Pali Momi
      • ‘Aiea, Hawaii, Estados Unidos, 96701
        • Suspenso
        • Hawaii Cancer Care - Westridge
    • Idaho
      • Boise, Idaho, Estados Unidos, 83712
        • Recrutamento
        • Saint Luke's Cancer Institute - Boise
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
      • Boise, Idaho, Estados Unidos, 83706
        • Recrutamento
        • Saint Alphonsus Cancer Care Center-Boise
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Caldwell, Idaho, Estados Unidos, 83605
        • Recrutamento
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Coeur d'Alene, Idaho, Estados Unidos, 83814
        • Recrutamento
        • Kootenai Health - Coeur d'Alene
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Emmett, Idaho, Estados Unidos, 83617
        • Suspenso
        • Walter Knox Memorial Hospital
      • Fruitland, Idaho, Estados Unidos, 83619
        • Recrutamento
        • Saint Luke's Cancer Institute - Fruitland
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
      • Meridian, Idaho, Estados Unidos, 83642
        • Suspenso
        • Idaho Urologic Institute-Meridian
      • Meridian, Idaho, Estados Unidos, 83642
        • Recrutamento
        • Saint Luke's Cancer Institute - Meridian
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
      • Nampa, Idaho, Estados Unidos, 83687
        • Recrutamento
        • Saint Luke's Cancer Institute - Nampa
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
      • Nampa, Idaho, Estados Unidos, 83687
        • Recrutamento
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Post Falls, Idaho, Estados Unidos, 83854
        • Recrutamento
        • Kootenai Clinic Cancer Services - Post Falls
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Sandpoint, Idaho, Estados Unidos, 83864
        • Recrutamento
        • Kootenai Clinic Cancer Services - Sandpoint
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Twin Falls, Idaho, Estados Unidos, 83301
        • Recrutamento
        • Saint Luke's Cancer Institute - Twin Falls
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
    • Illinois
      • Alton, Illinois, Estados Unidos, 62002
        • Suspenso
        • OSF Saint Anthony's Health Center
      • Burr Ridge, Illinois, Estados Unidos, 60527
        • Suspenso
        • Loyola Center for Health at Burr Ridge
      • Chicago, Illinois, Estados Unidos, 60637
        • Recrutamento
        • University of Chicago Comprehensive Cancer Center
        • Investigador principal:
          • Wendy Stock
        • Contato:
      • Chicago, Illinois, Estados Unidos, 60611
        • Recrutamento
        • Northwestern University
        • Investigador principal:
          • Shira N. Dinner
        • Contato:
      • Chicago, Illinois, Estados Unidos, 60612
        • Recrutamento
        • University of Illinois
        • Contato:
          • Site Public Contact
          • Número de telefone: 312-355-3046
        • Investigador principal:
          • John G. Quigley
      • Chicago, Illinois, Estados Unidos, 60612
        • Recrutamento
        • Rush MD Anderson Cancer Center
        • Contato:
        • Investigador principal:
          • Melissa L. Larson
      • Evanston, Illinois, Estados Unidos, 60201
        • Recrutamento
        • NorthShore University HealthSystem-Evanston Hospital
        • Investigador principal:
          • Amy Y. Wang
        • Contato:
          • Site Public Contact
          • Número de telefone: 847-570-2109
      • Glenview, Illinois, Estados Unidos, 60026
        • Recrutamento
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Investigador principal:
          • Amy Y. Wang
        • Contato:
          • Site Public Contact
          • Número de telefone: 847-570-2109
      • Highland Park, Illinois, Estados Unidos, 60035
        • Recrutamento
        • NorthShore University HealthSystem-Highland Park Hospital
        • Investigador principal:
          • Amy Y. Wang
        • Contato:
          • Site Public Contact
          • Número de telefone: 847-570-2109
      • Homer Glen, Illinois, Estados Unidos, 60491
        • Suspenso
        • Loyola Medicine Homer Glen
      • Lake Forest, Illinois, Estados Unidos, 60045
        • Ativo, não recrutando
        • Northwestern Medicine Lake Forest Hospital
      • Lisle, Illinois, Estados Unidos, 60532
        • Suspenso
        • Rush MD Anderson Cancer Center at Rush Lisle
      • Maywood, Illinois, Estados Unidos, 60153
        • Recrutamento
        • Loyola University Medical Center
        • Investigador principal:
          • Patrick A. Hagen
        • Contato:
          • Site Public Contact
          • Número de telefone: 708-226-4357
      • Melrose Park, Illinois, Estados Unidos, 60160
        • Suspenso
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
      • Mount Vernon, Illinois, Estados Unidos, 62864
        • Suspenso
        • SSM Health Good Samaritan
      • New Lenox, Illinois, Estados Unidos, 60451
        • Recrutamento
        • UC Comprehensive Cancer Center at Silver Cross
        • Investigador principal:
          • Wendy Stock
        • Contato:
      • Orland Park, Illinois, Estados Unidos, 60462
        • Recrutamento
        • University of Chicago Medicine-Orland Park
        • Investigador principal:
          • Wendy Stock
        • Contato:
    • Iowa
      • Carroll, Iowa, Estados Unidos, 51401
        • Ativo, não recrutando
        • Saint Anthony Regional Hospital
      • Des Moines, Iowa, Estados Unidos, 50314
        • Ativo, não recrutando
        • Broadlawns Medical Center
      • Des Moines, Iowa, Estados Unidos, 50309
        • Ativo, não recrutando
        • Iowa Methodist Medical Center
      • Des Moines, Iowa, Estados Unidos, 50316
        • Ativo, não recrutando
        • Iowa Lutheran Hospital
      • Des Moines, Iowa, Estados Unidos, 50309
        • Ativo, não recrutando
        • Blank Children's Hospital
      • Des Moines, Iowa, Estados Unidos, 50309
        • Ativo, não recrutando
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
      • Fort Dodge, Iowa, Estados Unidos, 50501
        • Ativo, não recrutando
        • UI Healthcare Mission Cancer and Blood - Fort Dodge
      • Iowa City, Iowa, Estados Unidos, 52242
        • Recrutamento
        • University of Iowa/Holden Comprehensive Cancer Center
        • Investigador principal:
          • Grerk Sutamtewagul
        • Contato:
          • Site Public Contact
          • Número de telefone: 800-237-1225
      • West Des Moines, Iowa, Estados Unidos, 50266-7700
        • Ativo, não recrutando
        • Methodist West Hospital
    • Kansas
      • Garden City, Kansas, Estados Unidos, 67846
        • Suspenso
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, Estados Unidos, 67530
        • Suspenso
        • Central Care Cancer Center - Great Bend
      • Kansas City, Kansas, Estados Unidos, 66160
        • Recrutamento
        • University of Kansas Cancer Center
        • Investigador principal:
          • Kenneth Byrd
        • Contato:
      • Lawrence, Kansas, Estados Unidos, 66044
        • Suspenso
        • Lawrence Memorial Hospital
      • Westwood, Kansas, Estados Unidos, 66205
        • Recrutamento
        • University of Kansas Hospital-Westwood Cancer Center
        • Investigador principal:
          • Kenneth Byrd
        • Contato:
      • Wichita, Kansas, Estados Unidos, 67214
        • Recrutamento
        • Cancer Center of Kansas - Wichita
        • Contato:
        • Investigador principal:
          • Dennis F. Moore
      • Wichita, Kansas, Estados Unidos, 67208
        • Suspenso
        • Cancer Center of Kansas-Wichita Medical Arts Tower
      • Wichita, Kansas, Estados Unidos, 67214
        • Suspenso
        • Ascension Via Christi Hospitals Wichita
      • Wichita, Kansas, Estados Unidos, 67214
        • Suspenso
        • Wesley Medical Center
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40536
        • Recrutamento
        • University of Kentucky/Markey Cancer Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 859-257-3379
        • Investigador principal:
          • Ayman Qasrawi
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70809
        • Ativo, não recrutando
        • Ochsner Health Center-Summa
      • Baton Rouge, Louisiana, Estados Unidos, 70816
        • Ativo, não recrutando
        • Medical Center of Baton Rouge
      • Baton Rouge, Louisiana, Estados Unidos, 70836
        • Ativo, não recrutando
        • Ochsner High Grove
      • New Orleans, Louisiana, Estados Unidos, 70121
        • Ativo, não recrutando
        • Ochsner Medical Center Jefferson
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21201
        • Recrutamento
        • University of Maryland/Greenebaum Cancer Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 800-888-8823
        • Investigador principal:
          • Shella Saint Fleur-Lominy
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02215
        • Suspenso
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, Estados Unidos, 02114
        • Suspenso
        • Massachusetts General Hospital Cancer Center
      • Boston, Massachusetts, Estados Unidos, 02215
        • Suspenso
        • Dana-Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, Estados Unidos, 48106
        • Recrutamento
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Battle Creek, Michigan, Estados Unidos, 49017
        • Suspenso
        • Bronson Battle Creek
      • Brighton, Michigan, Estados Unidos, 48114
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Brighton, Michigan, Estados Unidos, 48114
        • Recrutamento
        • Trinity Health Medical Center - Brighton
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Canton, Michigan, Estados Unidos, 48188
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Canton, Michigan, Estados Unidos, 48188
        • Recrutamento
        • Trinity Health Medical Center - Canton
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Caro, Michigan, Estados Unidos, 48723
        • Suspenso
        • Caro Cancer Center
      • Chelsea, Michigan, Estados Unidos, 48118
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Chelsea, Michigan, Estados Unidos, 48118
      • Clarkston, Michigan, Estados Unidos, 48346
        • Suspenso
        • Hematology Oncology Consultants-Clarkston
      • Clarkston, Michigan, Estados Unidos, 48346
        • Suspenso
        • Newland Medical Associates-Clarkston
      • Detroit, Michigan, Estados Unidos, 48201
        • Recrutamento
        • Wayne State University/Karmanos Cancer Institute
        • Investigador principal:
          • Jay Yang
        • Contato:
      • Detroit, Michigan, Estados Unidos, 48236
        • Suspenso
        • Henry Ford Health Saint John Hospital
      • East China Township, Michigan, Estados Unidos, 48054
        • Suspenso
        • Henry Ford River District Hospital
      • Farmington Hills, Michigan, Estados Unidos, 48334
        • Recrutamento
        • Weisberg Cancer Treatment Center
        • Investigador principal:
          • Jay Yang
        • Contato:
      • Flint, Michigan, Estados Unidos, 48503
        • Recrutamento
        • Genesys Hurley Cancer Institute
        • Contato:
          • Site Public Contact
          • Número de telefone: 810-762-8038
          • E-mail: wstrong@ghci.org
        • Investigador principal:
          • Tareq Al baghdadi
      • Flint, Michigan, Estados Unidos, 48503
        • Recrutamento
        • Hurley Medical Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 810-762-8038
          • E-mail: wstrong@ghci.org
        • Investigador principal:
          • Tareq Al baghdadi
      • Flint, Michigan, Estados Unidos, 48503
        • Suspenso
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Estados Unidos, 48503
        • Recrutamento
        • Cancer Hematology Centers - Flint
        • Contato:
          • Site Public Contact
          • Número de telefone: 810-762-8038
          • E-mail: wstrong@ghci.org
        • Investigador principal:
          • Tareq Al baghdadi
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Recrutamento
        • Trinity Health Grand Rapids Hospital
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Recrutamento
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Contato:
        • Investigador principal:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, Estados Unidos, 49503
        • Suspenso
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
      • Grosse Pointe Woods, Michigan, Estados Unidos, 48236
        • Suspenso
        • Henry Ford Saint John Hospital - Academic
      • Grosse Pointe Woods, Michigan, Estados Unidos, 48236
        • Suspenso
        • Henry Ford Saint John Hospital - Breast
      • Grosse Pointe Woods, Michigan, Estados Unidos, 48236
        • Suspenso
        • Henry Ford Saint John Hospital - Van Elslander
      • Kalamazoo, Michigan, Estados Unidos, 49007
        • Recrutamento
        • Bronson Methodist Hospital
        • Contato:
        • Investigador principal:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, Estados Unidos, 49007
        • Recrutamento
        • West Michigan Cancer Center
        • Contato:
        • Investigador principal:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, Estados Unidos, 49009
        • Recrutamento
        • Beacon Kalamazoo Cancer Center
        • Investigador principal:
          • Kathleen Y. Butler
        • Contato:
          • Site Public Contact
          • Número de telefone: 574-647-7370
      • Kalamazoo, Michigan, Estados Unidos, 49048
        • Suspenso
        • Beacon Kalamazoo
      • Lansing, Michigan, Estados Unidos, 48912
        • Suspenso
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, Estados Unidos, 48154
        • Suspenso
        • Hope Cancer Clinic
      • Livonia, Michigan, Estados Unidos, 48154
        • Recrutamento
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Macomb, Michigan, Estados Unidos, 48044
        • Suspenso
        • Henry Ford Warren Hospital - Breast Macomb
      • Macomb, Michigan, Estados Unidos, 48044
        • Recrutamento
        • Henry Ford Saint John Hospital - Macomb Medical
        • Investigador principal:
          • Tareq Al baghdadi
        • Contato:
      • Marlette, Michigan, Estados Unidos, 48453
        • Suspenso
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Muskegon, Michigan, Estados Unidos, 49444
        • Suspenso
        • Trinity Health Muskegon Hospital
      • Niles, Michigan, Estados Unidos, 49120
        • Recrutamento
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 616-391-1230
        • Investigador principal:
          • Kathleen Y. Butler
      • Norton Shores, Michigan, Estados Unidos, 49444
        • Suspenso
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
      • Pontiac, Michigan, Estados Unidos, 48341
        • Suspenso
        • Hope Cancer Center
      • Pontiac, Michigan, Estados Unidos, 48341
        • Recrutamento
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Pontiac, Michigan, Estados Unidos, 48341
        • Suspenso
        • Michigan Healthcare Professionals Pontiac
      • Pontiac, Michigan, Estados Unidos, 48341
        • Suspenso
        • Trinity Health IHA Medical Group-Alice Gustafson Center
      • Reed City, Michigan, Estados Unidos, 49677
        • Recrutamento
        • Corewell Health Reed City Hospital
        • Contato:
        • Investigador principal:
          • Kathleen Y. Butler
      • Rochester Hills, Michigan, Estados Unidos, 48309
        • Suspenso
        • Henry Ford Rochester Hospital
      • Saginaw, Michigan, Estados Unidos, 48604
        • Suspenso
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, Estados Unidos, 48601
        • Suspenso
        • MyMichigan Medical Center Saginaw
      • Saint Joseph, Michigan, Estados Unidos, 49085
        • Recrutamento
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contato:
        • Investigador principal:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, Estados Unidos, 49085
        • Suspenso
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
      • Sterling Heights, Michigan, Estados Unidos, 48312
        • Suspenso
        • Bhadresh Nayak MD PC-Sterling Heights
      • Tawas City, Michigan, Estados Unidos, 48764
        • Suspenso
        • MyMichigan Medical Center Tawas
      • Traverse City, Michigan, Estados Unidos, 49684
        • Recrutamento
        • Munson Medical Center
        • Contato:
        • Investigador principal:
          • Kathleen Y. Butler
      • Warren, Michigan, Estados Unidos, 48088
        • Suspenso
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, Estados Unidos, 48093
        • Suspenso
        • Macomb Hematology Oncology PC
      • Warren, Michigan, Estados Unidos, 48093
        • Suspenso
        • Henry Ford Madison Heights Hospital - Breast
      • Warren, Michigan, Estados Unidos, 48093
        • Suspenso
        • Henry Ford Health Warren Hospital
      • Warren, Michigan, Estados Unidos, 48093
        • Suspenso
        • Henry Ford Warren Hospital - GLCMS
      • West Branch, Michigan, Estados Unidos, 48661
        • Suspenso
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Wyoming, Michigan, Estados Unidos, 49519
        • Recrutamento
        • University of Michigan Health - West
        • Contato:
        • Investigador principal:
          • Kathleen Y. Butler
      • Ypsilanti, Michigan, Estados Unidos, 48106
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • Recrutamento
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
    • Minnesota
      • Aitkin, Minnesota, Estados Unidos, 56431
        • Suspenso
        • Riverwood Healthcare Center
      • Brainerd, Minnesota, Estados Unidos, 56401
        • Suspenso
        • Essentia Health Saint Joseph's Medical Center
      • Burnsville, Minnesota, Estados Unidos, 55337
        • Suspenso
        • Fairview Ridges Hospital
      • Burnsville, Minnesota, Estados Unidos, 55337
        • Suspenso
        • Minnesota Oncology - Burnsville
      • Cambridge, Minnesota, Estados Unidos, 55008
        • Suspenso
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, Estados Unidos, 55433
        • Suspenso
        • Mercy Hospital
      • Deer River, Minnesota, Estados Unidos, 56636
        • Suspenso
        • Essentia Health - Deer River Clinic
      • Detroit Lakes, Minnesota, Estados Unidos, 56501
        • Suspenso
        • Essentia Health Saint Mary's - Detroit Lakes Clinic
      • Duluth, Minnesota, Estados Unidos, 55805
        • Recrutamento
        • Essentia Health Cancer Center
        • Contato:
        • Investigador principal:
          • Bret E. Friday
      • Duluth, Minnesota, Estados Unidos, 55805
        • Suspenso
        • Essentia Health Saint Mary's Medical Center
      • Duluth, Minnesota, Estados Unidos, 55805
        • Suspenso
        • Miller-Dwan Hospital
      • Edina, Minnesota, Estados Unidos, 55435
        • Suspenso
        • Fairview Southdale Hospital
      • Fergus Falls, Minnesota, Estados Unidos, 56537
        • Suspenso
        • Lake Region Healthcare Corporation-Cancer Care
      • Fosston, Minnesota, Estados Unidos, 56542
        • Suspenso
        • Essentia Health - Fosston
      • Fridley, Minnesota, Estados Unidos, 55432
        • Ativo, não recrutando
        • Unity Hospital
      • Hibbing, Minnesota, Estados Unidos, 55746
        • Suspenso
        • Essentia Health Hibbing Clinic
      • Maple Grove, Minnesota, Estados Unidos, 55369
        • Suspenso
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, Estados Unidos, 55109
        • Suspenso
        • Minnesota Oncology Hematology PA-Maplewood
      • Maplewood, Minnesota, Estados Unidos, 55109
        • Suspenso
        • Saint John's Hospital - Healtheast
      • Minneapolis, Minnesota, Estados Unidos, 55407
        • Recrutamento
        • Abbott-Northwestern Hospital
        • Contato:
        • Investigador principal:
          • Yan Ji
      • Minneapolis, Minnesota, Estados Unidos, 55415
        • Suspenso
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, Estados Unidos, 55454
        • Suspenso
        • Health Partners Inc
      • Monticello, Minnesota, Estados Unidos, 55362
        • Suspenso
        • Monticello Cancer Center
      • New Ulm, Minnesota, Estados Unidos, 56073
        • Suspenso
        • New Ulm Medical Center
      • Park Rapids, Minnesota, Estados Unidos, 56470
        • Suspenso
        • Essentia Health - Park Rapids
      • Princeton, Minnesota, Estados Unidos, 55371
        • Suspenso
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, Estados Unidos, 55422
        • Suspenso
        • North Memorial Medical Health Center
      • Rochester, Minnesota, Estados Unidos, 55905
        • Recrutamento
        • Mayo Clinic in Rochester
        • Contato:
          • Site Public Contact
          • Número de telefone: 855-776-0015
        • Investigador principal:
          • Aasiya Matin
      • Saint Louis Park, Minnesota, Estados Unidos, 55416
        • Suspenso
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, Estados Unidos, 55102
        • Suspenso
        • United Hospital
      • Saint Paul, Minnesota, Estados Unidos, 55101
        • Suspenso
        • Regions Hospital
      • Sandstone, Minnesota, Estados Unidos, 55072
        • Suspenso
        • Essentia Health Sandstone
      • Shakopee, Minnesota, Estados Unidos, 55379
        • Suspenso
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, Estados Unidos, 55082
        • Suspenso
        • Lakeview Hospital
      • Virginia, Minnesota, Estados Unidos, 55792
        • Suspenso
        • Essentia Health Virginia Clinic
      • Waconia, Minnesota, Estados Unidos, 55387
        • Suspenso
        • Ridgeview Medical Center
      • Willmar, Minnesota, Estados Unidos, 56201
        • Suspenso
        • Rice Memorial Hospital
      • Woodbury, Minnesota, Estados Unidos, 55125
        • Suspenso
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, Estados Unidos, 55092
        • Suspenso
        • Fairview Lakes Medical Center
    • Missouri
      • Ballwin, Missouri, Estados Unidos, 63011
        • Suspenso
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, Estados Unidos, 65613
        • Suspenso
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, Estados Unidos, 65616
        • Suspenso
        • Cox Cancer Center Branson
      • City of Saint Peters, Missouri, Estados Unidos, 63376
        • Recrutamento
        • Siteman Cancer Center at Saint Peters Hospital
        • Investigador principal:
          • Geoffrey L. Uy
        • Contato:
      • Creve Coeur, Missouri, Estados Unidos, 63141
        • Recrutamento
        • Siteman Cancer Center at West County Hospital
        • Investigador principal:
          • Geoffrey L. Uy
        • Contato:
      • Joplin, Missouri, Estados Unidos, 64804
        • Suspenso
        • Freeman Health System
      • Joplin, Missouri, Estados Unidos, 64804
        • Suspenso
        • Mercy Hospital Joplin
      • Rolla, Missouri, Estados Unidos, 65401
        • Suspenso
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Estados Unidos, 65401
        • Suspenso
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Estados Unidos, 64506
        • Suspenso
        • Heartland Regional Medical Center
      • Springfield, Missouri, Estados Unidos, 65804
        • Suspenso
        • Mercy Hospital Springfield
      • Springfield, Missouri, Estados Unidos, 65807
        • Suspenso
        • CoxHealth South Hospital
      • St Louis, Missouri, Estados Unidos, 63110
        • Recrutamento
        • Washington University School of Medicine
        • Investigador principal:
          • Geoffrey L. Uy
        • Contato:
      • St Louis, Missouri, Estados Unidos, 63128
        • Recrutamento
        • Mercy Hospital South
        • Investigador principal:
          • Jay W. Carlson
        • Contato:
      • St Louis, Missouri, Estados Unidos, 63141
        • Recrutamento
        • Mercy Hospital Saint Louis
        • Investigador principal:
          • Jay W. Carlson
        • Contato:
          • Site Public Contact
          • Número de telefone: 314-251-7066
      • St Louis, Missouri, Estados Unidos, 63129
        • Recrutamento
        • Siteman Cancer Center-South County
        • Investigador principal:
          • Geoffrey L. Uy
        • Contato:
      • St Louis, Missouri, Estados Unidos, 63109
        • Suspenso
        • Mercy Infusion Center - Chippewa
      • Washington, Missouri, Estados Unidos, 63090
        • Suspenso
        • Mercy Hospital Washington
    • Montana
      • Anaconda, Montana, Estados Unidos, 59711
        • Recrutamento
        • Community Hospital of Anaconda
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Billings, Montana, Estados Unidos, 59101
        • Recrutamento
        • Billings Clinic Cancer Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Billings, Montana, Estados Unidos, 59101
        • Suspenso
        • Saint Vincent Healthcare
      • Billings, Montana, Estados Unidos, 59102
        • Suspenso
        • Saint Vincent Frontier Cancer Center
      • Bozeman, Montana, Estados Unidos, 59715
        • Recrutamento
        • Bozeman Health Deaconess Hospital
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Butte, Montana, Estados Unidos, 59701
        • Suspenso
        • Saint James Community Hospital and Cancer Treatment Center
      • Great Falls, Montana, Estados Unidos, 59405
        • Suspenso
        • Great Falls Clinic
      • Great Falls, Montana, Estados Unidos, 59405
        • Recrutamento
        • Benefis Sletten Cancer Institute
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Kalispell, Montana, Estados Unidos, 59901
        • Recrutamento
        • Logan Health Medical Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
      • Missoula, Montana, Estados Unidos, 59802
        • Suspenso
        • Saint Patrick Hospital - Community Hospital
      • Missoula, Montana, Estados Unidos, 59804
        • Recrutamento
        • Community Medical Center
        • Investigador principal:
          • John M. Schallenkamp
        • Contato:
    • Nebraska
      • Bellevue, Nebraska, Estados Unidos, 68123
        • Recrutamento
        • Nebraska Medicine-Bellevue
        • Investigador principal:
          • Krishna Gundabolu
        • Contato:
          • Site Public Contact
          • Número de telefone: 402-559-6941
          • E-mail: unmcrsa@unmc.edu
      • Omaha, Nebraska, Estados Unidos, 68198
        • Recrutamento
        • University of Nebraska Medical Center
        • Investigador principal:
          • Krishna Gundabolu
        • Contato:
          • Site Public Contact
          • Número de telefone: 402-559-6941
          • E-mail: unmcrsa@unmc.edu
      • Omaha, Nebraska, Estados Unidos, 68118
        • Recrutamento
        • Nebraska Medicine-Village Pointe
        • Investigador principal:
          • Krishna Gundabolu
        • Contato:
          • Site Public Contact
          • Número de telefone: 402-559-5600
    • Nevada
      • Carson City, Nevada, Estados Unidos, 89703
        • Suspenso
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, Estados Unidos, 89052
        • Suspenso
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Estados Unidos, 89052
        • Suspenso
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Estados Unidos, 89052
        • Suspenso
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, Estados Unidos, 89052
        • Suspenso
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Estados Unidos, 89074
        • Suspenso
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Estados Unidos, 89074
        • Suspenso
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, Estados Unidos, 89074
        • Suspenso
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, Estados Unidos, 89074
        • Suspenso
        • Urology Specialists of Nevada - Green Valley
      • Henderson, Nevada, Estados Unidos, 89074
        • Suspenso
        • Oncology Las Vegas - Henderson
      • Las Vegas, Nevada, Estados Unidos, 89102
        • Suspenso
        • Desert West Surgery
      • Las Vegas, Nevada, Estados Unidos, 89074
        • Suspenso
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, Estados Unidos, 89102
        • Suspenso
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Estados Unidos, 89103
        • Suspenso
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, Estados Unidos, 89106
        • Suspenso
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Estados Unidos, 89106
        • Suspenso
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, Estados Unidos, 89109
        • Suspenso
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, Estados Unidos, 89113
        • Suspenso
        • Las Vegas Prostate Cancer Center
      • Las Vegas, Nevada, Estados Unidos, 89113
        • Suspenso
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, Estados Unidos, 89113
        • Suspenso
        • Urology Specialists of Nevada - Southwest
      • Las Vegas, Nevada, Estados Unidos, 89119
        • Suspenso
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Suspenso
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Suspenso
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Suspenso
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Suspenso
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Suspenso
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Suspenso
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, Estados Unidos, 89135
        • Suspenso
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Estados Unidos, 89144
        • Suspenso
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, Estados Unidos, 89144
        • Suspenso
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Estados Unidos, 89144
        • Suspenso
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, Estados Unidos, 89148-2405
        • Suspenso
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Estados Unidos, 89148
        • Suspenso
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Estados Unidos, 89169
        • Suspenso
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Estados Unidos, 89169
        • Suspenso
        • University Cancer Center
      • Las Vegas, Nevada, Estados Unidos, 89102
        • Suspenso
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Estados Unidos, 89128
        • Suspenso
        • Oncology Las Vegas - Tenaya
      • Las Vegas, Nevada, Estados Unidos, 89183
        • Suspenso
        • OptumCare Cancer Care at Fort Apache
      • Pahrump, Nevada, Estados Unidos, 89048
        • Suspenso
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, Estados Unidos, 89502
        • Suspenso
        • Renown Regional Medical Center
      • Reno, Nevada, Estados Unidos, 89503
        • Suspenso
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, Estados Unidos, 89509
        • Suspenso
        • Radiation Oncology Associates
    • New Mexico
      • Albuquerque, New Mexico, Estados Unidos, 87106
        • Ativo, não recrutando
        • University of New Mexico Cancer Center
    • New York
      • Buffalo, New York, Estados Unidos, 14263
        • Recrutamento
        • Roswell Park Cancer Institute
        • Investigador principal:
          • Eunice S. Wang
        • Contato:
      • Lake Success, New York, Estados Unidos, 11042
        • Recrutamento
        • Northwell Health/Center for Advanced Medicine
        • Contato:
          • Site Public Contact
          • Número de telefone: 516-734-8896
        • Investigador principal:
          • Bradley H. Goldberg
      • Manhasset, New York, Estados Unidos, 11030
        • Recrutamento
        • North Shore University Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 516-734-8896
        • Investigador principal:
          • Bradley H. Goldberg
      • New Hyde Park, New York, Estados Unidos, 11040
        • Recrutamento
        • Long Island Jewish Medical Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 516-734-8896
        • Investigador principal:
          • Bradley H. Goldberg
      • New York, New York, Estados Unidos, 10029
        • Recrutamento
        • Mount Sinai Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-824-7309
          • E-mail: CCTO@mssm.edu
        • Investigador principal:
          • Hannah Levavi
      • New York, New York, Estados Unidos, 10065
        • Recrutamento
        • NYP/Weill Cornell Medical Center
        • Contato:
          • Site Public Contact
          • Número de telefone: 212-746-1848
        • Investigador principal:
          • Gail J. Roboz
      • Rochester, New York, Estados Unidos, 14642
        • Recrutamento
        • University of Rochester
        • Contato:
          • Site Public Contact
          • Número de telefone: 585-275-5830
        • Investigador principal:
          • Kristen M. O'Dwyer
      • Stony Brook, New York, Estados Unidos, 11794
        • Ativo, não recrutando
        • Stony Brook University Medical Center
      • Syracuse, New York, Estados Unidos, 13210
        • Ativo, não recrutando
        • State University of New York Upstate Medical University
      • Verona, New York, Estados Unidos, 13478
        • Ativo, não recrutando
        • Upstate Cancer Center at Verona
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • Recrutamento
        • UNC Lineberger Comprehensive Cancer Center
        • Contato:
        • Investigador principal:
          • Daniel R. Richardson
      • Durham, North Carolina, Estados Unidos, 27710
        • Ativo, não recrutando
        • Duke University Medical Center
      • Greenville, North Carolina, Estados Unidos, 27834
        • Recrutamento
        • East Carolina University
        • Investigador principal:
          • Darla K. Liles
        • Contato:
          • Site Public Contact
          • Número de telefone: 252-744-1015
          • E-mail: eubankss@ecu.edu
      • Winston-Salem, North Carolina, Estados Unidos, 27157
        • Recrutamento
        • Wake Forest University Health Sciences
        • Contato:
          • Site Public Contact
          • Número de telefone: 336-713-6771
        • Investigador principal:
          • Bayard L. Powell
    • North Dakota
      • Fargo, North Dakota, Estados Unidos, 58103
        • Suspenso
        • Essentia Health Cancer Center-South University Clinic
      • Jamestown, North Dakota, Estados Unidos, 58401
        • Suspenso
        • Essentia Health - Jamestown Clinic
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45219
        • Recrutamento
        • University of Cincinnati Cancer Center-UC Medical Center
        • Investigador principal:
          • Emily K. Curran
        • Contato:
      • Cleveland, Ohio, Estados Unidos, 44195
        • Recrutamento
        • Cleveland Clinic Foundation
        • Contato:
        • Investigador principal:
          • Anjali S. Advani
      • Cleveland, Ohio, Estados Unidos, 44106
        • Recrutamento
        • Case Western Reserve University
        • Investigador principal:
          • Brenda W. Cooper
        • Contato:
      • Columbus, Ohio, Estados Unidos, 43210
        • Recrutamento
        • Ohio State University Comprehensive Cancer Center
        • Investigador principal:
          • Meixiao Long
        • Contato:
      • West Chester, Ohio, Estados Unidos, 45069
        • Recrutamento
        • University of Cincinnati Cancer Center-West Chester
        • Investigador principal:
          • Emily K. Curran
        • Contato:
    • Oklahoma
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • Recrutamento
        • University of Oklahoma Health Sciences Center
        • Contato:
        • Investigador principal:
          • Mohamad Khawandanah
      • Oklahoma City, Oklahoma, Estados Unidos, 73120
        • Suspenso
        • Mercy Hospital Oklahoma City
    • Oregon
      • Baker City, Oregon, Estados Unidos, 97814
        • Suspenso
        • Saint Alphonsus Cancer Care Center-Baker City
      • Bend, Oregon, Estados Unidos, 97701
        • Suspenso
        • Saint Charles Health System
      • Clackamas, Oregon, Estados Unidos, 97015
        • Suspenso
        • Clackamas Radiation Oncology Center
      • Clackamas, Oregon, Estados Unidos, 97015
        • Suspenso
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Estados Unidos, 97420
        • Suspenso
        • Bay Area Hospital
      • Newberg, Oregon, Estados Unidos, 97132
        • Recrutamento
        • Providence Newberg Medical Center
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
      • Ontario, Oregon, Estados Unidos, 97914
        • Recrutamento
        • Saint Alphonsus Cancer Care Center-Ontario
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Portland, Oregon, Estados Unidos, 97239
        • Recrutamento
        • Oregon Health and Science University
        • Contato:
          • Site Public Contact
          • Número de telefone: 503-494-1080
          • E-mail: trials@ohsu.edu
        • Investigador principal:
          • Brandon M. Hayes-Lattin
      • Portland, Oregon, Estados Unidos, 97213
        • Recrutamento
        • Providence Portland Medical Center
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
      • Portland, Oregon, Estados Unidos, 97225
        • Recrutamento
        • Providence Saint Vincent Medical Center
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
      • Redmond, Oregon, Estados Unidos, 97756
        • Suspenso
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, Estados Unidos, 18103
        • Recrutamento
        • Lehigh Valley Hospital-Cedar Crest
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • Bethlehem, Pennsylvania, Estados Unidos, 18017
        • Recrutamento
        • Lehigh Valley Hospital - Muhlenberg
        • Contato:
        • Investigador principal:
          • Tareq Al baghdadi
      • East Stroudsburg, Pennsylvania, Estados Unidos, 18301
        • Suspenso
        • Pocono Medical Center
      • Hazleton, Pennsylvania, Estados Unidos, 18201
        • Suspenso
        • Lehigh Valley Hospital-Hazleton
      • Philadelphia, Pennsylvania, Estados Unidos, 19107
        • Recrutamento
        • Thomas Jefferson University Hospital
        • Investigador principal:
          • Lindsay Wilde
        • Contato:
      • Philadelphia, Pennsylvania, Estados Unidos, 19104
        • Recrutamento
        • University of Pennsylvania/Abramson Cancer Center
        • Investigador principal:
          • Keith W. Pratz
        • Contato:
      • Pittsburgh, Pennsylvania, Estados Unidos, 15232
        • Ativo, não recrutando
        • UPMC Hillman Cancer Center
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Recrutamento
        • Rhode Island Hospital
        • Contato:
          • Site Public Contact
          • Número de telefone: 401-444-1488
        • Investigador principal:
          • Rabin Niroula
      • Providence, Rhode Island, Estados Unidos, 02906
        • Suspenso
        • Miriam Hospital
    • South Carolina
      • Boiling Springs, South Carolina, Estados Unidos, 29316
        • Recrutamento
        • Prisma Health Cancer Institute - Spartanburg
        • Investigador principal:
          • Ki Y. Chung
        • Contato:
      • Clinton, South Carolina, Estados Unidos, 29325
        • Suspenso
        • Prisma Health Cancer Institute - Laurens
      • Columbia, South Carolina, Estados Unidos, 29203
        • Recrutamento
        • Prisma Health Richland Hospital
        • Investigador principal:
          • Ki Y. Chung
        • Contato:
      • Easley, South Carolina, Estados Unidos, 29640
        • Recrutamento
        • Prisma Health Cancer Institute - Easley
        • Investigador principal:
          • Ki Y. Chung
        • Contato:
      • Greenville, South Carolina, Estados Unidos, 29601
        • Recrutamento
        • Saint Francis Hospital
        • Investigador principal:
          • Stephen H. Dyar
        • Contato:
      • Greenville, South Carolina, Estados Unidos, 29605
        • Recrutamento
        • Prisma Health Cancer Institute - Faris
        • Investigador principal:
          • Ki Y. Chung
        • Contato:
      • Greenville, South Carolina, Estados Unidos, 29607
        • Recrutamento
        • Saint Francis Cancer Center
        • Investigador principal:
          • Stephen H. Dyar
        • Contato:
      • Greenville, South Carolina, Estados Unidos, 29605
        • Recrutamento
        • Prisma Health Cancer Institute - Butternut
        • Investigador principal:
          • Ki Y. Chung
        • Contato:
      • Greenville, South Carolina, Estados Unidos, 29615
        • Recrutamento
        • Prisma Health Cancer Institute - Eastside
        • Investigador principal:
          • Ki Y. Chung
        • Contato:
      • Greenville, South Carolina, Estados Unidos, 29605
        • Recrutamento
        • Prisma Health Greenville Memorial Hospital
        • Investigador principal:
          • Ki Y. Chung
        • Contato:
      • Greenville, South Carolina, Estados Unidos, 29605
        • Suspenso
        • BI-LO Charities Children's Cancer Center
      • Greer, South Carolina, Estados Unidos, 29650
        • Recrutamento
        • Prisma Health Cancer Institute - Greer
        • Investigador principal:
          • Ki Y. Chung
        • Contato:
      • Seneca, South Carolina, Estados Unidos, 29672
        • Recrutamento
        • Prisma Health Cancer Institute - Seneca
        • Investigador principal:
          • Ki Y. Chung
        • Contato:
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • Recrutamento
        • Houston Methodist Hospital
        • Investigador principal:
          • Siddhartha Ganguly
        • Contato:
          • Site Public Contact
          • Número de telefone: 713-790-2700
      • Lubbock, Texas, Estados Unidos, 79410
        • Ativo, não recrutando
        • Covenant Medical Center-Lakeside
    • Utah
      • American Fork, Utah, Estados Unidos, 84003
        • Suspenso
        • American Fork Hospital / Huntsman Intermountain Cancer Center
      • Cedar City, Utah, Estados Unidos, 84720
        • Suspenso
        • Sandra L Maxwell Cancer Center
      • Logan, Utah, Estados Unidos, 84321
        • Suspenso
        • Logan Regional Hospital
      • Murray, Utah, Estados Unidos, 84107
        • Suspenso
        • Intermountain Medical Center
      • Ogden, Utah, Estados Unidos, 84403
        • Suspenso
        • McKay-Dee Hospital Center
      • Provo, Utah, Estados Unidos, 84604
        • Suspenso
        • Utah Valley Regional Medical Center
      • Riverton, Utah, Estados Unidos, 84065
        • Suspenso
        • Riverton Hospital
      • Salt Lake City, Utah, Estados Unidos, 84112
        • Recrutamento
        • Huntsman Cancer Institute/University of Utah
        • Contato:
        • Investigador principal:
          • Paul J. Shami
      • Salt Lake City, Utah, Estados Unidos, 84106
        • Suspenso
        • Utah Cancer Specialists-Salt Lake City
      • Salt Lake City, Utah, Estados Unidos, 84143
        • Suspenso
        • LDS Hospital
      • St. George, Utah, Estados Unidos, 84770
        • Suspenso
        • Saint George Regional Medical Center
    • Virginia
      • Fairfax, Virginia, Estados Unidos, 22031
        • Ativo, não recrutando
        • Inova Schar Cancer Institute
      • Falls Church, Virginia, Estados Unidos, 22042
        • Ativo, não recrutando
        • Inova Fairfax Hospital
      • Richmond, Virginia, Estados Unidos, 23298
        • Recrutamento
        • VCU Massey Comprehensive Cancer Center
        • Investigador principal:
          • Keri R. Maher
        • Contato:
    • Washington
      • Aberdeen, Washington, Estados Unidos, 98520
        • Suspenso
        • Providence Regional Cancer System-Aberdeen
      • Bellevue, Washington, Estados Unidos, 98004
        • Suspenso
        • Overlake Medical Center
      • Bellingham, Washington, Estados Unidos, 98225
        • Suspenso
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Estados Unidos, 98531
        • Suspenso
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Estados Unidos, 98026
        • Recrutamento
        • Swedish Cancer Institute-Edmonds
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
      • Everett, Washington, Estados Unidos, 98201
        • Suspenso
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, Estados Unidos, 98029
        • Suspenso
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Estados Unidos, 99336
        • Suspenso
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Estados Unidos, 98503
        • Suspenso
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Estados Unidos, 98632
        • Suspenso
        • PeaceHealth Saint John Medical Center
      • Port Townsend, Washington, Estados Unidos, 98368
        • Ativo, não recrutando
        • Jefferson Healthcare
      • Renton, Washington, Estados Unidos, 98055
        • Suspenso
        • Valley Medical Center
      • Seattle, Washington, Estados Unidos, 98104
        • Suspenso
        • Pacific Gynecology Specialists
      • Seattle, Washington, Estados Unidos, 98107
        • Suspenso
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Estados Unidos, 98122-5711
        • Suspenso
        • Swedish Medical Center-Cherry Hill
      • Seattle, Washington, Estados Unidos, 98122
        • Recrutamento
        • Swedish Medical Center-First Hill
        • Investigador principal:
          • Alison K. Conlin
        • Contato:
      • Seattle, Washington, Estados Unidos, 98112
        • Ativo, não recrutando
        • Kaiser Permanente Washington
      • Sedro-Woolley, Washington, Estados Unidos, 98284
        • Suspenso
        • PeaceHealth United General Medical Center
      • Shelton, Washington, Estados Unidos, 98584
        • Suspenso
        • Providence Regional Cancer System-Shelton
      • Vancouver, Washington, Estados Unidos, 98664
        • Suspenso
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Estados Unidos, 99362
        • Suspenso
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, Estados Unidos, 98902
        • Suspenso
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, Estados Unidos, 98597
        • Suspenso
        • Providence Regional Cancer System-Yelm
    • Wisconsin
      • Ashland, Wisconsin, Estados Unidos, 54806
        • Suspenso
        • Northwest Wisconsin Cancer Center
      • Ashland, Wisconsin, Estados Unidos, 54806
        • Suspenso
        • Duluth Clinic Ashland
      • Hayward, Wisconsin, Estados Unidos, 54843
        • Suspenso
        • Essentia Health-Hayward Clinic
      • Madison, Wisconsin, Estados Unidos, 53792
        • Recrutamento
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Investigador principal:
          • Ryan J. Mattison
        • Contato:
      • Madison, Wisconsin, Estados Unidos, 53718
        • Recrutamento
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • Investigador principal:
          • Ryan J. Mattison
        • Contato:
      • Marshfield, Wisconsin, Estados Unidos, 54449
      • Milwaukee, Wisconsin, Estados Unidos, 53226
        • Recrutamento
        • Medical College of Wisconsin
        • Contato:
          • Site Public Contact
          • Número de telefone: 414-805-3666
        • Investigador principal:
          • Guru Subramanian Guru Murthy
      • New Richmond, Wisconsin, Estados Unidos, 54017
        • Suspenso
        • Cancer Center of Western Wisconsin
      • Spooner, Wisconsin, Estados Unidos, 54801
        • Suspenso
        • Essentia Health-Spooner Clinic
      • Superior, Wisconsin, Estados Unidos, 54880
        • Suspenso
        • Essentia Health Saint Mary's Hospital - Superior
    • Wyoming
      • Cheyenne, Wyoming, Estados Unidos, 82001
        • Ativo, não recrutando
        • Cheyenne Regional Medical Center-West
      • Cody, Wyoming, Estados Unidos, 82414
        • Suspenso
        • Billings Clinic-Cody
      • Sheridan, Wyoming, Estados Unidos, 82801
        • Suspenso
        • Welch Cancer Center

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 39 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

REGISTRATION ELIGIBILITY CRITERIA (STEP 1)

  • Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (WHO criteria) are eligible. Patients with Burkitt type ALL are NOT eligible

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Single-dose intrathecal cytarabine is allowed prior to registration or prior to initiation of systematic therapy for patient convenience; this is usually done at the time of the diagnostic bone marrow or venous line placement to avoid a second lumbar puncture; systemic chemotherapy must begin within 72 hours of this intrathecal therapy

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Age >= 18 years and < 40 years

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Eastern Cooperative Oncology Group (ECOG) performance status 0-2

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Aspartate aminotransferase (AST), alanine aminotransferase (ALT) =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Direct bilirubin =< 3 x upper limit of normal (ULN), unless suspected leukemic involvement of the liver

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Calculated (calc.) creatinine clearance >= 50 mL/min by Cockcroft-Gault

  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Completion of remission induction therapy

  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) CONFIRMATION OF TOLERABILITY AND PHASE III ONLY):Patients with M2 marrow or better are eligible; patients with M3 or M4 marrow (greater than 25% lymphoblasts) will not be eligible to be randomized

    • Rating: M0, M1; Blast Cells (%): 0-5.0
    • Rating: M2; Blast Cells (%): 5.1-25.0
    • Rating: M3; Blast Cells (%): > 25-50
    • Rating: M4; Blast Cells (%): > 50.0
    • The term "blast cell" includes any cell that cannot be classified as a more mature normal element, and includes "leukemic cells," pathologic lymphocytes, and stem cells

  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Absolute neutrophil count (ANC) >= 750/mm^3

  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Platelet count >= 75,000/mm^3

  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Total bilirubin =< 1.5 x upper limit of normal (ULN), except for patients with known Gilbert's syndrome

  • RANDOMIZATION ELIGIBILITY CRITERIA (STEP 2) (CONFIRMATION OF TOLERABILITY AND PHASE III ONLY): Aspartate aminotransferase (AST) =< 8 x upper limit of normal (ULN)

EXCLUSION CRITERIA

  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(9;22)(q34;q11) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: patients must also be assessed for CD20 positivity and other markers; positivity for CD22 and CD20 is defined as baseline expression of the CD22 or CD20 antigen in more than 20% of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD45 expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for ALL except for limited treatment (=< 7 days) with corticosteroids or hydroxyurea and a single dose of intrathecal cytarabine; however, patients who are being treated with chronic steroids for other reasons (for example, to treat asthma, autoimmune disorders, lupus, etc.) are eligible
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): No prior therapy for acute leukemia except emergency therapy (corticosteroids or hydroxyurea) for blast cell crisis, superior vena cava syndrome, or renal failure due to leukemic infiltration of the kidneys; when indicated, leukapheresis or exchange transfusion is recommended to reduce the WBC
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects; therefore, for women of childbearing potential only, a negative urine or serum pregnancy test done =< 8 days prior to registration is required
  • REGISTRATION ELIGIBILITY CRITERIA (STEP 1): Patients with down syndrome are excluded from this study due to the likelihood of excessive toxicity resulting; these patients should be treated in consultation with a pediatric oncologist

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador Ativo: Arm I (frontline chemotherapy)

See detailed description.
Outro: Laboratory Biomarker Analysis

Correlative studies

Medicamento: Cyclophosphamide

Given IV

Biológico: Rituximab

Given IV

Medicamento: Vincristine Sulfate

Given IV

Medicamento: Daunorubicin Hydrochloride

Given IV

Medicamento: Mercaptopurine

Given PO

Medicamento: Dexamethasone

Given PO or IV

Medicamento: Thioguanine

Given PO

Medicamento: Allopurinol

Given PO

Medicamento: Cytarabine

Given IT, IV, SC

Medicamento: Pegylated L-Asparaginase

Given IV

Medicamento: Methotrexate

Given IT, IV, PO

Procedimento: Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy
Experimental: Arm II (frontline chemotherapy, inotuzumab ozogamicin)

Patients receive inotuzumab ozogamicin IV on days 1, 8, and 15 and undergo bone marrow aspirate and biopsy on day 28. Treatment repeats every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients who are MRD+ and CD19+ after completion of 2 cycles of inotuzumab ozogamicin receive dexamethasone IV or PO on day 1 and blinatumomab IV via continuous infusion on days 1-28, followed by a 14 day break. Cycles repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive remission consolidated chemotherapy, interim maintenance chemotherapy, delayed intensification, and maintenance therapy as in Arm I. Patients undergo MUGA or echocardiography and x ray imaging during screening, bone marrow aspiration and biopsy and lumbar puncture and blood sample collection throughout the study.
Outro: Laboratory Biomarker Analysis

Correlative studies

Medicamento: Cyclophosphamide

Given IV

Medicamento: Doxorubicin

Given IV

Biológico: Rituximab

Given IV

Medicamento: Vincristine Sulfate

Given IV

Medicamento: Daunorubicin Hydrochloride

Given IV

Medicamento: Mercaptopurine

Given PO

Biológico: Inotuzumab Ozogamicin

Given IV

Medicamento: Dexamethasone

Given PO or IV

Medicamento: Thioguanine

Given PO

Medicamento: Allopurinol

Given PO

Medicamento: Cytarabine

Given IT, IV, SC

Medicamento: Pegylated L-Asparaginase

Given IV

Medicamento: Methotrexate

Given IT, IV, PO

Procedimento: Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration and biopsy

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Event-free survival (EFS)
Prazo: Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years

The EFS distributions between the two arms will be compared using non-stratified log-rank tests. EFS curves will be constructed using the Kaplan-Meier product limit method, and additional analyses will be done using the Cox proportional hazards model. with diagnostics test on proportional hazard assumptions first. The corresponding hazard ratio, 2- and 3-year EFS estimates will be assessed, and EFS medians along with their 95% confidence intervals for the two treatment arms.
Time from induction response to the time of progressive-disease, secondary malignancy, or death, assessed up to 3 years

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Disease-free survival (DFS)
Prazo: Time from achievement of complete response (CR) to the time of relapse and/or death, assessed up to 10 years
Time from achievement of complete response (CR) to the time of relapse and/or death, assessed up to 10 years
Overall Survival (OS)
Prazo: Time from randomization to the time of death due to any cause, assessed up to 10 years

Will be evaluated using Kaplan-Meier as well as Cox regression models.
Time from randomization to the time of death due to any cause, assessed up to 10 years
Proportion of patients who achieve CR or any response to induction therapy
Prazo: Up to 10 years

Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.
Up to 10 years
Overall induction response rates
Prazo: Up to 10 years

Will be summarized as the proportion of patients who achieve any type of response to induction therapy divided by the number of all evaluable patients registered to this trial and who received at least one dose of induction therapy. Corresponding 95% binomial confidence intervals will also be calculated.
Up to 10 years
Incidence of adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0
Prazo: Up to 10 years

The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. In addition, all adverse event data that is graded as 3, 4, or 5 will be reviewed and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The incidence of severe (grade 3+) adverse events or toxicities will be described for each treatment arm, but will also be compared between the arms. Fisher's exact tests will be used to quantitatively compare the incidence of severe as well as specific toxicities of interest between the treatment arms and we will graphically assess differences in maximum grades observed for toxicities between the arms. Tolerability of the treatment arms will be assessed through assessing the number of patients who required dose modifications and/or dose delays.
Up to 10 years
Proportion of patients who go off treatment due to adverse reactions
Prazo: Up to 10 years

Will be assessed within each of the treatment arms and differences explores in these measures between the arms.
Up to 10 years
Proportion of patients who refuse further treatment for lesser toxicities that inhibit their willingness to continue participation on the trial
Prazo: Up to 10 years

Will be assessed within each of the treatment arms and differences explores in these measures between the arms.
Up to 10 years

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Alliance for Clinical Trials in Oncology

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Cadeira de estudo: daniel_deangelo@dfci.harvard.edu J. DeAngelo, MD, PhD, Dana-Farber Cancer Institute

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

20 de setembro de 2017

Conclusão Primária (Estimado)

1 de novembro de 2027

Conclusão do estudo (Estimado)

1 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

9 de maio de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

10 de maio de 2017

Primeira postagem (Real)

12 de maio de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

3 de novembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

2 de novembro de 2026

Última verificação

1 de novembro de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • A041501
  • U10CA180821 (Concessão/Contrato do NIH dos EUA)
  • NCI-2016-01981 (Identificador de registro: Clinical Trial Reporting Program)

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Sim

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever