Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Inotuzumab, ozogamicin a blinatumomab v léčbě pacientů s nově diagnostikovanou, recidivující nebo refrakterní CD22-pozitivní akutní lymfoblastickou leukémií B-linie

11. listopadu 2026 aktualizováno: National Cancer Institute (NCI)

Studie fáze II inotuzumab ozogamicinu následovaná Blinatumomabem pro Ph-negativní CD22-pozitivní akutní lymfoblastickou leukémii řady B u nově diagnostikovaných starších dospělých nebo dospělých s relapsem nebo refrakterním onemocněním

This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). 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. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

PRIMARY OBJECTIVES:

Ia. For Philadelphia (Ph)-negative B-cell acute lymphoblastic leukemia (ALL), to confirm tolerability of the combination regimen of inotuzumab ozogamicin followed by blinatumomab.

Ib. For Ph-positive B-cell ALL, to confirm tolerability of ponatinib in combination with inotuzumab ozogamicin and blinatumomab.

II. To estimate the 1-year event-free survival of older, transplant-ineligible patients with newly diagnosed, Ph-negative, CD22-positive, B-cell acute lymphoblastic leukemia (ALL) treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 1) III. To estimate the 1-year event-free survival of patients with relapsed or refractory Ph-negative, CD22-positive, B-cell ALL treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 2) IV. To determine the feasibility of the regimen in adult patients with CD22-positive, Ph/BCR-ABL1-positive B-cell ALL. (Cohort 3)

SECONDARY OBJECTIVES:

I. To estimate the median, 1-year, and 3-year overall survival (OS) in all eligible patients. (Cohort 1) II. To estimate the median, 1-year, and 3-year relapse-free survival (RFS) in all eligible patients. (Cohort 1) III. To estimate the median and 3-year event-free survival (EFS) in all eligible patients. (Cohort 1) IV. To estimate the complete response (CR) rate and overall response rate (ORR, defined as complete response [CR] + complete response with incomplete count recovery [CRi]) to inotuzumab ozogamicin followed by blinatumomab (regimen CR rate and ORR). (Cohort 1) V. To estimate the CR rate and ORR (CR + CRi) to inotuzumab ozogamicin induction alone (induction CR and ORR). (Cohort 1) VI. To estimate the minimal residual disease (MRD) negativity rate in subjects achieving a CR or CRi. (Cohort 1) VII. To estimate the treatment-related mortality with this regimen. (Cohort 1) VIII. To describe the safety and tolerability of this regimen. (Cohort 1) IX. To estimate the median, 1-year, and 3-year OS in all eligible patients. (Cohort 2) X. To estimate the median, 1-year, and 3-year RFS in all eligible patients. (Cohort 2) XI. To estimate the median and 3-year EFS in all eligible patients. (Cohort 2) XII. To estimate ORR (CR/CRi and CR/complete response with partial hematologic recovery [CRh]) to blinatumomab in patients with ALL refractory to inotuzumab ozogamicin. (Cohort 2) XIII. To estimate the CR, CRi, and CRh rates at defined time points and cumulatively for the entire regimen. (Cohort 2) XIV. To determine the MRD negativity (< 10^-4) rate at defined time points including prior to allogeneic HCT and cumulatively in patients achieving a CR, CRh, or CRi. (Cohort 2) XV. To determine the allogeneic hematopoietic cell transplantation (HCT) rate in eligible subjects. (Cohort 2) XVI. To estimate the treatment-related mortality with this regimen. (Cohort 2) XVII. To describe the safety and tolerability of this regimen. (Cohort 2) XVIII. To estimate the 24-week complete molecular response rate. (Cohort 3) XIX. To estimate the median, 1-year, and 3-year OS in all eligible patients. (Cohort 3) XX. To estimate the median, 1-year, and 3-year RFS in all eligible patients. (Cohort 3) XXI. To estimate the median and 3-year EFS in all eligible patients. (Cohort 3) XXII. To estimate ORR (CR/CRi and CR/complete response with partial hematologic recovery [CRh]) to blinatumomab in patients with ALL refractory to inotuzumab ozogamicin. (Cohort 3) XXIII. To estimate the CR, CRi, and CRh rates at defined time points and cumulatively for the entire regimen. (Cohort 3) XXIV. To determine the complete molecular response rate at defined time points and cumulatively in patients achieving a CR, CRh, or CRi. (Cohort 3) XXV. To estimate the treatment-related mortality with this regimen. (Cohort 3) XXVI. To describe the safety and tolerability of this regimen. (Cohort 3)

OTHER OBJECTIVE:

I. Results of the primary analysis will be examined for consistency, while accounting for the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue.

CORRELATIVE SCIENCE OBJECTIVES:

I. To correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters.

II. To correlate specific karyotype groups with response rates, response duration, survival, and cure in patients treated with inotuzumab ozogamicin followed by blinatumomab.

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

V. To assess the correlation of quantitative MRD post-induction with inotuzumab ozogamicin and at sequential consolidation time points with blinatumomab with RFS, EFS, and OS.

VI. To correlate the influence of MRD status (detectable versus [vs.] not and as a continuous measure) in relation to EFS, RFS, and OS with other clinical and biological factors (e.g. previously untreated vs. relapsed disease cohorts; age, initial white blood cell [WBC] count, cytogenetics).

VII. To identify genetic variants and predictors of ex vivo resistance. VIII. To identify genetic variants and predictors of MRD. IX. To identify genetic variants and predictors of relapse. X. To determine inter-patient variability in drug sensitivity of adult ALL. XI. To examine the associations of drug sensitivity with host and leukemia molecular features.

XII. To evaluate T-cell populations and T-cell function during therapy using T-cell markers which include the T-cell subset defining markers CD45, CD3, CD4, CD8, CD45RA, CD45RO, CCR7, CD25, CD127, FOXP3, CD 27, CD28, among others, and markers of T cell exhaustion and senescence including CD57, PD-1, Tim-3, LAG-3, TIGIT, CTLA4, CD160, and ICOS among others.

XIII. To evaluate cytokine levels, and compare between patients who attain a CR vs. those with stable or progressive disease.

EXPLORATORY OBJECTIVES:

I. To estimate the median, 1-year, and 3-year RFS, EFS, and OS in patients achieving a CR/CRi to inotuzumab ozogamicin. (Cohort 1) II. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi to inotuzumab ozogamicin. (Cohort 1) III. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi at any time. (Cohort 1) IV. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 1) V. To estimate the rate of cytokine release syndrome in this population. (Cohort 1) VI. To estimate the median, 1-year, and 3-year RFS from time of CR/CRi to inotuzumab ozogamicin in patients receiving inotuzumab ozogamicin followed by blinatumomab and not undergoing allogeneic hematopoietic cell transplantation (HCT). (Cohort 2) VII. To estimate median, 1-year, and 3-year OS after CR/CRi to inotuzumab ozogamicin in patients not undergoing allogeneic HCT. (Cohort 2) VIII. To compare in a non-randomized fashion median, 1-year, and 3-year OS, median, 1-year, and 3-year RFS, cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) between patients achieving CR/CRi and receiving consolidation with or without allogeneic HCT. (Cohort 2) IX. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 2) X. To estimate the rate of cytokine release syndrome in this population. (Cohort 2) XI. To estimate the median, 1-year, and 3-year RFS, EFS, and OS in patients achieving a CR/CRi to inotuzumab ozogamicin. (Cohort 3) XII. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients with CR/CRi achieving complete molecular response vs. not to inotuzumab ozogamicin. (Cohort 3) XIII. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving CR/CRi achieving complete molecular response vs. not at any time. (Cohort 3) XIV. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 3) XV. To estimate the rate of cytokine release syndrome in this population. (Cohort 3) XVI. To assess ABL1 mutational patterns at relapse. (Cohort 3)

OUTLINE: Patients are assigned to 1 of 2 cohorts.

COHORT 1: Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. By the end of Course II, patients with CR-CRi to Course IB/IC and Course II continue to Course IIIA, patients without adequate ALL cytoreduction to Course IA or refractory to Course IB/IC but CR/CRi to Course II continue to Course IIIB. Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study.

COHORT 2: Patients receive inotuzumab ozogamicin IV over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. Patients with CR/CRi at the end of Course II continue to Course IIIB.

COURSE IB/IC: Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment continues for 1 course (28 days) in the absence of disease progression or unacceptable toxicity.

COURSE II: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity.

COURSE IIIA: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity.

COURSE IIIB: Patients receive blinatumomab IV continuously on days 1-28, 43-70, and 85-112. Treatment continues for 1 course (126 days) in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study.

COHORT 3:

INDUCTION:

COURSE I: Patients receive ponatinib orally (PO) daily (QD) on day 1-35, dexamethasone PO QD on days 1-7 and 15-21 and methotrexate intrathecally (IT) on day 1, 15 and 29 for 1 course (35 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi continue to consolidation course IIA or end the study treatment to receive allogenic HCT per the treating physician. Patients without CR or CRi with but adequate ALL cytoreduction (defined as ≥ 50% reduction in bone marrow lymphoblasts from the pre-registration bone marrow aspirate/biopsy and/or ≤ 20% marrow cellularity at the end of Course I bone marrow aspirate/biopsy) also proceed to consolidation course IIA. Patients with progression or failure to achieve adequate ALL cytoreduction are removed from study treatment.

CONSOLIDATION:

COURSE IIA: Patients receive ponatinib PO QD on days 1-21, inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 and methotrexate IT on day 1 for 1 course (21 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi continue to consolidation course IIB or end the study treatment to receive allogenic HCT per the treating physician. Patients without CR or CRi and without progressive disease proceed to course IIC. Patients with progression are removed from study treatment.

COURSE IIB/C: Patients receive ponatinib PO QD on days 1-28, inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 and methotrexate IT on day 1 for 1 course (28 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi end the study treatment to receive allogenic HCT per the treating physician. Patients with progression are removed from study treatment. All other patients proceed to course III.

COURSE III: Patients receive ponatinib PO QD on days 1-84 and receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. Patients in CR/CRi proceed to course IV. Patients not in CR/CRi are removed from study treatment.

COURSE IV: Patients receive ponatinib PO QD on days 1-84 and receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. Patients in CR/CRi proceed to maintenance. Patients not in CR/CRi are removed from study treatment.

MAINTENANCE: Patients receive ponatinib PO QD for 24 months in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study.

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

Typ studie

Intervenční

Zápis (Odhadovaný)

84

Fáze

  • Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Portoriko
      • San Juan, Portoriko, 00927
        • Nábor
        • Centro Comprensivo de Cancer de UPR
        • Vrchní vyšetřovatel:
          • Luis J. Santos Reyes
        • Kontakt:
      • San Juan, Portoriko, 00936
        • Nábor
        • San Juan City Hospital
        • Vrchní vyšetřovatel:
          • Luis J. Santos Reyes
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 787-763-1296
  • Spojené státy
    • Alabama
      • Birmingham, Alabama, Spojené státy, 35233
        • Aktivní, ne nábor
        • University of Alabama at Birmingham Cancer Center
    • Alaska
      • Anchorage, Alaska, Spojené státy, 98508
        • Pozastaveno
        • Anchorage Associates in Radiation Medicine
      • Anchorage, Alaska, Spojené státy, 99504
        • Pozastaveno
        • Anchorage Radiation Therapy Center
      • Anchorage, Alaska, Spojené státy, 99508
        • Pozastaveno
        • Alaska Breast Care and Surgery LLC
      • Anchorage, Alaska, Spojené státy, 99508
        • Pozastaveno
        • Alaska Oncology and Hematology LLC
      • Anchorage, Alaska, Spojené státy, 99508
        • Pozastaveno
        • Alaska Women's Cancer Care
      • Anchorage, Alaska, Spojené státy, 99508
        • Pozastaveno
        • Anchorage Oncology Centre
      • Anchorage, Alaska, Spojené státy, 99508
        • Pozastaveno
        • Katmai Oncology Group
      • Anchorage, Alaska, Spojené státy, 99508
        • Pozastaveno
        • Providence Alaska Medical Center
    • Arizona
      • Kingman, Arizona, Spojené státy, 86401
        • Pozastaveno
        • Kingman Regional Medical Center
    • Arkansas
      • Fort Smith, Arkansas, Spojené státy, 72903
        • Pozastaveno
        • Mercy Hospital Fort Smith
    • California
      • Arroyo Grande, California, Spojené státy, 93420
        • Pozastaveno
        • PCR Oncology
      • Burbank, California, Spojené státy, 91505
        • Pozastaveno
        • Providence Saint Joseph Medical Center/Disney Family Cancer Center
      • Clovis, California, Spojené státy, 93611
        • Aktivní, ne nábor
        • Community Cancer Institute
      • Clovis, California, Spojené státy, 93611
        • Aktivní, ne nábor
        • University Oncology Associates
      • Duarte, California, Spojené státy, 91010
        • Nábor
        • City of Hope Comprehensive Cancer Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Ibrahim Aldoss
      • Irvine, California, Spojené státy, 92612
        • Nábor
        • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care
        • Vrchní vyšetřovatel:
          • Deepa Jeyakumar
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 877-827-8839
          • E-mail: ucstudy@uci.edu
      • La Jolla, California, Spojené státy, 92093
        • Nábor
        • UC San Diego Moores Cancer Center
        • Vrchní vyšetřovatel:
          • James K. Mangan
        • Kontakt:
      • Orange, California, Spojené státy, 92868
        • Nábor
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
        • Vrchní vyšetřovatel:
          • Deepa Jeyakumar
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 877-827-8839
          • E-mail: ucstudy@uci.edu
      • Palo Alto, California, Spojené státy, 94304
        • Aktivní, ne nábor
        • Stanford Cancer Institute Palo Alto
    • Delaware
      • Lewes, Delaware, Spojené státy, 19958
        • Pozastaveno
        • Beebe Medical Center
      • Millville, Delaware, Spojené státy, 19967
        • Pozastaveno
        • Beebe South Coastal Health Campus
      • Newark, Delaware, Spojené státy, 19713
        • Nábor
        • Helen F Graham Cancer Center
        • Vrchní vyšetřovatel:
          • Gregory A. Masters
        • Kontakt:
      • Newark, Delaware, Spojené státy, 19713
        • Pozastaveno
        • Delaware Clinical and Laboratory Physicians PA
      • Newark, Delaware, Spojené státy, 19713
        • Nábor
        • Medical Oncology Hematology Consultants PA
        • Vrchní vyšetřovatel:
          • Gregory A. Masters
        • Kontakt:
      • Newark, Delaware, Spojené státy, 19718
        • Pozastaveno
        • Christiana Care Health System-Christiana Hospital
      • Rehoboth Beach, Delaware, Spojené státy, 19971
        • Pozastaveno
        • Beebe Health Campus
      • Seaford, Delaware, Spojené státy, 19973
        • Pozastaveno
        • TidalHealth Nanticoke / Allen Cancer Center
      • Wilmington, Delaware, Spojené státy, 19801
        • Pozastaveno
        • Christiana Care Health System-Wilmington Hospital
    • District of Columbia
      • Washington D.C., District of Columbia, Spojené státy, 20007
        • Nábor
        • MedStar Georgetown University Hospital
        • Vrchní vyšetřovatel:
          • Kimberley Doucette
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 202-444-2223
    • Florida
      • Fort Lauderdale, Florida, Spojené státy, 33308
        • Pozastaveno
        • Holy Cross Hospital
      • Jupiter, Florida, Spojené státy, 33458
        • Nábor
        • Jupiter Medical Center
        • Vrchní vyšetřovatel:
          • Ryan H. Devine
        • Kontakt:
    • Georgia
      • Atlanta, Georgia, Spojené státy, 30322
        • Nábor
        • Emory University Hospital/Winship Cancer Institute
        • Vrchní vyšetřovatel:
          • William G. Blum
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 404-778-1868
      • Atlanta, Georgia, Spojené státy, 30342
        • Nábor
        • Emory Saint Joseph's Hospital
        • Vrchní vyšetřovatel:
          • William G. Blum
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 404-851-7115
    • Idaho
      • Boise, Idaho, Spojené státy, 83712
        • Pozastaveno
        • Saint Luke's Cancer Institute - Boise
      • Fruitland, Idaho, Spojené státy, 83619
        • Pozastaveno
        • Saint Luke's Cancer Institute - Fruitland
      • Meridian, Idaho, Spojené státy, 83642
        • Pozastaveno
        • Saint Luke's Cancer Institute - Meridian
      • Nampa, Idaho, Spojené státy, 83687
        • Nábor
        • Saint Alphonsus Cancer Care Center-Nampa
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
      • Nampa, Idaho, Spojené státy, 83687
        • Pozastaveno
        • Saint Luke's Cancer Institute - Nampa
      • Twin Falls, Idaho, Spojené státy, 83301
        • Pozastaveno
        • Saint Luke's Cancer Institute - Twin Falls
    • Illinois
      • Alton, Illinois, Spojené státy, 62002
        • Pozastaveno
        • OSF Saint Anthony's Health Center
      • Bloomington, Illinois, Spojené státy, 61704
        • Pozastaveno
        • Illinois CancerCare-Bloomington
      • Burr Ridge, Illinois, Spojené státy, 60527
        • Pozastaveno
        • Loyola Center for Health at Burr Ridge
      • Canton, Illinois, Spojené státy, 61520
        • Pozastaveno
        • Illinois CancerCare-Canton
      • Carbondale, Illinois, Spojené státy, 62902
        • Pozastaveno
        • Memorial Hospital of Carbondale
      • Carterville, Illinois, Spojené státy, 62918
        • Pozastaveno
        • SIH Cancer Institute
      • Carthage, Illinois, Spojené státy, 62321
        • Pozastaveno
        • Illinois CancerCare-Carthage
      • Centralia, Illinois, Spojené státy, 62801
        • Pozastaveno
        • Centralia Oncology Clinic
      • Chicago, Illinois, Spojené státy, 60637
        • Nábor
        • University of Chicago Comprehensive Cancer Center
        • Vrchní vyšetřovatel:
          • Wendy Stock
        • Kontakt:
      • Chicago, Illinois, Spojené státy, 60611
        • Nábor
        • Northwestern University
        • Vrchní vyšetřovatel:
          • Shira N. Dinner
        • Kontakt:
      • Chicago, Illinois, Spojené státy, 60612
        • Nábor
        • University of Illinois
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 312-355-3046
        • Vrchní vyšetřovatel:
          • John G. Quigley
      • Decatur, Illinois, Spojené státy, 62526
        • Nábor
        • Cancer Care Specialists of Illinois - Decatur
        • Vrchní vyšetřovatel:
          • Bryan A. Faller
        • Kontakt:
      • Decatur, Illinois, Spojené státy, 62526
        • Pozastaveno
        • Decatur Memorial Hospital
      • Dixon, Illinois, Spojené státy, 61021
        • Pozastaveno
        • Illinois CancerCare-Dixon
      • Effingham, Illinois, Spojené státy, 62401
        • Nábor
        • Crossroads Cancer Center
        • Vrchní vyšetřovatel:
          • Bryan A. Faller
        • Kontakt:
      • Eureka, Illinois, Spojené státy, 61530
        • Pozastaveno
        • Illinois CancerCare-Eureka
      • Evanston, Illinois, Spojené státy, 60201
        • Nábor
        • NorthShore University HealthSystem-Evanston Hospital
        • Vrchní vyšetřovatel:
          • Amy Y. Wang
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 847-570-2109
      • Galesburg, Illinois, Spojené státy, 61401
        • Pozastaveno
        • Western Illinois Cancer Treatment Center
      • Galesburg, Illinois, Spojené státy, 61401
        • Pozastaveno
        • Illinois CancerCare-Galesburg
      • Glenview, Illinois, Spojené státy, 60026
        • Nábor
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Vrchní vyšetřovatel:
          • Amy Y. Wang
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 847-570-2109
      • Highland Park, Illinois, Spojené státy, 60035
        • Nábor
        • NorthShore University HealthSystem-Highland Park Hospital
        • Vrchní vyšetřovatel:
          • Amy Y. Wang
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 847-570-2109
      • Homer Glen, Illinois, Spojené státy, 60491
        • Pozastaveno
        • Loyola Medicine Homer Glen
      • Kewanee, Illinois, Spojené státy, 61443
        • Pozastaveno
        • Illinois CancerCare-Kewanee Clinic
      • Lake Forest, Illinois, Spojené státy, 60045
        • Aktivní, ne nábor
        • Northwestern Medicine Lake Forest Hospital
      • Macomb, Illinois, Spojené státy, 61455
        • Pozastaveno
        • Illinois CancerCare-Macomb
      • Maywood, Illinois, Spojené státy, 60153
        • Nábor
        • Loyola University Medical Center
        • Vrchní vyšetřovatel:
          • Stephanie B. Tsai
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 708-226-4357
      • Melrose Park, Illinois, Spojené státy, 60160
        • Pozastaveno
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
      • Mount Vernon, Illinois, Spojené státy, 62864
        • Pozastaveno
        • SSM Health Good Samaritan
      • New Lenox, Illinois, Spojené státy, 60451
        • Nábor
        • UC Comprehensive Cancer Center at Silver Cross
        • Vrchní vyšetřovatel:
          • Wendy Stock
        • Kontakt:
      • O'Fallon, Illinois, Spojené státy, 62269
        • Pozastaveno
        • Cancer Care Center of O'Fallon
      • Orland Park, Illinois, Spojené státy, 60462
        • Nábor
        • University of Chicago Medicine-Orland Park
        • Vrchní vyšetřovatel:
          • Wendy Stock
        • Kontakt:
      • Ottawa, Illinois, Spojené státy, 61350
        • Pozastaveno
        • Illinois CancerCare-Ottawa Clinic
      • Pekin, Illinois, Spojené státy, 61554
        • Pozastaveno
        • Illinois CancerCare-Pekin
      • Pekin, Illinois, Spojené státy, 61554
        • Pozastaveno
        • OSF Saint Francis Radiation Oncology at Pekin
      • Peoria, Illinois, Spojené státy, 61615
        • Nábor
        • Illinois CancerCare-Peoria
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Bryan A. Faller
      • Peoria, Illinois, Spojené státy, 61636
        • Pozastaveno
        • Methodist Medical Center of Illinois
      • Peoria, Illinois, Spojené státy, 61615
        • Pozastaveno
        • OSF Saint Francis Radiation Oncology at Peoria Cancer Center
      • Peoria, Illinois, Spojené státy, 61637
        • Pozastaveno
        • OSF Saint Francis Medical Center
      • Peru, Illinois, Spojené státy, 61354
        • Pozastaveno
        • Valley Radiation Oncology
      • Peru, Illinois, Spojené státy, 61354
        • Pozastaveno
        • Illinois CancerCare-Peru
      • Princeton, Illinois, Spojené státy, 61356
        • Pozastaveno
        • Illinois CancerCare-Princeton
      • Springfield, Illinois, Spojené státy, 62702
        • Pozastaveno
        • Springfield Clinic
      • Springfield, Illinois, Spojené státy, 62702
        • Pozastaveno
        • Southern Illinois University School of Medicine
      • Springfield, Illinois, Spojené státy, 62781
        • Pozastaveno
        • Springfield Memorial Hospital
      • Washington, Illinois, Spojené státy, 61571
        • Pozastaveno
        • Illinois CancerCare - Washington
    • Iowa
      • Ankeny, Iowa, Spojené státy, 50023
        • Nábor
        • UI Health Care Mission Cancer and Blood - Ankeny Clinic
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 515-241-3305
        • Vrchní vyšetřovatel:
          • Seema Harichand-Herdt
      • Clive, Iowa, Spojené státy, 50325
        • Nábor
        • UI Health Care Mission Cancer and Blood - West Des Moines Clinic
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 515-241-3305
        • Vrchní vyšetřovatel:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Spojené státy, 50309
        • Nábor
        • UI Health Care Mission Cancer and Blood - Des Moines Clinic
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 515-241-3305
        • Vrchní vyšetřovatel:
          • Seema Harichand-Herdt
      • Des Moines, Iowa, Spojené státy, 50314
        • Nábor
        • UI Health Care Mission Cancer and Blood - Laurel Clinic
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 515-241-3305
        • Vrchní vyšetřovatel:
          • Seema Harichand-Herdt
      • Waukee, Iowa, Spojené státy, 50263
        • Nábor
        • UI Health Care Mission Cancer and Blood - Waukee Clinic
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 515-241-3305
        • Vrchní vyšetřovatel:
          • Seema Harichand-Herdt
    • Kansas
      • Garden City, Kansas, Spojené státy, 67846
        • Pozastaveno
        • Central Care Cancer Center - Garden City
      • Great Bend, Kansas, Spojené státy, 67530
        • Pozastaveno
        • Central Care Cancer Center - Great Bend
      • Kansas City, Kansas, Spojené státy, 66160
        • Nábor
        • University of Kansas Cancer Center
        • Vrchní vyšetřovatel:
          • Kenneth Byrd
        • Kontakt:
      • Westwood, Kansas, Spojené státy, 66205
        • Nábor
        • University of Kansas Hospital-Westwood Cancer Center
        • Vrchní vyšetřovatel:
          • Kenneth Byrd
        • Kontakt:
    • Louisiana
      • New Orleans, Louisiana, Spojené státy, 70121
        • Aktivní, ne nábor
        • Ochsner Medical Center Jefferson
    • Maryland
      • Baltimore, Maryland, Spojené státy, 21201
        • Aktivní, ne nábor
        • University of Maryland/Greenebaum Cancer Center
    • Massachusetts
      • Springfield, Massachusetts, Spojené státy, 01104
        • Aktivní, ne nábor
        • Mercy Medical Center
    • Michigan
      • Ann Arbor, Michigan, Spojené státy, 48106
        • Nábor
        • Trinity Health Saint Joseph Mercy Hospital Ann Arbor
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
      • Brighton, Michigan, Spojené státy, 48114
        • Nábor
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
      • Brighton, Michigan, Spojené státy, 48114
        • Nábor
        • Trinity Health Medical Center - Brighton
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
      • Canton, Michigan, Spojené státy, 48188
        • Nábor
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
      • Canton, Michigan, Spojené státy, 48188
        • Nábor
        • Trinity Health Medical Center - Canton
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
      • Caro, Michigan, Spojené státy, 48723
        • Pozastaveno
        • Caro Cancer Center
      • Chelsea, Michigan, Spojené státy, 48118
        • Nábor
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
      • Chelsea, Michigan, Spojené státy, 48118
      • Clarkston, Michigan, Spojené státy, 48346
        • Pozastaveno
        • Hematology Oncology Consultants-Clarkston
      • Clarkston, Michigan, Spojené státy, 48346
        • Pozastaveno
        • Newland Medical Associates-Clarkston
      • Detroit, Michigan, Spojené státy, 48236
        • Nábor
        • Henry Ford Health Saint John Hospital
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
        • Kontakt:
      • East China Township, Michigan, Spojené státy, 48054
        • Nábor
        • Henry Ford River District Hospital
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
        • Kontakt:
      • Flint, Michigan, Spojené státy, 48503
        • Nábor
        • Genesys Hurley Cancer Institute
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
        • Kontakt:
      • Flint, Michigan, Spojené státy, 48503
        • Nábor
        • Hurley Medical Center
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
        • Kontakt:
      • Flint, Michigan, Spojené státy, 48503
        • Pozastaveno
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Spojené státy, 48503
        • Nábor
        • Cancer Hematology Centers - Flint
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
        • Kontakt:
      • Grosse Pointe Woods, Michigan, Spojené státy, 48236
        • Pozastaveno
        • Henry Ford Saint John Hospital - Breast
      • Grosse Pointe Woods, Michigan, Spojené státy, 48236
        • Nábor
        • Henry Ford Saint John Hospital - Academic
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
        • Kontakt:
      • Grosse Pointe Woods, Michigan, Spojené státy, 48236
        • Nábor
        • Henry Ford Saint John Hospital - Van Elslander
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
        • Kontakt:
      • Lansing, Michigan, Spojené státy, 48912
        • Pozastaveno
        • University of Michigan Health - Sparrow Lansing
      • Livonia, Michigan, Spojené státy, 48154
        • Pozastaveno
        • Hope Cancer Clinic
      • Livonia, Michigan, Spojené státy, 48154
        • Nábor
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
      • Macomb, Michigan, Spojené státy, 48044
        • Pozastaveno
        • Henry Ford Warren Hospital - Breast Macomb
      • Macomb, Michigan, Spojené státy, 48044
        • Nábor
        • Henry Ford Saint John Hospital - Macomb Medical
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
        • Kontakt:
      • Marlette, Michigan, Spojené státy, 48453
        • Pozastaveno
        • Saint Mary's Oncology/Hematology Associates of Marlette
      • Pontiac, Michigan, Spojené státy, 48341
        • Pozastaveno
        • Hope Cancer Center
      • Pontiac, Michigan, Spojené státy, 48341
        • Nábor
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
      • Pontiac, Michigan, Spojené státy, 48341
        • Pozastaveno
        • Michigan Healthcare Professionals Pontiac
      • Pontiac, Michigan, Spojené státy, 48341
        • Pozastaveno
        • Trinity Health IHA Medical Group-Alice Gustafson Center
      • Rochester Hills, Michigan, Spojené státy, 48309
        • Pozastaveno
        • Henry Ford Rochester Hospital
      • Saginaw, Michigan, Spojené státy, 48604
        • Pozastaveno
        • Oncology Hematology Associates of Saginaw Valley PC
      • Saginaw, Michigan, Spojené státy, 48601
        • Nábor
        • MyMichigan Medical Center Saginaw
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
      • Sterling Heights, Michigan, Spojené státy, 48312
        • Pozastaveno
        • Bhadresh Nayak MD PC-Sterling Heights
      • Tawas City, Michigan, Spojené státy, 48764
        • Nábor
        • MyMichigan Medical Center Tawas
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
      • Warren, Michigan, Spojené státy, 48088
        • Pozastaveno
        • Advanced Breast Care Center PLLC
      • Warren, Michigan, Spojené státy, 48093
        • Pozastaveno
        • Macomb Hematology Oncology PC
      • Warren, Michigan, Spojené státy, 48093
        • Pozastaveno
        • Henry Ford Madison Heights Hospital - Breast
      • Warren, Michigan, Spojené státy, 48093
        • Nábor
        • Henry Ford Health Warren Hospital
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
        • Kontakt:
      • Warren, Michigan, Spojené státy, 48093
        • Nábor
        • Henry Ford Warren Hospital - GLCMS
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
        • Kontakt:
      • West Branch, Michigan, Spojené státy, 48661
        • Pozastaveno
        • Saint Mary's Oncology/Hematology Associates of West Branch
      • Ypsilanti, Michigan, Spojené státy, 48106
      • Ypsilanti, Michigan, Spojené státy, 48197
        • Nábor
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Christopher M. Reynolds
    • Minnesota
      • Rochester, Minnesota, Spojené státy, 55905
        • Dokončeno
        • Mayo Clinic in Rochester
    • Missouri
      • Ballwin, Missouri, Spojené státy, 63011
        • Pozastaveno
        • Mercy Oncology and Hematology - Clayton-Clarkson
      • Bolivar, Missouri, Spojené státy, 65613
        • Pozastaveno
        • Central Care Cancer Center - Bolivar
      • Branson, Missouri, Spojené státy, 65616
        • Pozastaveno
        • Cox Cancer Center Branson
      • Cape Girardeau, Missouri, Spojené státy, 63703
        • Pozastaveno
        • Saint Francis Medical Center
      • Cape Girardeau, Missouri, Spojené státy, 63703
        • Pozastaveno
        • Mercy Cancer Center - Cape Girardeau
      • City of Saint Peters, Missouri, Spojené státy, 63376
        • Nábor
        • Siteman Cancer Center at Saint Peters Hospital
        • Vrchní vyšetřovatel:
          • Geoffrey L. Uy
        • Kontakt:
      • Creve Coeur, Missouri, Spojené státy, 63141
        • Nábor
        • Siteman Cancer Center at West County Hospital
        • Vrchní vyšetřovatel:
          • Geoffrey L. Uy
        • Kontakt:
      • Farmington, Missouri, Spojené státy, 63640
        • Pozastaveno
        • Parkland Health Center - Farmington
      • Jefferson City, Missouri, Spojené státy, 65109
        • Pozastaveno
        • MU Health Care Goldschmidt Cancer Center
      • Joplin, Missouri, Spojené státy, 64804
        • Pozastaveno
        • Freeman Health System
      • Joplin, Missouri, Spojené státy, 64804
        • Pozastaveno
        • Mercy Hospital Joplin
      • Rolla, Missouri, Spojené státy, 65401
        • Pozastaveno
        • Mercy Clinic-Rolla-Cancer and Hematology
      • Rolla, Missouri, Spojené státy, 65401
        • Pozastaveno
        • Phelps Health Delbert Day Cancer Institute
      • Saint Joseph, Missouri, Spojené státy, 64506
        • Pozastaveno
        • Heartland Regional Medical Center
      • Sainte Genevieve, Missouri, Spojené státy, 63670
        • Pozastaveno
        • Sainte Genevieve County Memorial Hospital
      • Springfield, Missouri, Spojené státy, 65804
        • Pozastaveno
        • Mercy Hospital Springfield
      • Springfield, Missouri, Spojené státy, 65807
        • Pozastaveno
        • CoxHealth South Hospital
      • St Louis, Missouri, Spojené státy, 63110
        • Nábor
        • Washington University School of Medicine
        • Vrchní vyšetřovatel:
          • Geoffrey L. Uy
        • Kontakt:
      • St Louis, Missouri, Spojené státy, 63128
        • Nábor
        • Mercy Hospital South
        • Vrchní vyšetřovatel:
          • Jay W. Carlson
        • Kontakt:
      • St Louis, Missouri, Spojené státy, 63141
        • Nábor
        • Mercy Hospital Saint Louis
        • Vrchní vyšetřovatel:
          • Jay W. Carlson
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 314-251-7066
      • St Louis, Missouri, Spojené státy, 63129
        • Nábor
        • Siteman Cancer Center-South County
        • Vrchní vyšetřovatel:
          • Geoffrey L. Uy
        • Kontakt:
      • St Louis, Missouri, Spojené státy, 63136
        • Nábor
        • Siteman Cancer Center at Christian Hospital
        • Vrchní vyšetřovatel:
          • Geoffrey L. Uy
        • Kontakt:
      • St Louis, Missouri, Spojené státy, 63109
        • Pozastaveno
        • Mercy Infusion Center - Chippewa
      • St Louis, Missouri, Spojené státy, 63131
        • Pozastaveno
        • Missouri Baptist Medical Center
      • Sullivan, Missouri, Spojené státy, 63080
        • Pozastaveno
        • Missouri Baptist Sullivan Hospital
      • Washington, Missouri, Spojené státy, 63090
        • Pozastaveno
        • Mercy Hospital Washington
    • Montana
      • Missoula, Montana, Spojené státy, 59802
        • Pozastaveno
        • Saint Patrick Hospital - Community Hospital
    • Nebraska
      • Omaha, Nebraska, Spojené státy, 68198
        • Aktivní, ne nábor
        • University of Nebraska Medical Center
      • Omaha, Nebraska, Spojené státy, 68118
        • Aktivní, ne nábor
        • Nebraska Medicine-Village Pointe
    • Nevada
      • Carson City, Nevada, Spojené státy, 89703
        • Pozastaveno
        • Carson Tahoe Regional Medical Center
      • Henderson, Nevada, Spojené státy, 89052
        • Pozastaveno
        • Cancer and Blood Specialists-Henderson
      • Henderson, Nevada, Spojené státy, 89052
        • Pozastaveno
        • Comprehensive Cancer Centers of Nevada - Henderson
      • Henderson, Nevada, Spojené státy, 89052
        • Pozastaveno
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
      • Henderson, Nevada, Spojené státy, 89052
        • Pozastaveno
        • Las Vegas Cancer Center-Henderson
      • Henderson, Nevada, Spojené státy, 89074
        • Pozastaveno
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
      • Henderson, Nevada, Spojené státy, 89074
        • Pozastaveno
        • Las Vegas Urology - Green Valley
      • Henderson, Nevada, Spojené státy, 89074
        • Pozastaveno
        • Las Vegas Urology - Pebble
      • Henderson, Nevada, Spojené státy, 89074
        • Pozastaveno
        • Urology Specialists of Nevada - Green Valley
      • Henderson, Nevada, Spojené státy, 89074
        • Pozastaveno
        • Oncology Las Vegas - Henderson
      • Las Vegas, Nevada, Spojené státy, 89102
        • Pozastaveno
        • Desert West Surgery
      • Las Vegas, Nevada, Spojené státy, 89109
        • Pozastaveno
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, Spojené státy, 89113
        • Pozastaveno
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, Spojené státy, 89128
        • Pozastaveno
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, Spojené státy, 89149
        • Pozastaveno
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, Spojené státy, 89074
        • Pozastaveno
        • Las Vegas Urology - Pecos
      • Las Vegas, Nevada, Spojené státy, 89102
        • Pozastaveno
        • University Medical Center of Southern Nevada
      • Las Vegas, Nevada, Spojené státy, 89103
        • Pozastaveno
        • Hope Cancer Care of Nevada
      • Las Vegas, Nevada, Spojené státy, 89106
        • Pozastaveno
        • Radiation Oncology Centers of Nevada Central
      • Las Vegas, Nevada, Spojené státy, 89106
        • Pozastaveno
        • Urology Specialists of Nevada - Central
      • Las Vegas, Nevada, Spojené státy, 89109
        • Pozastaveno
        • Sunrise Hospital and Medical Center
      • Las Vegas, Nevada, Spojené státy, 89113
        • Pozastaveno
        • Las Vegas Prostate Cancer Center
      • Las Vegas, Nevada, Spojené státy, 89113
        • Pozastaveno
        • Las Vegas Urology - Sunset
      • Las Vegas, Nevada, Spojené státy, 89113
        • Pozastaveno
        • Urology Specialists of Nevada - Southwest
      • Las Vegas, Nevada, Spojené státy, 89119
        • Pozastaveno
        • Radiation Oncology Centers of Nevada Southeast
      • Las Vegas, Nevada, Spojené státy, 89128
        • Pozastaveno
        • Ann M Wierman MD LTD
      • Las Vegas, Nevada, Spojené státy, 89128
        • Pozastaveno
        • Comprehensive Cancer Centers of Nevada - Northwest
      • Las Vegas, Nevada, Spojené státy, 89128
        • Pozastaveno
        • Las Vegas Urology - Cathedral Rock
      • Las Vegas, Nevada, Spojené státy, 89128
        • Pozastaveno
        • Las Vegas Urology - Smoke Ranch
      • Las Vegas, Nevada, Spojené státy, 89128
        • Pozastaveno
        • OptumCare Cancer Care at MountainView
      • Las Vegas, Nevada, Spojené státy, 89128
        • Pozastaveno
        • Urology Specialists of Nevada - Northwest
      • Las Vegas, Nevada, Spojené státy, 89135
        • Pozastaveno
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
      • Las Vegas, Nevada, Spojené státy, 89144
        • Pozastaveno
        • Comprehensive Cancer Centers of Nevada - Town Center
      • Las Vegas, Nevada, Spojené státy, 89144
        • Pozastaveno
        • Comprehensive Cancer Centers of Nevada-Summerlin
      • Las Vegas, Nevada, Spojené státy, 89144
        • Pozastaveno
        • Summerlin Hospital Medical Center
      • Las Vegas, Nevada, Spojené státy, 89148-2405
        • Pozastaveno
        • Las Vegas Cancer Center-Medical Center
      • Las Vegas, Nevada, Spojené státy, 89148
        • Pozastaveno
        • Comprehensive Cancer Centers of Nevada
      • Las Vegas, Nevada, Spojené státy, 89169
        • Pozastaveno
        • Comprehensive Cancer Centers of Nevada - Central Valley
      • Las Vegas, Nevada, Spojené státy, 89169
        • Pozastaveno
        • University Cancer Center
      • Las Vegas, Nevada, Spojené státy, 89102
        • Pozastaveno
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Spojené státy, 89128
        • Pozastaveno
        • Oncology Las Vegas - Tenaya
      • Las Vegas, Nevada, Spojené státy, 89183
        • Pozastaveno
        • OptumCare Cancer Care at Fort Apache
      • Pahrump, Nevada, Spojené státy, 89048
        • Pozastaveno
        • Hope Cancer Care of Nevada-Pahrump
      • Reno, Nevada, Spojené státy, 89502
        • Pozastaveno
        • Renown Regional Medical Center
      • Reno, Nevada, Spojené státy, 89503
        • Pozastaveno
        • Saint Mary's Regional Medical Center
      • Reno, Nevada, Spojené státy, 89509
        • Pozastaveno
        • Radiation Oncology Associates
    • New York
      • Buffalo, New York, Spojené státy, 14263
        • Aktivní, ne nábor
        • Roswell Park Cancer Institute
      • Lake Success, New York, Spojené státy, 11042
        • Nábor
        • Northwell Health/Center for Advanced Medicine
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 516-734-8896
        • Vrchní vyšetřovatel:
          • Bradley H. Goldberg
      • Manhasset, New York, Spojené státy, 11030
        • Nábor
        • North Shore University Hospital
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 516-734-8896
        • Vrchní vyšetřovatel:
          • Bradley H. Goldberg
      • New Hyde Park, New York, Spojené státy, 11040
        • Nábor
        • Long Island Jewish Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 516-734-8896
        • Vrchní vyšetřovatel:
          • Bradley H. Goldberg
      • New York, New York, Spojené státy, 10065
        • Aktivní, ne nábor
        • NYP/Weill Cornell Medical Center
      • Rochester, New York, Spojené státy, 14642
        • Nábor
        • University of Rochester
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 585-275-5830
        • Vrchní vyšetřovatel:
          • Kristen M. O'Dwyer
      • Stony Brook, New York, Spojené státy, 11794
        • Nábor
        • Stony Brook University Medical Center
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 800-862-2215
        • Vrchní vyšetřovatel:
          • Suhu Liu
    • North Carolina
      • Chapel Hill, North Carolina, Spojené státy, 27599
        • Pozastaveno
        • UNC Lineberger Comprehensive Cancer Center
      • Durham, North Carolina, Spojené státy, 27710
        • Aktivní, ne nábor
        • Duke University Medical Center
      • Greenville, North Carolina, Spojené státy, 27834
        • Pozastaveno
        • East Carolina University
      • Winston-Salem, North Carolina, Spojené státy, 27157
        • Nábor
        • Wake Forest University Health Sciences
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 336-713-6771
        • Vrchní vyšetřovatel:
          • Bayard L. Powell
    • Ohio
      • Cincinnati, Ohio, Spojené státy, 45219
        • Nábor
        • University of Cincinnati Cancer Center-UC Medical Center
        • Vrchní vyšetřovatel:
          • Emily K. Curran
        • Kontakt:
      • Columbus, Ohio, Spojené státy, 43210
        • Nábor
        • Ohio State University Comprehensive Cancer Center
        • Vrchní vyšetřovatel:
          • Gregory K. Behbehani
        • Kontakt:
      • West Chester, Ohio, Spojené státy, 45069
        • Nábor
        • University of Cincinnati Cancer Center-West Chester
        • Vrchní vyšetřovatel:
          • Emily K. Curran
        • Kontakt:
    • Oklahoma
      • Oklahoma City, Oklahoma, Spojené státy, 73104
        • Nábor
        • University of Oklahoma Health Sciences Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Zimu Gong
      • Oklahoma City, Oklahoma, Spojené státy, 73120
        • Pozastaveno
        • Mercy Hospital Oklahoma City
    • Oregon
      • Bend, Oregon, Spojené státy, 97701
        • Pozastaveno
        • Saint Charles Health System
      • Clackamas, Oregon, Spojené státy, 97015
        • Nábor
        • Clackamas Radiation Oncology Center
        • Vrchní vyšetřovatel:
          • Alison K. Conlin
        • Kontakt:
      • Clackamas, Oregon, Spojené státy, 97015
        • Pozastaveno
        • Providence Cancer Institute Clackamas Clinic
      • Coos Bay, Oregon, Spojené státy, 97420
        • Pozastaveno
        • Bay Area Hospital
      • Newberg, Oregon, Spojené státy, 97132
        • Nábor
        • Providence Newberg Medical Center
        • Vrchní vyšetřovatel:
          • Alison K. Conlin
        • Kontakt:
      • Oregon City, Oregon, Spojené státy, 97045
        • Nábor
        • Providence Willamette Falls Medical Center
        • Vrchní vyšetřovatel:
          • Alison K. Conlin
        • Kontakt:
      • Portland, Oregon, Spojené státy, 97213
        • Nábor
        • Providence Portland Medical Center
        • Vrchní vyšetřovatel:
          • Alison K. Conlin
        • Kontakt:
      • Portland, Oregon, Spojené státy, 97225
        • Nábor
        • Providence Saint Vincent Medical Center
        • Vrchní vyšetřovatel:
          • Alison K. Conlin
        • Kontakt:
      • Portland, Oregon, Spojené státy, 97239
        • Aktivní, ne nábor
        • Oregon Health and Science University
      • Redmond, Oregon, Spojené státy, 97756
        • Pozastaveno
        • Saint Charles Health System-Redmond
    • Pennsylvania
      • Allentown, Pennsylvania, Spojené státy, 18103
        • Pozastaveno
        • Lehigh Valley Hospital-Cedar Crest
      • Bethlehem, Pennsylvania, Spojené státy, 18017
        • Pozastaveno
        • Lehigh Valley Hospital - Muhlenberg
      • Chadds Ford, Pennsylvania, Spojené státy, 19317
        • Pozastaveno
        • Christiana Care Health System-Concord Health Center
      • East Stroudsburg, Pennsylvania, Spojené státy, 18301
        • Pozastaveno
        • Pocono Medical Center
      • Hazleton, Pennsylvania, Spojené státy, 18201
        • Pozastaveno
        • Lehigh Valley Hospital-Hazleton
      • Philadelphia, Pennsylvania, Spojené státy, 19107
        • Aktivní, ne nábor
        • Thomas Jefferson University Hospital
    • Virginia
      • Richmond, Virginia, Spojené státy, 23298
        • Nábor
        • VCU Massey Comprehensive Cancer Center
        • Vrchní vyšetřovatel:
          • Keri R. Maher
        • Kontakt:
    • Washington
      • Aberdeen, Washington, Spojené státy, 98520
        • Pozastaveno
        • Providence Regional Cancer System-Aberdeen
      • Bellevue, Washington, Spojené státy, 98004
        • Pozastaveno
        • Overlake Medical Center
      • Bellingham, Washington, Spojené státy, 98225
        • Pozastaveno
        • PeaceHealth Saint Joseph Medical Center
      • Centralia, Washington, Spojené státy, 98531
        • Pozastaveno
        • Providence Regional Cancer System-Centralia
      • Edmonds, Washington, Spojené státy, 98026
        • Pozastaveno
        • Swedish Cancer Institute-Edmonds
      • Everett, Washington, Spojené státy, 98201
        • Pozastaveno
        • Providence Regional Cancer Partnership
      • Issaquah, Washington, Spojené státy, 98029
        • Pozastaveno
        • Swedish Cancer Institute-Issaquah
      • Kennewick, Washington, Spojené státy, 99336
        • Pozastaveno
        • Kadlec Clinic Hematology and Oncology
      • Lacey, Washington, Spojené státy, 98503
        • Pozastaveno
        • Providence Regional Cancer System-Lacey
      • Longview, Washington, Spojené státy, 98632
        • Pozastaveno
        • PeaceHealth Saint John Medical Center
      • Renton, Washington, Spojené státy, 98055
        • Pozastaveno
        • Valley Medical Center
      • Seattle, Washington, Spojené státy, 98104
        • Pozastaveno
        • Pacific Gynecology Specialists
      • Seattle, Washington, Spojené státy, 98107
        • Pozastaveno
        • Swedish Medical Center-Ballard Campus
      • Seattle, Washington, Spojené státy, 98122-5711
        • Pozastaveno
        • Swedish Medical Center-Cherry Hill
      • Seattle, Washington, Spojené státy, 98122
        • Pozastaveno
        • Swedish Medical Center-First Hill
      • Sedro-Woolley, Washington, Spojené státy, 98284
        • Pozastaveno
        • PeaceHealth United General Medical Center
      • Shelton, Washington, Spojené státy, 98584
        • Pozastaveno
        • Providence Regional Cancer System-Shelton
      • Vancouver, Washington, Spojené státy, 98664
        • Pozastaveno
        • PeaceHealth Southwest Medical Center
      • Walla Walla, Washington, Spojené státy, 99362
        • Pozastaveno
        • Providence Saint Mary Regional Cancer Center
      • Yakima, Washington, Spojené státy, 98902
        • Pozastaveno
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
      • Yelm, Washington, Spojené státy, 98597
        • Pozastaveno
        • Providence Regional Cancer System-Yelm
    • West Virginia
      • Morgantown, West Virginia, Spojené státy, 26506
        • Aktivní, ne nábor
        • West Virginia University Healthcare
    • Wisconsin
      • Eau Claire, Wisconsin, Spojené státy, 54701
      • Madison, Wisconsin, Spojené státy, 53792
        • Aktivní, ne nábor
        • University of Wisconsin Carbone Cancer Center - University Hospital
      • Madison, Wisconsin, Spojené státy, 53718
        • Aktivní, ne nábor
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
      • Marshfield, Wisconsin, Spojené státy, 54449
      • Menomonee Falls, Wisconsin, Spojené státy, 53051
        • Nábor
        • Froedtert Menomonee Falls Hospital
        • Vrchní vyšetřovatel:
          • Ehab L. Atallah
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 262-257-5100
      • Milwaukee, Wisconsin, Spojené státy, 53226
        • Nábor
        • Medical College of Wisconsin
        • Vrchní vyšetřovatel:
          • Ehab L. Atallah
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 414-805-3666
      • Minocqua, Wisconsin, Spojené státy, 54548
      • New Berlin, Wisconsin, Spojené státy, 53151
        • Nábor
        • Froedtert and MCW Moorland Reserve Health Center
        • Vrchní vyšetřovatel:
          • Ehab L. Atallah
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 414-805-0505
      • Oak Creek, Wisconsin, Spojené státy, 53154
        • Nábor
        • Drexel Town Square Health Center
        • Vrchní vyšetřovatel:
          • Ehab L. Atallah
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 414-805-0505
      • Rice Lake, Wisconsin, Spojené státy, 54868
      • Stevens Point, Wisconsin, Spojené státy, 54482
      • West Bend, Wisconsin, Spojené státy, 53095
        • Nábor
        • Froedtert West Bend Hospital/Kraemer Cancer Center
        • Vrchní vyšetřovatel:
          • Ehab L. Atallah
        • Kontakt:
          • Site Public Contact
          • Telefonní číslo: 414-805-0505
      • Weston, Wisconsin, Spojené státy, 54476

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • STEP 0: Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration. The specimens should be sent to the HEME Biobank.

    • Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate:

      • Patients may receive the day 1 of course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy.

  • STEP 1: Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on World Health Organization (WHO) criteria. Patients with Burkitt lymphoma/leukemia are not eligible.

  • STEP 1: CD22-positive disease defined as CD22 expression by >= 20% of lymphoblasts by local hematopathology evaluation.

  • STEP 1: Philadelphia chromosome/BCR-ABL1-negative or Philadelphia chromosome/BCR-ABL1-positive B-cell ALL by cytogenetics, fluorescence in situ hybridization (FISH), and/or polymerase chain reaction (PCR).

  • STEP 1: No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and/or known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion.

    • Categories of CNS Involvement for CNS Evaluation Prior to Registration:

      • CNS 1: CSF has < 5 WBC/uL with cytospin negative for blasts; or >= 10 red blood cell (RBC)/uL with cytospin negative for blasts.

      • CNS 2: CSF has < 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, WBC/uL >= 5 but less than Steinherz/Bleyer algorithm with cytospin positive for blasts (see below).

      • CNS 3: CSF has >= 5 WBC/uL with cytospin positive for blasts; or >= 10 RBC/uL, >= 5 WBC/uL and positive by Steinherz/Bleyer algorithm (see below); or clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome). Steinherz/Bleyer Method of Evaluating Initial Traumatic Lumbar Punctures:

        • If the patient has leukemia cells in the peripheral blood and the lumbar puncture is traumatic and contains >= 5 WBC/uL with blasts, the following algorithm should be used to define CNS disease: CSF WBC/CSF RBC > 2 x (Blood WBC/Blood RBC count)

  • STEP 1: Patients with known or suspected testicular involvement by leukemia are allowed provided that the patient receives concomitant scrotal/testicular radiotherapy.

    • Unilateral or bilateral testicular enlargement should be assessed by ultrasound or other imaging technique. Biopsy is recommended if clinical findings are equivocal or suggestive of hydrocele or a non-leukemic mass, but further assessments are per treating physician discretion.

  • STEP 1: Not pregnant and not nursing.

    • This study involves agents that have known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =< 7 days prior to registration is required.

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

  • STEP 1: No unstable cardiac disease such as myocardial infarction, angina pectoris, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months of registration.

  • STEP 1: No impaired cardiac function, defined as left ventricular ejection fraction (LVEF) < 45% or New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF).

  • STEP 1: Patients with known human immunodeficiency virus (HIV) infection are eligible if they have been on effective antiretroviral therapy with an undetectable viral load tested within 6 months of registration.

  • STEP 1: Patients with hepatitis B virus (HBV) are eligible only if they meet all the following:

    • On HBV-suppressive therapy.
    • No evidence of active virus.
    • No evidence of HBV-related liver damage.

  • STEP 1: Patients with hepatitis C virus (HCV) are eligible only if they meet all the following:

    • Successfully completed complete-eradication therapy with undetectable viral load.
    • No evidence of HCV-related liver damage.

  • STEP 1: No history of clinically relevant neurologic disorder such as epilepsy, seizure, aphasia, stroke, severe brain injury, structural brain abnormality, benign brain tumor, dementia, Parkinson's disease, movement disorder, cerebellar disease, or other significant CNS abnormalities.

  • STEP 1: No prior additional malignancy (i.e. in addition to ALL) except adequately treated basal- or squamous-cell skin cancer, in situ cervical cancer, stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for >= 2 years.

  • STEP 1: No history of clinically significant ventricular arrhythmia, unexplained non-vasovagal syncope, or chronic bradycardic states such as sinoatrial block or higher degree of atrioventricular block unless a permanent pacemaker has been implanted.

  • STEP 1: No history of chronic liver disease, including cirrhosis.

  • STEP 1: No history of sinusoidal occlusion syndrome/veno-occlusive disease of the liver.

  • STEP 1: No uncontrolled infection or recent history (within 4 months prior to registration) of deep tissue infections such as fasciitis or osteomyelitis.

  • STEP 1: Total bilirubin, serum =< 1.5 x upper limit of normal (ULN)*

    • Except in the event of: 1) Gilbert disease, in which case total bilirubin must be =< 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be =< 2 x ULN.

  • STEP 1: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 2.5 x ULN

  • STEP 1: Creatinine, serum =< 1.5 ULN OR creatinine clearance >= 40 mL/min

  • STEP 1: QT interval by Fridericia's correction formula (QTcF) =< 470 msec

  • COHORT 1: Age >= 60 years.

  • COHORT 1: Diagnosis of Philadelphia chromosome/BCR-ABL1-negative B-cell ALL.

  • COHORT 1: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed therapy may be administered for no more than 14 days and must be completed >= 24 hours prior to the initiation of protocol therapy.

  • COHORT 1: No plan for allogeneic or autologous hematopoietic cell transplantation (HCT).

  • COHORT 2: Age >= 18 years.

  • COHORT 2: Diagnosis of Philadelphia chromosome/BCR-ABL1-negative B-cell ALL.

  • COHORT 2: Relapsed or refractory disease in salvage 1 or 2.

  • COHORT 2: No isolated extramedullary relapse.

  • COHORT 2: Prior allogeneic HCT permitted.

  • COHORT 2: Patients with prior allogeneic HCT must have completed transplantation >= 4 months prior to registration.

  • COHORT 2: Patients with prior allogeneic HCT must have no evidence of graft-versus-host disease and must have completed immunosuppressive therapy >= 30 days prior to registration.

  • COHORT 2: Prior treatment with inotuzumab ozogamicin, blinatumomab, other CD22-directed therapy, or other CD19-directed therapy is not allowed.

  • COHORT 2: Prior treatment with rituximab must be completed >= 7 days prior to registration.

  • COHORT 2: Prior treatment with other monoclonal antibodies must be completed >= 6 weeks prior to registration.

  • COHORT 2: Prior treatment for ALL must be completed >= 14 days prior to registration with the following exceptions: intrathecal chemotherapy, hydroxyurea, corticosteroids, 6-mercaptopurine, methotrexate, vincristine, and/or leukapheresis to reduce circulating absolute lymphoblast count to =< 10,000/uL or prevent complications related to ALL are allowed but must be completed >= 24 hours prior to the initiation of protocol therapy.

  • COHORT 2: Patients should have resolution of any acute non-hematologic toxicities of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grade =< 1.

  • COHORT 2: Peripheral blood absolute lymphoblast count =< 10,000/uL (treatment allowed as above to reduce blast count to =< 10,000/uL)

  • COHORT 3: Age ≥ 75 years OR age ≥ 18 years AND ineligible for hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HyperCVAD) regimens

  • COHORT 3: Diagnosis of Philadelphia chromosome/BCR-ABL1-positive B-cell ALL

  • COHORT 3: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, BCR-ABL1-targeted tyrosine kinase inhibitor, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed non-protocol therapy may be administered for no more than 14 days and must be completed ≥ 24 hours prior to the initiation of protocol therapy.

  • COHORT 3: No chronic, strong CYP3A4 inducers

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Cohort 1 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description..
Postup: Bone Marrow Biopsy

Undergo bone marrow biopsy

Ostatní jména:
  • Biopsie kostní dřeně
  • Biopsie, kostní dřeň
Biologický: Blinatumomab

Given IV

Ostatní jména:
  • Blancyto
  • Bispecifická monoklonální protilátka anti-CD19 x anti-CD3
  • Rekombinantní bispecifická monoklonální protilátka MT103 anti-CD19/anti-CD3
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Postup: Lumbar Puncture

Undergo lumbar puncture

Ostatní jména:
  • LP
  • Spinální kohoutek
Biologický: Inotuzumab Ozogamicin

Given IV

Ostatní jména:
  • Besponsa
  • CMC-544
  • Cesta 207294
  • WAY-207294
  • CMC 544
  • CMC544
Postup: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Ostatní jména:
  • Sběr biologických vzorků
  • Odebrán biovzorek
  • Sbírka vzorků
Experimentální: Cohort 2 (inotuzumab ozogamicin, blinatumomab)

See Detailed Description.
Postup: Bone Marrow Biopsy

Undergo bone marrow biopsy

Ostatní jména:
  • Biopsie kostní dřeně
  • Biopsie, kostní dřeň
Biologický: Blinatumomab

Given IV

Ostatní jména:
  • Blancyto
  • Bispecifická monoklonální protilátka anti-CD19 x anti-CD3
  • Rekombinantní bispecifická monoklonální protilátka MT103 anti-CD19/anti-CD3
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Postup: Bone Marrow Aspiration

Undergo bone marrow aspiration

Postup: Lumbar Puncture

Undergo lumbar puncture

Ostatní jména:
  • LP
  • Spinální kohoutek
Biologický: Inotuzumab Ozogamicin

Given IV

Ostatní jména:
  • Besponsa
  • CMC-544
  • Cesta 207294
  • WAY-207294
  • CMC 544
  • CMC544
Postup: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Ostatní jména:
  • Sběr biologických vzorků
  • Odebrán biovzorek
  • Sbírka vzorků
Experimentální: Cohort 3 (inotuzumab ozogamicin, blinatumomab, ponatinib))

See detailed description
Postup: Bone Marrow Biopsy

Undergo bone marrow biopsy

Ostatní jména:
  • Biopsie kostní dřeně
  • Biopsie, kostní dřeň
Lék: Ponatinib

Given PO

Ostatní jména:
  • AP-24534
  • AP24534
  • AP 24534
Biologický: Blinatumomab

Given IV

Ostatní jména:
  • Blancyto
  • Bispecifická monoklonální protilátka anti-CD19 x anti-CD3
  • Rekombinantní bispecifická monoklonální protilátka MT103 anti-CD19/anti-CD3
  • MEDI-538
  • MT-103
  • AMG 103
  • MT103
  • AMG103
  • MEDI538
  • AMG-103
  • MEDI 538
  • MT 103
Postup: Bone Marrow Aspiration

Undergo bone marrow aspiration

Postup: Lumbar Puncture

Undergo lumbar puncture

Ostatní jména:
  • LP
  • Spinální kohoutek
Biologický: Inotuzumab Ozogamicin

Given IV

Ostatní jména:
  • Besponsa
  • CMC-544
  • Cesta 207294
  • WAY-207294
  • CMC 544
  • CMC544
Postup: Biospecimen Collection

Undergo blood sample and cerebrospinal fluid collection

Ostatní jména:
  • Sběr biologických vzorků
  • Odebrán biovzorek
  • Sbírka vzorků

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Event-free survival
Časové okno: At 1 year

Will be defined as time from start of treatment to failure to achieve complete response (CR)/complete response with incomplete count recovery (CRi) after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause
At 1 year
Completion of protocol treatment (cohort 3)
Časové okno: Up to 10 years

Feasibility defined as completion of the planned therapy as defined in the protocol. Success rate defined as the proportion of patients who either complete entire protocol treatment or go off protocol treatment due to the disease (e.g., refractory disease, progression, and relapse).
Up to 10 years

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Minimální negativita reziduální nemoci
Časové okno: Až 10 let
Až 10 let
Overall survival (OS)
Časové okno: Time from start of study therapy to death from any cause censored at the last known alive date, assessed up to 10 years

Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Time from start of study therapy to death from any cause censored at the last known alive date, assessed up to 10 years
Relapse-free survival (RFS)
Časové okno: Time from first CR/CRi to progressive disease (relapse, treatment discontinuation due to health deterioration) or death, assessed up to 10 years

Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Time from first CR/CRi to progressive disease (relapse, treatment discontinuation due to health deterioration) or death, assessed up to 10 years
Event-free survival (EFS)
Časové okno: Time from start of treatment to failure to achieve CR/CRi after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause, assessed up to 10 years

Will be evaluated using the Kaplan-Meier method. A 95% confidence interval for the 1- and 3-year rates will be constructed using a point-wise confidence interval for the survival function based on a log-minus-log transformation. Will also calculate a 95% confidence interval by using a point-wise confidence interval for the survival function based on a log-minus-log transformation.
Time from start of treatment to failure to achieve CR/CRi after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause, assessed up to 10 years
Complete and overall response rate
Časové okno: Up to 10 years

Point and interval estimates of the rates will be shown using a 95% binomial confidence interval.
Up to 10 years
Complete molecular response
Časové okno: Up to 10 years

Defined as negative BCR-ABL1 quantitative real time polymerase chain reaction on bone marrow aspirate in patients in CR/complete response with partial hematologic recovery/CRi.
Up to 10 years
Allogeneic hematopoietic cell transplantation rate (Cohort 2)
Časové okno: Up to 10 years

Point and interval estimates of the rate will be shown using a 95% binomial confidence interval.
Up to 10 years

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Rate of cytokine release syndrome (Cohort 1)
Časové okno: Up to 10 years

Point and interval estimates of the rate will be shown using a 95% binomial confidence interval.
Up to 10 years
Sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver
Časové okno: Up to 10 years

The rate of, timing of, and risk factors for SOS/VOD of the liver after limited inotuzumab ozogamicin exposure. Point and interval estimates of the rate will be shown using a 95% binomial confidence interval. A summary of the timing and risk factors for SOS/VOD of the liver will be provided.
Up to 10 years
OS
Časové okno: Up to 2 years

Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation versus (vs.) patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. The median, 1-year, and 2-year OS will be compared between the above two groups. The distribution of OS for each group will be estimated using the Kaplan-Meier method.
Up to 2 years
RFS
Časové okno: Up to 2 years

Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation vs. patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. The median, 1-year, and 2-year RFS will be compared between the above two groups. The distribution of RFS for each treatment arm will be estimated using the Kaplan-Meier method.
Up to 2 years
Cumulative incidence of relapse (CIR)
Časové okno: Up to 2 years

Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation vs. patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. Competing risk analysis will be done to compare the relapse rates between the above two groups. In this analysis, death will be considered a competing event. Relapse rates at the 1-year and 2-year time points will be estimated. Other time points of interest may be estimated as well.
Up to 2 years
Non-relapse mortality
Časové okno: Up to 2 years

Will compare between patients achieving CR/CRi and receiving consolidation with allogeneic hematopoietic cell transplantation vs. patients achieving CR/CRi and receiving consolidation without allogeneic hematopoietic cell transplantation. Competing risk analysis will be done to compare the mortality rates between the above two groups. In this analysis, relapse will be considered a competing event. Mortality rates at the 1-year and 2-year time points will be estimated. Other time points may be estimated as well.
Up to 2 years

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

National Cancer Institute (NCI)

Vyšetřovatelé

  • Vrchní vyšetřovatel: Matthew J Wieduwilt, Alliance for Clinical Trials in Oncology

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

8. května 2019

Primární dokončení (Odhadovaný)

1. února 2027

Dokončení studie (Odhadovaný)

1. února 2027

Termíny zápisu do studia

První předloženo

12. listopadu 2018

První předloženo, které splnilo kritéria kontroly kvality

12. listopadu 2018

První zveřejněno (Aktuální)

14. listopadu 2018

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

12. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. listopadu 2026

Naposledy ověřeno

1. srpna 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • NCI-2018-02484
  • U10CA180821 (Grant/smlouva NIH USA)
  • NCI-2018-02484 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
  • A041703 (Jiný identifikátor: CTEP)
  • A041703 (Jiný identifikátor: Alliance for Clinical Trials in Oncology)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit