- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02003222
Kombinationskemoterapi med eller utan Blinatumomab vid behandling av patienter med nyligen diagnostiserad BCR-ABL-negativ B-linje Akut lymfoblastisk leukemi
En randomiserad fas III-studie av Blinatumomab för nydiagnostiserad BCR-ABL-negativ B-linje Akut lymfoblastisk leukemi hos vuxna
This randomized phase III trial studies combination chemotherapy with blinatumomab to see how well it works compared to induction chemotherapy alone in treating patients with newly diagnosed breakpoint cluster region (BCR)-c-abl oncogene 1, non-receptor tyrosine kinase (ABL)-negative B lineage acute lymphoblastic leukemia. Drugs used in chemotherapy 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. Immunotherapy with monoclonal antibodies, such as blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known whether combination chemotherapy is more effective with or without blinatumomab in treating newly diagnosed acute lymphoblastic leukemia.
Studieöversikt
Status
Intervention / Behandling
- Läkemedel: Cyclophosphamide
- Läkemedel: Prednisone
- Procedur: Bone Marrow Biopsy
- Procedur: Biospecimen Collection
- Biologisk: Rituximab
- Läkemedel: Vincristine
- Läkemedel: Vincristine Sulfate
- Läkemedel: Dexamethasone
- Procedur: Allogeneic Hematopoietic Stem Cell Transplantation
- Biologisk: Blinatumomab
- Procedur: Bone Marrow Aspiration
- Läkemedel: Cytarabine
- Läkemedel: Daunorubicin
- Läkemedel: Daunorubicin Hydrochloride
- Läkemedel: Etoposide
- Läkemedel: Leucovorin Calcium
- Procedur: Lumbar Puncture
- Läkemedel: Mercaptopurine
- Läkemedel: Methotrexate
- Läkemedel: Pegaspargase
- Procedur: X-Ray Imaging
Detaljerad beskrivning
PRIMARY OBJECTIVE:
I. To compare the overall survival (OS) of blinatumomab in conjunction with chemotherapy to chemotherapy alone in patients with BCR-ABL-negative B cell precursor acute lymphoblastic leukemia (ALL) who are minimal residual disease (MRD) negative after induction and intensification chemotherapy, based on multiparameter flow cytometric (MFC) assessment of residual blasts.
SECONDARY OBJECTIVES:
I. To compare the relapse-free survival (RFS) of blinatumomab in conjunction with chemotherapy to chemotherapy alone in MRD negative patients after induction and intensification chemotherapy.
II. To compare the OS and RFS of those patients who are MRD positive (+) at step 3 randomization/registration and then convert to MRD negative (-) after 2 cycles of blinatumomab to those patients who are MRD- at randomization and remain MRD- after 2 cycles of blinatumomab or consolidation chemotherapy.
III. To assess the toxicities of blinatumomab in this patient population. IV. To assess the toxicities of the modified E2993 chemotherapy regimen in this patient population.
V. To describe the outcome of patients who proceed to allogeneic blood or marrow transplant after treatment with or without blinatumomab.
LABORATORY OBJECTIVES:
I. To determine differences in MRD kinetics among patients with the BCR/ABL1-like B-lineage ALL, and to compare the OS (and RFS) of patients with BCR-ABL-like phenotype with those without BCR-ABL-like phenotype.
II. To evaluate the incidence of anti-blinatumomab antibody formation.
OUTLINE:
INDUCTION CHEMOTHERAPY: Patients receive cytarabine intrathecally (IT) on day 1; daunorubicin hydrochloride intravenously (IV) over 10-15 minutes on days 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone orally (PO) daily on days 1-7 (and 15-21 for patients age < 55 years only); methotrexate IT on day 14; pegaspargase intramuscularly (IM) or IV on day 18 (patients age < 55 years); and CD20 positive patients may optionally receive rituximab IV on day 8 and 15. Beginning on day 29, patients with absolute neutrophil count (ANC) >= 0.75 x 10^9/L and platelets > 75 x 10^9/L (patients with delayed hematologic recovery) (patients with residual disease that is delaying count begin treatment immediately) receive cyclophosphamide IV over 30 minutes on days 1 and 29, cytarabine IV over 30 minutes or subcutaneously (SC) on days 1-4, 8-11, 29-32, and 36-39, mercaptopurine PO on days 1-14, 29-42, pegaspargase IM or IV on day 15 (patients age < 55 years), patients receiving treatment for central nervous system (CNS) 2 or 3 leukemia in cycle 1 receive methotrexate IT on days 1, 8, 15, and 22, and CD20 positive patients may optionally receive rituximab IV on days 8 and 15.
INTENSIFICATION THERAPY: Beginning 4 weeks after the completion of cycle 2 of induction therapy, patients receive intensification therapy comprising high-dose methotrexate IV over 2 hours on days 1 and 8, and pegaspargase IM or IV on day 9.
Patients are then randomized to 1 of 2 treatment arms.
Patients randomized to the blinatumomab group receive blinatumomab IV continuously on days 1-28. Treatment repeats every 6 weeks for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients may then undergo allogeneic stem cell transplant (SCT) or proceed to consolidation therapy per investigator discretion.
CONSOLIDATION THERAPY: Beginning after the second cycle of blinatumomab (patients randomized to the blinatumomab group) or after intensification therapy (patients not randomized to blinatumomab), patients receive cytarabine IV over 30 minutes or SC on days 1-5, etoposide IV over 1 hour on days 1-5, methotrexate IT on day 1, and pegaspargase IM or IV on day 5, and CD20 positive patients may optionally receive rituximab IV on day 5. Beginning 4 weeks from day 1 of cycle 1, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may receive rituximab as in cycle 1. Beginning 4 weeks from day 1 of cycle 2, patients receive daunorubicin hydrochloride IV over 10-15 minutes on day 1, 8, 15, and 22; vincristine sulfate IV on days 1, 8, 15, and 22; dexamethasone PO daily on days 1-7 (and 15-21 for patients age < 55 years); methotrexate IT on day 2; cyclophosphamide IV over 30 minutes on day 29; cytarabine IV over 30 minutes or SC on days 30-33 and 37-40; mercaptopurine PO on days 29-42 and CD20 positive patients may receive rituximab on day 8. Beginning 8 weeks from day 1 of cycle 3, patients receive cytarabine, etoposide, methotrexate, and CD20 positive patients may optionally receive rituximab as in cycle 1. Patients randomized to blinatumomab repeat cycle 4 and then receive blinatumomab IV continuously on days 1-28.
MAINTENANCE THERAPY: Within 6 weeks after beginning last cycle of consolidation therapy, patients receive mercaptopurine PO daily, methotrexate PO or IV over 2 hours once weekly for 2.5 years, vincristine sulfate IV on day 1 every 3 months, prednisone PO on days 1-5 every 3 months, and methotrexate IT on day 1 every 3 months. Treatment continues for up to 2.5 years in the absence of disease progression or unacceptable toxicity.
Patients undergo x-ray imaging during screening, lumbar puncture while on study, and bone marrow aspiration, bone marrow biopsy, and blood sample collection throughout the study.
After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then every 12 months for 5 years.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
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Alabama
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Birmingham, Alabama, Förenta staterna, 35233
- University of Alabama at Birmingham Cancer Center
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Alaska
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Anchorage, Alaska, Förenta staterna, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Förenta staterna, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Förenta staterna, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Förenta staterna, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, Förenta staterna, 99504
- Anchorage Radiation Therapy Center
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Anchorage, Alaska, Förenta staterna, 99508
- Alaska Regional Hospital
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Fairbanks, Alaska, Förenta staterna, 99701
- Fairbanks Memorial Hospital
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Arizona
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Kingman, Arizona, Förenta staterna, 86401
- Kingman Regional Medical Center
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Tucson, Arizona, Förenta staterna, 85719
- Banner University Medical Center - Tucson
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Tucson, Arizona, Förenta staterna, 85719
- University of Arizona Cancer Center-North Campus
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Arkansas
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Fort Smith, Arkansas, Förenta staterna, 72903
- Mercy Hospital Fort Smith
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Little Rock, Arkansas, Förenta staterna, 72205
- University of Arkansas for Medical Sciences
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California
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Arroyo Grande, California, Förenta staterna, 93420
- PCR Oncology
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Burbank, California, Förenta staterna, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Clovis, California, Förenta staterna, 93611
- Community Cancer Institute
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Clovis, California, Förenta staterna, 93611
- University Oncology Associates
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La Jolla, California, Förenta staterna, 92093
- UC San Diego Moores Cancer Center
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Orange, California, Förenta staterna, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Palo Alto, California, Förenta staterna, 94304
- Stanford Cancer Institute Palo Alto
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Colorado
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Aurora, Colorado, Förenta staterna, 80012
- Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, Förenta staterna, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Förenta staterna, 80303
- Boulder Community Foothills Hospital
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Boulder, Colorado, Förenta staterna, 80304
- Rocky Mountain Cancer Centers-Boulder
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Denver, Colorado, Förenta staterna, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Förenta staterna, 80220
- Rose Medical Center
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Denver, Colorado, Förenta staterna, 80218
- Rocky Mountain Cancer Centers-Midtown
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Denver, Colorado, Förenta staterna, 80220
- Rocky Mountain Cancer Centers-Rose
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Denver, Colorado, Förenta staterna, 80218
- Colorado Blood Cancer Institute
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Denver, Colorado, Förenta staterna, 80204
- Cancer Center of Colorado at Sloan's Lake
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Denver, Colorado, Förenta staterna, 80209
- The Women's Imaging Center
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Denver, Colorado, Förenta staterna, 80206
- National Jewish Health-Main Campus
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Denver, Colorado, Förenta staterna, 80220
- Western Surgical Care
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Denver, Colorado, Förenta staterna, 80218
- Saint Joseph Hospital - Cancer Centers of Colorado
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Englewood, Colorado, Förenta staterna, 80113
- Mountain Blue Cancer Care Center - Swedish
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Englewood, Colorado, Förenta staterna, 80113
- Swedish Medical Center
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Golden, Colorado, Förenta staterna, 80401
- National Jewish Health-Western Hematology Oncology
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Grand Junction, Colorado, Förenta staterna, 81501
- Saint Mary's Hospital and Regional Medical Center
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Grand Junction, Colorado, Förenta staterna, 81505
- Grand Valley Oncology
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Greeley, Colorado, Förenta staterna, 80631
- Banner North Colorado Medical Center
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Lafayette, Colorado, Förenta staterna, 80026
- Good Samaritan Hospital - Cancer Centers of Colorado
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Littleton, Colorado, Förenta staterna, 80120
- Rocky Mountain Cancer Centers-Littleton
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Lone Tree, Colorado, Förenta staterna, 80124
- Sky Ridge Medical Center
-
Lone Tree, Colorado, Förenta staterna, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Loveland, Colorado, Förenta staterna, 80539
- Banner North Colorado Medical Center - Loveland Campus
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Thornton, Colorado, Förenta staterna, 80260
- National Jewish Health-Northern Hematology Oncology
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Wheat Ridge, Colorado, Förenta staterna, 80401
- Intermountain Health Lutheran Hospital
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Connecticut
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Hartford, Connecticut, Förenta staterna, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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New Haven, Connecticut, Förenta staterna, 06520
- Yale University
-
Torrington, Connecticut, Förenta staterna, 06790
- Smilow Cancer Hospital-Torrington Care Center
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District of Columbia
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Washington D.C., District of Columbia, Förenta staterna, 20016
- Sibley Memorial Hospital
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Florida
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Coral Springs, Florida, Förenta staterna, 33065
- UM Sylvester Comprehensive Cancer Center at Coral Springs
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Deerfield Beach, Florida, Förenta staterna, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Hollywood, Florida, Förenta staterna, 33021
- UM Sylvester Comprehensive Cancer Center at Hollywood
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Jacksonville, Florida, Förenta staterna, 32207
- Baptist MD Anderson Cancer Center
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Miami, Florida, Förenta staterna, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
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Miami, Florida, Förenta staterna, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Plantation, Florida, Förenta staterna, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Weston, Florida, Förenta staterna, 33331
- Cleveland Clinic-Weston
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Georgia
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Atlanta, Georgia, Förenta staterna, 30322
- Emory University Hospital/Winship Cancer Institute
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Atlanta, Georgia, Förenta staterna, 30342
- Northside Hospital
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Idaho
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Boise, Idaho, Förenta staterna, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Förenta staterna, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Förenta staterna, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Förenta staterna, 83814
- Kootenai Health - Coeur d'Alene
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Emmett, Idaho, Förenta staterna, 83617
- Walter Knox Memorial Hospital
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Fruitland, Idaho, Förenta staterna, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Förenta staterna, 83642
- Idaho Urologic Institute-Meridian
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Meridian, Idaho, Förenta staterna, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Förenta staterna, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Förenta staterna, 83687
- Saint Luke's Cancer Institute - Nampa
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Post Falls, Idaho, Förenta staterna, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Förenta staterna, 83864
- Kootenai Clinic Cancer Services - Sandpoint
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Twin Falls, Idaho, Förenta staterna, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Förenta staterna, 61704
- Illinois CancerCare-Bloomington
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Bloomington, Illinois, Förenta staterna, 61701
- OSF Saint Joseph Medical Center
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Canton, Illinois, Förenta staterna, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, Förenta staterna, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, Förenta staterna, 62918
- SIH Cancer Institute
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Carthage, Illinois, Förenta staterna, 62321
- Illinois CancerCare-Carthage
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Centralia, Illinois, Förenta staterna, 62801
- Centralia Oncology Clinic
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
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Chicago, Illinois, Förenta staterna, 60637
- University of Chicago Comprehensive Cancer Center
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Chicago, Illinois, Förenta staterna, 60612
- University of Illinois
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Chicago, Illinois, Förenta staterna, 60608
- Mount Sinai Hospital Medical Center
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Decatur, Illinois, Förenta staterna, 62526
- Decatur Memorial Hospital
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Decatur, Illinois, Förenta staterna, 62526
- Cancer Care Specialists of Illinois - Decatur
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Dixon, Illinois, Förenta staterna, 61021
- Illinois CancerCare-Dixon
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Effingham, Illinois, Förenta staterna, 62401
- Crossroads Cancer Center
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Eureka, Illinois, Förenta staterna, 61530
- Illinois CancerCare-Eureka
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Evanston, Illinois, Förenta staterna, 60201
- NorthShore University HealthSystem-Evanston Hospital
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Galesburg, Illinois, Förenta staterna, 61401
- Western Illinois Cancer Treatment Center
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Galesburg, Illinois, Förenta staterna, 61401
- Illinois CancerCare-Galesburg
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Glenview, Illinois, Förenta staterna, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
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Highland Park, Illinois, Förenta staterna, 60035
- NorthShore University HealthSystem-Highland Park Hospital
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Highland Park, Illinois, Förenta staterna, 60035
- Hematology Oncology Associates of Illinois-Highland Park
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Kankakee, Illinois, Förenta staterna, 60901
- Presence Saint Mary's Hospital
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Kewanee, Illinois, Förenta staterna, 61443
- Illinois CancerCare-Kewanee Clinic
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Libertyville, Illinois, Förenta staterna, 60048
- AMG Libertyville - Oncology
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Macomb, Illinois, Förenta staterna, 61455
- Illinois CancerCare-Macomb
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Maywood, Illinois, Förenta staterna, 60153
- Loyola University Medical Center
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Mount Vernon, Illinois, Förenta staterna, 62864
- SSM Health Good Samaritan
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Niles, Illinois, Förenta staterna, 60714
- Illinois Cancer Specialists-Niles
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O'Fallon, Illinois, Förenta staterna, 62269
- Cancer Care Center of O'Fallon
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Ottawa, Illinois, Förenta staterna, 61350
- Illinois CancerCare-Ottawa Clinic
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Ottawa, Illinois, Förenta staterna, 61350
- Radiation Oncology of Northern Illinois
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Pekin, Illinois, Förenta staterna, 61554
- Illinois CancerCare-Pekin
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Pekin, Illinois, Förenta staterna, 61554
- OSF Saint Francis Radiation Oncology at Pekin
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Peoria, Illinois, Förenta staterna, 61636
- Methodist Medical Center of Illinois
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Peoria, Illinois, Förenta staterna, 61637
- OSF Saint Francis Medical Center
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Peoria, Illinois, Förenta staterna, 61615
- Illinois CancerCare-Peoria
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Peoria, Illinois, Förenta staterna, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
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Peru, Illinois, Förenta staterna, 61354
- Illinois CancerCare-Peru
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Peru, Illinois, Förenta staterna, 61354
- Valley Radiation Oncology
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Princeton, Illinois, Förenta staterna, 61356
- Illinois CancerCare-Princeton
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Skokie, Illinois, Förenta staterna, 60076
- Hematology Oncology Associates of Illinois - Skokie
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Skokie, Illinois, Förenta staterna, 60076
- North Shore Medical Center
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Springfield, Illinois, Förenta staterna, 62702
- Southern Illinois University School of Medicine
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Springfield, Illinois, Förenta staterna, 62702
- Springfield Clinic
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Springfield, Illinois, Förenta staterna, 62702
- Central Illinois Hematology Oncology Center
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Springfield, Illinois, Förenta staterna, 62781
- Springfield Memorial Hospital
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Swansea, Illinois, Förenta staterna, 62226
- Southwest Illinois Health Services LLP
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Indiana
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Fort Wayne, Indiana, Förenta staterna, 46805
- Parkview Hospital Randallia
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Fort Wayne, Indiana, Förenta staterna, 46845
- Parkview Regional Medical Center
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Indianapolis, Indiana, Förenta staterna, 46237
- Franciscan Health Indianapolis
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Mooresville, Indiana, Förenta staterna, 46158
- Franciscan Health Mooresville
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Richmond, Indiana, Förenta staterna, 47374
- Reid Health
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Iowa
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Ames, Iowa, Förenta staterna, 50010
- Mary Greeley Medical Center
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Ames, Iowa, Förenta staterna, 50010
- McFarland Clinic - Ames
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Boone, Iowa, Förenta staterna, 50036
- McFarland Clinic - Boone
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Fort Dodge, Iowa, Förenta staterna, 50501
- McFarland Clinic - Trinity Cancer Center
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Jefferson, Iowa, Förenta staterna, 50129
- McFarland Clinic - Jefferson
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Marshalltown, Iowa, Förenta staterna, 50158
- McFarland Clinic - Marshalltown
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Kansas
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Chanute, Kansas, Förenta staterna, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Förenta staterna, 67801
- Cancer Center of Kansas - Dodge City
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El Dorado, Kansas, Förenta staterna, 67042
- Cancer Center of Kansas - El Dorado
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Fort Scott, Kansas, Förenta staterna, 66701
- Cancer Center of Kansas - Fort Scott
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Garden City, Kansas, Förenta staterna, 67846
- Central Care Cancer Center - Garden City
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Great Bend, Kansas, Förenta staterna, 67530
- Central Care Cancer Center - Great Bend
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Independence, Kansas, Förenta staterna, 67301
- Cancer Center of Kansas-Independence
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Kansas City, Kansas, Förenta staterna, 66160
- University of Kansas Cancer Center
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Kingman, Kansas, Förenta staterna, 67068
- Cancer Center of Kansas-Kingman
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Lawrence, Kansas, Förenta staterna, 66044
- Lawrence Memorial Hospital
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Lenexa, Kansas, Förenta staterna, 66219
- Kansas Institute of Medicine Cancer and Blood Center
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Lenexa, Kansas, Förenta staterna, 66219
- Minimally Invasive Surgery Hospital
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Liberal, Kansas, Förenta staterna, 67905
- Cancer Center of Kansas-Liberal
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Manhattan, Kansas, Förenta staterna, 66502
- Cancer Center of Kansas-Manhattan
-
McPherson, Kansas, Förenta staterna, 67460
- Cancer Center of Kansas - McPherson
-
Newton, Kansas, Förenta staterna, 67114
- Cancer Center of Kansas - Newton
-
Olathe, Kansas, Förenta staterna, 66061
- The University of Kansas Cancer Center - Olathe
-
Overland Park, Kansas, Förenta staterna, 66209
- Menorah Medical Center
-
Overland Park, Kansas, Förenta staterna, 66213
- Saint Luke's South Hospital
-
Parsons, Kansas, Förenta staterna, 67357
- Cancer Center of Kansas - Parsons
-
Pratt, Kansas, Förenta staterna, 67124
- Cancer Center of Kansas - Pratt
-
Salina, Kansas, Förenta staterna, 67401
- Cancer Center of Kansas - Salina
-
Wellington, Kansas, Förenta staterna, 67152
- Cancer Center of Kansas - Wellington
-
Westwood, Kansas, Förenta staterna, 66205
- University of Kansas Hospital-Westwood Cancer Center
-
Wichita, Kansas, Förenta staterna, 67214
- Ascension Via Christi Hospitals Wichita
-
Wichita, Kansas, Förenta staterna, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita, Kansas, Förenta staterna, 67214
- Cancer Center of Kansas - Wichita
-
Wichita, Kansas, Förenta staterna, 67208
- Associates In Womens Health
-
Wichita, Kansas, Förenta staterna, 67214
- Wesley Medical Center
-
Winfield, Kansas, Förenta staterna, 67156
- Cancer Center of Kansas - Winfield
-
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Kentucky
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Crestview Hills, Kentucky, Förenta staterna, 41017
- Oncology Hematology Care Inc-Crestview
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Louisville, Kentucky, Förenta staterna, 40202
- The James Graham Brown Cancer Center at University of Louisville
-
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Louisiana
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Baton Rouge, Louisiana, Förenta staterna, 70809
- Ochsner Health Center-Summa
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Baton Rouge, Louisiana, Förenta staterna, 70816
- Medical Center of Baton Rouge
-
Baton Rouge, Louisiana, Förenta staterna, 70836
- Ochsner High Grove
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Monroe, Louisiana, Förenta staterna, 71202
- Ochsner LSU Health Monroe Medical Center
-
New Orleans, Louisiana, Förenta staterna, 70121
- Ochsner Medical Center Jefferson
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Shreveport, Louisiana, Förenta staterna, 71103
- LSU Health Sciences Center at Shreveport
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Maine
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Bangor, Maine, Förenta staterna, 04401
- Eastern Maine Medical Center
-
Brewer, Maine, Förenta staterna, 04412
- Lafayette Family Cancer Center-EMMC
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Maryland
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Baltimore, Maryland, Förenta staterna, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Baltimore, Maryland, Förenta staterna, 21201
- University of Maryland/Greenebaum Cancer Center
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Bethesda, Maryland, Förenta staterna, 20889-5600
- Walter Reed National Military Medical Center
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Massachusetts
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Boston, Massachusetts, Förenta staterna, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, Förenta staterna, 02215
- Dana-Farber Cancer Institute
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Boston, Massachusetts, Förenta staterna, 02114
- Massachusetts General Hospital Cancer Center
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Michigan
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Adrian, Michigan, Förenta staterna, 49221
- Bixby Medical Center
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Adrian, Michigan, Förenta staterna, 49221
- Hickman Cancer Center
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Ann Arbor, Michigan, Förenta staterna, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
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Battle Creek, Michigan, Förenta staterna, 49017
- Bronson Battle Creek
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Brownstown, Michigan, Förenta staterna, 48183
- Henry Ford Cancer Institute-Downriver
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Clinton Township, Michigan, Förenta staterna, 48038
- Henry Ford Macomb Hospital-Clinton Township
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Dearborn, Michigan, Förenta staterna, 48126
- Henry Ford Medical Center-Fairlane
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Dearborn, Michigan, Förenta staterna, 48124
- Corewell Health Dearborn Hospital
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Detroit, Michigan, Förenta staterna, 48202
- Henry Ford Hospital
-
Detroit, Michigan, Förenta staterna, 48201
- Wayne State University/Karmanos Cancer Institute
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Detroit, Michigan, Förenta staterna, 48236
- Henry Ford Health Saint John Hospital
-
Escanaba, Michigan, Förenta staterna, 49829
- OSF Saint Francis Hospital and Medical Group
-
Farmington Hills, Michigan, Förenta staterna, 48334
- Weisberg Cancer Treatment Center
-
Farmington Hills, Michigan, Förenta staterna, 48336
- Corewell Health Farmington Hills Hospital
-
Flint, Michigan, Förenta staterna, 48503
- Hurley Medical Center
-
Flint, Michigan, Förenta staterna, 48503
- Genesys Hurley Cancer Institute
-
Grand Rapids, Michigan, Förenta staterna, 49503
- Trinity Health Grand Rapids Hospital
-
Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Grand Rapids, Michigan, Förenta staterna, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
-
Grosse Pointe, Michigan, Förenta staterna, 48230
- William Beaumont Hospital-Grosse Pointe
-
Jackson, Michigan, Förenta staterna, 49201
- Allegiance Health
-
Kalamazoo, Michigan, Förenta staterna, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Förenta staterna, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Förenta staterna, 49048
- Beacon Kalamazoo
-
Lansing, Michigan, Förenta staterna, 48912
- University of Michigan Health - Sparrow Lansing
-
Livonia, Michigan, Förenta staterna, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Monroe, Michigan, Förenta staterna, 48162
- Mercy Memorial Hospital
-
Monroe, Michigan, Förenta staterna, 48162
- Toledo Clinic Cancer Centers-Monroe
-
Muskegon, Michigan, Förenta staterna, 49444
- Trinity Health Muskegon Hospital
-
Niles, Michigan, Förenta staterna, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Norton Shores, Michigan, Förenta staterna, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Novi, Michigan, Förenta staterna, 48377
- Henry Ford Medical Center-Columbus
-
Pontiac, Michigan, Förenta staterna, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Port Huron, Michigan, Förenta staterna, 48060
- Lake Huron Medical Center
-
Port Huron, Michigan, Förenta staterna, 48060
- Huron Medical Center PC
-
Reed City, Michigan, Förenta staterna, 49677
- Corewell Health Reed City Hospital
-
Roseville, Michigan, Förenta staterna, 48066
- Michigan Cancer Specialists
-
Royal Oak, Michigan, Förenta staterna, 48073
- Cancer Care Associates PC
-
Royal Oak, Michigan, Förenta staterna, 48073
- Comprehensive Medical Center PLLC
-
Royal Oak, Michigan, Förenta staterna, 48073
- Oakland Medical Group
-
Royal Oak, Michigan, Förenta staterna, 48067
- Oakland Colon Rectal Associates
-
Royal Oak, Michigan, Förenta staterna, 48073
- Hematology Oncology Consultants PC-Royal Oak
-
Royal Oak, Michigan, Förenta staterna, 48073
- Corewell Health William Beaumont University Hospital
-
Saginaw, Michigan, Förenta staterna, 48601
- MyMichigan Medical Center Saginaw
-
Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Förenta staterna, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Sterling Heights, Michigan, Förenta staterna, 48312
- Premier Hematology Oncology Care
-
Sterling Heights, Michigan, Förenta staterna, 48314
- Mitchell Folbe MD PC
-
Traverse City, Michigan, Förenta staterna, 49684
- Munson Medical Center
-
Troy, Michigan, Förenta staterna, 48084
- Michigan Institute of Urology-Town Center
-
Troy, Michigan, Förenta staterna, 48085
- Claudia BR Herke MD PC
-
Troy, Michigan, Förenta staterna, 48098
- Hematology Oncology Consultants PC-Troy
-
Troy, Michigan, Förenta staterna, 48085
- Corewell Health Beaumont Troy Hospital
-
Warren, Michigan, Förenta staterna, 48093
- Henry Ford Health Warren Hospital
-
West Bloomfield, Michigan, Förenta staterna, 48322
- Henry Ford West Bloomfield Hospital
-
Wyoming, Michigan, Förenta staterna, 49519
- University of Michigan Health - West
-
-
Minnesota
-
Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic in Rochester
-
-
Missouri
-
Ballwin, Missouri, Förenta staterna, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bolivar, Missouri, Förenta staterna, 65613
- Central Care Cancer Center - Bolivar
-
Bonne Terre, Missouri, Förenta staterna, 63628
- Parkland Health Center-Bonne Terre
-
Branson, Missouri, Förenta staterna, 65616
- Cox Cancer Center Branson
-
Cape Girardeau, Missouri, Förenta staterna, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, Förenta staterna, 63703
- Mercy Cancer Center - Cape Girardeau
-
City of Saint Peters, Missouri, Förenta staterna, 63376
- Siteman Cancer Center at Saint Peters Hospital
-
Creve Coeur, Missouri, Förenta staterna, 63141
- Siteman Cancer Center at West County Hospital
-
Farmington, Missouri, Förenta staterna, 63640
- Parkland Health Center - Farmington
-
Independence, Missouri, Förenta staterna, 64057
- Centerpoint Medical Center LLC
-
Jefferson City, Missouri, Förenta staterna, 65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin, Missouri, Förenta staterna, 64804
- Freeman Health System
-
Joplin, Missouri, Förenta staterna, 64804
- Mercy Hospital Joplin
-
Kansas City, Missouri, Förenta staterna, 64111
- Saint Luke's Hospital of Kansas City
-
Kansas City, Missouri, Förenta staterna, 64132
- Research Medical Center
-
Kansas City, Missouri, Förenta staterna, 64118
- Heartland Hematology and Oncology Associates Incorporated
-
Lee's Summit, Missouri, Förenta staterna, 64086
- Saint Luke's East - Lee's Summit
-
Liberty, Missouri, Förenta staterna, 64068
- Liberty Hospital
-
Rolla, Missouri, Förenta staterna, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, Förenta staterna, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, Förenta staterna, 64506
- Heartland Regional Medical Center
-
Sainte Genevieve, Missouri, Förenta staterna, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, Förenta staterna, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Förenta staterna, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Förenta staterna, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Förenta staterna, 63129
- Siteman Cancer Center-South County
-
St Louis, Missouri, Förenta staterna, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Förenta staterna, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, Förenta staterna, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Förenta staterna, 63128
- Mercy Hospital South
-
Sullivan, Missouri, Förenta staterna, 63080
- Missouri Baptist Sullivan Hospital
-
Washington, Missouri, Förenta staterna, 63090
- Mercy Hospital Washington
-
-
Montana
-
Anaconda, Montana, Förenta staterna, 59711
- Community Hospital of Anaconda
-
Billings, Montana, Förenta staterna, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, Förenta staterna, 59101
- Saint Vincent Healthcare
-
Billings, Montana, Förenta staterna, 59102
- Saint Vincent Frontier Cancer Center
-
Bozeman, Montana, Förenta staterna, 59715
- Bozeman Health Deaconess Hospital
-
Butte, Montana, Förenta staterna, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, Förenta staterna, 59405
- Great Falls Clinic
-
Great Falls, Montana, Förenta staterna, 59405
- Benefis Sletten Cancer Institute
-
Helena, Montana, Förenta staterna, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, Förenta staterna, 59901
- Logan Health Medical Center
-
Missoula, Montana, Förenta staterna, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, Förenta staterna, 59804
- Community Medical Center
-
-
Nebraska
-
Bellevue, Nebraska, Förenta staterna, 68123
- Nebraska Medicine-Bellevue
-
Omaha, Nebraska, Förenta staterna, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, Förenta staterna, 68118
- Nebraska Medicine-Village Pointe
-
-
Nevada
-
Carson City, Nevada, Förenta staterna, 89703
- Carson Tahoe Regional Medical Center
-
Henderson, Nevada, Förenta staterna, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Förenta staterna, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, Förenta staterna, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Förenta staterna, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Förenta staterna, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, Förenta staterna, 89074
- Las Vegas Urology - Green Valley
-
Henderson, Nevada, Förenta staterna, 89074
- Las Vegas Urology - Pebble
-
Henderson, Nevada, Förenta staterna, 89074
- Urology Specialists of Nevada - Green Valley
-
Henderson, Nevada, Förenta staterna, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Förenta staterna, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, Förenta staterna, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, Förenta staterna, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Förenta staterna, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Förenta staterna, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Förenta staterna, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Förenta staterna, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, Förenta staterna, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Förenta staterna, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, Förenta staterna, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Förenta staterna, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Förenta staterna, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Förenta staterna, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Förenta staterna, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, Förenta staterna, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Förenta staterna, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Förenta staterna, 89121
- Cancer Therapy and Integrative Medicine
-
Las Vegas, Nevada, Förenta staterna, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, Förenta staterna, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Förenta staterna, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Förenta staterna, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Förenta staterna, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, Förenta staterna, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, Förenta staterna, 89102
- Desert West Surgery
-
Las Vegas, Nevada, Förenta staterna, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, Förenta staterna, 89106
- Urology Specialists of Nevada - Central
-
Las Vegas, Nevada, Förenta staterna, 89113
- Las Vegas Prostate Cancer Center
-
Las Vegas, Nevada, Förenta staterna, 89113
- Las Vegas Urology - Sunset
-
Las Vegas, Nevada, Förenta staterna, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, Förenta staterna, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, Förenta staterna, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, Förenta staterna, 89169
- University Cancer Center
-
Las Vegas, Nevada, Förenta staterna, 89113
- Urology Specialists of Nevada - Southwest
-
Las Vegas, Nevada, Förenta staterna, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, Förenta staterna, 89183
- OptumCare Cancer Care at Fort Apache
-
Pahrump, Nevada, Förenta staterna, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, Förenta staterna, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Förenta staterna, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Förenta staterna, 89509
- Radiation Oncology Associates
-
-
New Hampshire
-
Lebanon, New Hampshire, Förenta staterna, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Basking Ridge, New Jersey, Förenta staterna, 07920
- Memorial Sloan Kettering Basking Ridge
-
Middletown, New Jersey, Förenta staterna, 07748
- Memorial Sloan Kettering Monmouth
-
Montvale, New Jersey, Förenta staterna, 07645
- Memorial Sloan Kettering Bergen
-
New Brunswick, New Jersey, Förenta staterna, 08903
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
Buffalo, New York, Förenta staterna, 14263
- Roswell Park Cancer Institute
-
Commack, New York, Förenta staterna, 11725
- Memorial Sloan Kettering Commack
-
Harrison, New York, Förenta staterna, 10604
- Memorial Sloan Kettering Westchester
-
Lake Success, New York, Förenta staterna, 11042
- Northwell Health/Center for Advanced Medicine
-
Manhasset, New York, Förenta staterna, 11030
- North Shore University Hospital
-
New Hyde Park, New York, Förenta staterna, 11040
- Long Island Jewish Medical Center
-
New York, New York, Förenta staterna, 10065
- Memorial Sloan Kettering Cancer Center
-
Rochester, New York, Förenta staterna, 14642
- University of Rochester
-
Stony Brook, New York, Förenta staterna, 11794
- Stony Brook University Medical Center
-
The Bronx, New York, Förenta staterna, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, Förenta staterna, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, Förenta staterna, 10461
- Montefiore Medical Center-Weiler Hospital
-
Uniondale, New York, Förenta staterna, 11553
- Memorial Sloan Kettering Nassau
-
-
North Carolina
-
Asheville, North Carolina, Förenta staterna, 28803
- AdventHealth Infusion Center Asheville
-
Chapel Hill, North Carolina, Förenta staterna, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Clyde, North Carolina, Förenta staterna, 28721
- AdventHealth Infusion Center Haywood
-
Hendersonville, North Carolina, Förenta staterna, 28792
- AdventHealth Hendersonville
-
Winston-Salem, North Carolina, Förenta staterna, 27157
- Wake Forest University Health Sciences
-
-
Ohio
-
Beavercreek, Ohio, Förenta staterna, 45431
- Indu and Raj Soin Medical Center
-
Boardman, Ohio, Förenta staterna, 44512
- Saint Elizabeth Boardman Hospital
-
Bowling Green, Ohio, Förenta staterna, 43402
- Toledo Clinic Cancer Centers-Bowling Green
-
Centerville, Ohio, Förenta staterna, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, Förenta staterna, 45459
- Dayton Physicians LLC-Miami Valley South
-
Cincinnati, Ohio, Förenta staterna, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, Förenta staterna, 45242
- Oncology Hematology Care Inc-Blue Ash
-
Cincinnati, Ohio, Förenta staterna, 45202
- Oncology Hematology Care Inc-Eden Park
-
Cincinnati, Ohio, Förenta staterna, 45211
- Oncology Hematology Care Inc-Mercy West
-
Cincinnati, Ohio, Förenta staterna, 45230
- Oncology Hematology Care Inc-Anderson
-
Cincinnati, Ohio, Förenta staterna, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cleveland, Ohio, Förenta staterna, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Foundation
-
Columbus, Ohio, Förenta staterna, 43210
- Ohio State University Comprehensive Cancer Center
-
Dayton, Ohio, Förenta staterna, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, Förenta staterna, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Förenta staterna, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, Förenta staterna, 45415
- Dayton Physician LLC - Englewood
-
Fairfield, Ohio, Förenta staterna, 45014
- Oncology Hematology Care Inc-Healthplex
-
Findlay, Ohio, Förenta staterna, 45840
- Blanchard Valley Hospital
-
Findlay, Ohio, Förenta staterna, 45840
- Armes Family Cancer Center
-
Findlay, Ohio, Förenta staterna, 45840
- Orion Cancer Care
-
Franklin, Ohio, Förenta staterna, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin, Ohio, Förenta staterna, 45005
- Dayton Physicians LLC-Atrium
-
Greenville, Ohio, Förenta staterna, 45331
- Wayne Hospital
-
Greenville, Ohio, Förenta staterna, 45331
- Dayton Physicians LLC-Wayne
-
Kettering, Ohio, Förenta staterna, 45429
- Kettering Medical Center
-
Kettering, Ohio, Förenta staterna, 45409
- Greater Dayton Cancer Center
-
Kettering, Ohio, Förenta staterna, 45420
- First Dayton Cancer Care
-
Lima, Ohio, Förenta staterna, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, Förenta staterna, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Maumee, Ohio, Förenta staterna, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
-
Middletown, Ohio, Förenta staterna, 45042
- Dayton Physicians LLC-Signal Point
-
Oregon, Ohio, Förenta staterna, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Förenta staterna, 43616
- Toledo Clinic Cancer Centers-Oregon
-
Sidney, Ohio, Förenta staterna, 45365
- Dayton Physicians LLC-Wilson
-
Springfield, Ohio, Förenta staterna, 45504
- Springfield Regional Cancer Center
-
Springfield, Ohio, Förenta staterna, 45504
- Springfield Regional Medical Center
-
Sylvania, Ohio, Förenta staterna, 43560
- ProMedica Flower Hospital
-
Tiffin, Ohio, Förenta staterna, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Förenta staterna, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Toledo, Ohio, Förenta staterna, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, Förenta staterna, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo, Ohio, Förenta staterna, 43614
- University of Toledo
-
Toledo, Ohio, Förenta staterna, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, Förenta staterna, 43608
- Mercy Health - Saint Vincent Hospital
-
Troy, Ohio, Förenta staterna, 45373
- Upper Valley Medical Center
-
Troy, Ohio, Förenta staterna, 45373
- Dayton Physicians LLC - Troy
-
Warren, Ohio, Förenta staterna, 44484
- Saint Joseph Warren Hospital
-
Wauseon, Ohio, Förenta staterna, 43567
- Fulton County Health Center
-
West Chester, Ohio, Förenta staterna, 45069
- University of Cincinnati Cancer Center-West Chester
-
Wright-Patterson Air Force Base, Ohio, Förenta staterna, 45433
- Wright-Patterson Medical Center
-
Youngstown, Ohio, Förenta staterna, 44501
- Saint Elizabeth Youngstown Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Förenta staterna, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Förenta staterna, 73120
- Mercy Hospital Oklahoma City
-
-
Oregon
-
Baker City, Oregon, Förenta staterna, 97814
- Saint Alphonsus Cancer Care Center-Baker City
-
Bend, Oregon, Förenta staterna, 97701
- Saint Charles Health System
-
Clackamas, Oregon, Förenta staterna, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, Förenta staterna, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, Förenta staterna, 97420
- Bay Area Hospital
-
Newberg, Oregon, Förenta staterna, 97132
- Providence Newberg Medical Center
-
Ontario, Oregon, Förenta staterna, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Oregon City, Oregon, Förenta staterna, 97045
- Providence Willamette Falls Medical Center
-
Portland, Oregon, Förenta staterna, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Förenta staterna, 97225
- Providence Saint Vincent Medical Center
-
Redmond, Oregon, Förenta staterna, 97756
- Saint Charles Health System-Redmond
-
-
Pennsylvania
-
Danville, Pennsylvania, Förenta staterna, 17822
- Geisinger Medical Center
-
Hershey, Pennsylvania, Förenta staterna, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Philadelphia, Pennsylvania, Förenta staterna, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Förenta staterna, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Förenta staterna, 19104
- University of Pennsylvania/Abramson Cancer Center
-
Pittsburgh, Pennsylvania, Förenta staterna, 15232
- UPMC Hillman Cancer Center
-
Scranton, Pennsylvania, Förenta staterna, 18510
- Community Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Förenta staterna, 29621
- AnMed Health Cancer Center
-
Boiling Springs, South Carolina, Förenta staterna, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Easley, South Carolina, Förenta staterna, 29640
- Prisma Health Cancer Institute - Easley
-
Gaffney, South Carolina, Förenta staterna, 29341
- Gibbs Cancer Center-Gaffney
-
Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Förenta staterna, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, Förenta staterna, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, Förenta staterna, 29601
- Saint Francis Hospital
-
Greenville, South Carolina, Förenta staterna, 29605
- Prisma Health Greenville Memorial Hospital
-
Greenville, South Carolina, Förenta staterna, 29601
- Greenville Health System Cancer Institute-Andrews
-
Greer, South Carolina, Förenta staterna, 29650
- Prisma Health Cancer Institute - Greer
-
Greer, South Carolina, Förenta staterna, 29651
- Gibbs Cancer Center-Pelham
-
Lancaster, South Carolina, Förenta staterna, 29720
- Carolina Blood and Cancer Care Associates PA-Lancaster
-
Rock Hill, South Carolina, Förenta staterna, 29732
- Carolina Blood and Cancer Care Associates PA
-
Seneca, South Carolina, Förenta staterna, 29672
- Prisma Health Cancer Institute - Seneca
-
Spartanburg, South Carolina, Förenta staterna, 29303
- Spartanburg Medical Center
-
-
Tennessee
-
Franklin, Tennessee, Förenta staterna, 37067
- Vanderbilt-Ingram Cancer Center Cool Springs
-
Nashville, Tennessee, Förenta staterna, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Förenta staterna, 37204
- Vanderbilt Breast Center at One Hundred Oaks
-
-
Texas
-
Dallas, Texas, Förenta staterna, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, Förenta staterna, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Houston, Texas, Förenta staterna, 77030
- Houston Methodist Hospital
-
Houston, Texas, Förenta staterna, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Houston, Texas, Förenta staterna, 77030
- Ben Taub General Hospital
-
-
Utah
-
American Fork, Utah, Förenta staterna, 84003
- American Fork Hospital / Huntsman Intermountain Cancer Center
-
Cedar City, Utah, Förenta staterna, 84720
- Sandra L Maxwell Cancer Center
-
Farmington, Utah, Förenta staterna, 84025
- Farmington Health Center
-
Logan, Utah, Förenta staterna, 84321
- Logan Regional Hospital
-
Murray, Utah, Förenta staterna, 84107
- Intermountain Medical Center
-
Ogden, Utah, Förenta staterna, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, Förenta staterna, 84604
- Utah Valley Regional Medical Center
-
Riverton, Utah, Förenta staterna, 84065
- Riverton Hospital
-
Salt Lake City, Utah, Förenta staterna, 84112
- Huntsman Cancer Institute/University of Utah
-
Salt Lake City, Utah, Förenta staterna, 84106
- Utah Cancer Specialists-Salt Lake City
-
Salt Lake City, Utah, Förenta staterna, 84143
- LDS Hospital
-
South Jordan, Utah, Förenta staterna, 84009
- South Jordan Health Center
-
St. George, Utah, Förenta staterna, 84770
- Saint George Regional Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, Förenta staterna, 22401
- Fredericksburg Oncology Inc
-
Richmond, Virginia, Förenta staterna, 23235
- VCU Massey Cancer Center at Stony Point
-
Richmond, Virginia, Förenta staterna, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Aberdeen, Washington, Förenta staterna, 98520
- Providence Regional Cancer System-Aberdeen
-
Anacortes, Washington, Förenta staterna, 98221
- Cancer Care Center at Island Hospital
-
Auburn, Washington, Förenta staterna, 98001
- MultiCare Auburn Medical Center
-
Bellevue, Washington, Förenta staterna, 98004
- Overlake Medical Center
-
Bellevue, Washington, Förenta staterna, 98005
- Swedish Cancer Institute-Eastside Oncology Hematology
-
Bellingham, Washington, Förenta staterna, 98225
- PeaceHealth Saint Joseph Medical Center
-
Centralia, Washington, Förenta staterna, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, Förenta staterna, 98026
- Swedish Cancer Institute-Edmonds
-
Everett, Washington, Förenta staterna, 98201
- Providence Regional Cancer Partnership
-
Gig Harbor, Washington, Förenta staterna, 98335
- MultiCare Gig Harbor Medical Park
-
Issaquah, Washington, Förenta staterna, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, Förenta staterna, 99336
- Kadlec Clinic Hematology and Oncology
-
Lacey, Washington, Förenta staterna, 98503
- Providence Regional Cancer System-Lacey
-
Longview, Washington, Förenta staterna, 98632
- PeaceHealth Saint John Medical Center
-
Port Townsend, Washington, Förenta staterna, 98368
- Jefferson Healthcare
-
Puyallup, Washington, Förenta staterna, 98372
- MultiCare Good Samaritan Hospital
-
Renton, Washington, Förenta staterna, 98055
- Valley Medical Center
-
Seattle, Washington, Förenta staterna, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, Förenta staterna, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, Förenta staterna, 98112
- Kaiser Permanente Washington
-
Seattle, Washington, Förenta staterna, 98104
- Minor and James Medical PLLC
-
Seattle, Washington, Förenta staterna, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, Förenta staterna, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Sedro-Woolley, Washington, Förenta staterna, 98284
- PeaceHealth United General Medical Center
-
Shelton, Washington, Förenta staterna, 98584
- Providence Regional Cancer System-Shelton
-
Spokane, Washington, Förenta staterna, 99218
- Evergreen Hematology and Oncology PS
-
Spokane, Washington, Förenta staterna, 99204
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
-
Spokane, Washington, Förenta staterna, 99218
- MultiCare Deaconess Cancer and Blood Specialty Center - North
-
Spokane Valley, Washington, Förenta staterna, 99216
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
-
Tacoma, Washington, Förenta staterna, 98405
- Mary Bridge Children's Hospital and Health Center
-
Tacoma, Washington, Förenta staterna, 98405
- MultiCare Tacoma General Hospital
-
Vancouver, Washington, Förenta staterna, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, Förenta staterna, 99362
- Providence Saint Mary Regional Cancer Center
-
Yakima, Washington, Förenta staterna, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
Yelm, Washington, Förenta staterna, 98597
- Providence Regional Cancer System-Yelm
-
-
Wisconsin
-
Eau Claire, Wisconsin, Förenta staterna, 54701
- Marshfield Medical Center-EC Cancer Center
-
Eau Claire, Wisconsin, Förenta staterna, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, Förenta staterna, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Förenta staterna, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
La Crosse, Wisconsin, Förenta staterna, 54601
- Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Förenta staterna, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Manitowoc, Wisconsin, Förenta staterna, 54221
- Holy Family Memorial Hospital
-
Marinette, Wisconsin, Förenta staterna, 54143
- Saint Vincent Hospital Cancer Center at Marinette
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Medical Center-Marshfield
-
Marshfield, Wisconsin, Förenta staterna, 54449
- Marshfield Medical Center
-
Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, Förenta staterna, 54548
- Marshfield Medical Center - Minocqua
-
Oconto Falls, Wisconsin, Förenta staterna, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Rice Lake, Wisconsin, Förenta staterna, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Förenta staterna, 53081
- HSHS Saint Nicholas Hospital
-
Stevens Point, Wisconsin, Förenta staterna, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Sturgeon Bay, Wisconsin, Förenta staterna, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Wausau, Wisconsin, Förenta staterna, 54401
- Marshfield Clinic-Wausau Center
-
Weston, Wisconsin, Förenta staterna, 54476
- Marshfield Medical Center - Weston
-
-
Wyoming
-
Casper, Wyoming, Förenta staterna, 82609
- Rocky Mountain Oncology
-
Cheyenne, Wyoming, Förenta staterna, 82001
- Cheyenne Regional Medical Center-West
-
Cody, Wyoming, Förenta staterna, 82414
- Big Horn Basin Cancer Center
-
Cody, Wyoming, Förenta staterna, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, Förenta staterna, 82801
- Welch Cancer Center
-
-
-
-
-
Haifa, Israel, 31096
- Rambam Medical Center
-
Jerusalem, Israel, 91031
- Shaare Zedek Medical Center
-
-
-
-
Alberta
-
Calgary, Alberta, Kanada, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
-
-
British Columbia
-
Vancouver, British Columbia, Kanada, V5Z 3P1
- Clinical Research Unit at Vancouver Coastal Health Authority
-
-
Nova Scotia
-
Halifax, Nova Scotia, Kanada, B3H 2Y9
- QEII Health Sciences Centre/Nova Scotia Health Authority
-
-
Ontario
-
Kingston, Ontario, Kanada, K7L 2V7
- Kingston Health Sciences Centre
-
-
Quebec
-
Montreal, Quebec, Kanada, H1T 2M4
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
-
-
Saskatchewan
-
Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre
-
-
-
-
-
Bayamón, Puerto Rico, 00959-5060
- Cancer Center-Metro Medical Center Bayamon
-
Manati, Puerto Rico, 00674
- Doctors Cancer Center
-
San Juan, Puerto Rico, 00917
- San Juan Community Oncology Group
-
San Juan, Puerto Rico, 00927
- Centro Comprensivo de Cancer de UPR
-
San Juan, Puerto Rico, 00936
- San Juan City Hospital
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
-
PRE-REGISTRATION
-
Diagnostic bone marrow and/or peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing, and the establishment of BCR/ABL status; testing will be performed by the Eastern Cooperative Oncology Group (ECOG)-American College of Radiation Imaging Network (ACRIN) Leukemia Translational Research Laboratory (LTRL) and reported to the institution
- NOTE: IT IS ESSENTIAL THAT A SAMPLE CONTAINING SUFFICIENT BLAST CELLS BE SUBMITTED TO THE ECOG-ACRIN LTRL AT BASELINE SO THAT SUBSEQUENT BONE MARROW ASSESSMENTS OF MRD CAN BE DONE; IN ADDITION TO ALLOWING THE LTRL TO CONFIRM ELIGIBILITY BASED ON BLAST CELL IMMUNOPHENOTYPE AND BCR/ABL STATUS, IT IS ALSO IMPERATIVE THAT AN ADEQUATE NUMBER OF BLASTS BE BANKED FOR ANALYSIS BY DRS MULLIGHAN/WILLMAN. WITHOUT ADEQUATE BASELINE SAMPLES, PATIENTS WILL NOT BE ABLE TO BE TREATED AND RANDOMIZED ON THIS PROTOCOL; IF A BONE MARROW ASPIRATE IS NOT AVAILABLE FOR LTRL SUBMISSION AT BASELINE, IT IS IMPERATIVE THAT DR PAIETTA FROM THE LTRL IS CALLED TO DISCUSS THE PERIPHERAL BLOOD WHITE BLOOD CELL (WBC) AND BLAST COUNT BEFORE BLOOD ONLY IS SUBMITTED
- NOTE: Hydroxyurea can be given for up to 5 days prior to initiation of protocol therapy for control of leukocyte count and/or other symptoms or signs; corticosteroids can be given after pre-registration to the protocol and submission of baseline marrow and blood samples for control of leukocyte count and/or other symptoms or signs prior to initiation of protocol therapy if needed; if corticosteroids are given prior to pre-registration, contact the study chair as the patient may still be eligible to participate
-
INDUCTION ELIGIBILITY CRITERIA-STEP 1
-
Age >= 30 years and =< 70 years
-
New diagnosis of B lineage ALL must be made upon bone marrow or peripheral blood immunophenotyping; cases with myeloid antigen expression, but unequivocal lymphoid immunophenotype, are eligible
-
Negativity for the Philadelphia chromosome must be established by conventional cytogenetics, fluorescence in situ hybridization (FISH) and/or polymerase chain reaction (PCR); patients who are negative for the Philadelphia chromosome by conventional cytogenetics must have FISH or PCR performed for BCR/ABL to exclude occult translocations
-
Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts from peripheral blood; FISH testing for common B-lineage ALL abnormalities including t(9;22) (BCR/ABL1), t(12;21) (ETS-variant gene 6 [ETV6]/runt-related transcription factor 1 [RUNX1]), t(1;19) (pre-B-cell leukemia homeobox 1 [PBX1]/transcription factor 3 [TCF3]), +4,+10,+17, (centromeric [Cen]4/Cen10/Cen17), t(11q23;var), (myeloid/lymphoid or mixed lineage leukemia [MLL]), deletion (del)(9p) (cyclin-dependent kinase inhibitor 2A [CDKN2A]/Cen9), and t(14;var) (immunoglobulin heavy chain [IGH] is encouraged); if there are few or no circulating blasts and an adequate marrow sample cannot be obtained for cytogenetic analysis, the patient may still enroll on the trial
-
Serum direct bilirubin < 2 mg/dl or serum total bilirubin =< 3 (obtained =< 48 hours prior to registration); NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration
-
Serum creatinine < 2 mg/dl (obtained =< 48 hours prior to registration); NOTE: the above stipulation for normal hepatic function does not apply if liver dysfunction is due to leukemia infiltration
-
Patient should be human leukocyte antigen (HLA) typed (A, B, C, DR and DQ) during induction therapy phase or a written explanation for not undergoing HLA typing on the flow sheet
-
Patients with known human immunodeficiency virus (HIV) infection are eligible if they meet all of the following criteria:
- No history of acquired immune deficiency syndrome (AIDS)-related complications other than a history of low CD4+ T-cell count (< 200/mm^3) prior to initiation of combination antiretroviral therapy; on study CD4+ T-cell count may not be informative due to leukemia and should not be used as an exclusion criterion if low
- Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the leukemia
- Patient must have serum HIV viral load of < 200 copies/mm^3
- Patient must be on combination antiretroviral therapy with minimal pharmacokinetic interactions with study therapy and minimal overlapping clinical toxicity with protocol therapy
- Patient must not be receiving protease inhibitors or once daily formulations containing cobicistat, stavudine, or on regimens containing stavudine or zidovudine
- It is recommended to utilize a regimen of the integrase inhibitor, dolutegravir, combined with either disoproxil fumarate/emtricitabine or dolutegravir combined with tenofovir alafenamide/emtricitabine
-
Patient must have no history of recent myocardial infarction (within three months), uncontrolled congestive heart failure, or uncontrolled cardiac arrhythmia
-
Patient must have a normal cardiac ejection fraction by pretreatment multigated acquisition scan (MUGA) or echocardiogram within 4 weeks prior to registration (resting ejection fraction >= 40% or >= 5% increase with exercise), shortening fraction by echocardiogram >= 24%, or to within the normal range of values for the institution
-
Women must not be pregnant or breast-feeding due to administration of teratogenic chemotherapy and must not become pregnant or breastfeed during protocol therapy and for at least 3 months after protocol therapy; woman of childbearing potential must abstain from sexual activity or be willing to use 2 highly effective forms of contraception throughout protocol therapy and for at least an additional 3 months after the last dose of protocol-specified therapy; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of whether they have undergone tubal ligation, who meets the following criteria: has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
-
Men who have a female partner of childbearing potential must be willing to use 2 highly effective forms of contraception throughout protocol therapy and for at least an additional 3 months after the last dose of protocol-specified therapy; men who have a pregnant partner must be willing to use a condom during sexual activity throughout protocol therapy and for 3 months after the last dose of protocol-specified therapy
-
ECOG performance score 0-3
-
Patient must have given written informed consent
-
POST-INDUCTION THERAPY ELIGIBILITY CRITERIA (PRIOR TO INTENSIFICATION-STEP 2)
-
ECOG performance status 0-2
-
Patients must have achieved a CR or CRi
-
Patients who have achieved a CR or CRi must have maintained peripheral blood evidence of a CR or CRi
-
Patient must be CNS (cerebrospinal fluid [CSF]) negative for leukemia
-
Patients must have resolved any serious infectious complications related to induction
-
Any significant medical complications related to induction must have resolved
-
Serum creatinine =< 2.0 mg/dl (obtained =< 48 hours prior to registration)
-
Serum direct bilirubin < 2 mg/dL or serum total bilirubin =< 3 (obtained =< 48 hours prior to registration)
-
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 x upper limit of normal (ULN) (obtained =< 48 hours prior to registration)
-
RANDOMIZATION OR ASSIGNMENT TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3
-
Patients must have an ECOG performance status of 0-2
-
Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging bone marrow (BM) aspirate and biopsy
-
Patients must have resolved any serious infectious complications related to therapy
-
Any significant medical complications related to therapy must have resolved
-
Direct or total bilirubin < 1.5 x ULN (unless related to Gilbert's or Meulengracht's syndrome); the values must be obtained within 48 hours prior to randomization
-
Serum creatinine < 1.5 x ULN; the values must be obtained within 48 hours prior to randomization
-
Bone marrow aspirates must be submitted for centralized minimal residual disease (MRD) assessment performed by the ECOG-ACRIN Leukemia Translational Research Laboratory
-
MRD results will be reported to the submitting institution
-
NOTE: FOR MRD ASSESSMENTS, AN ASPIRATE FROM A SEPARATE BONE MARROW ASPIRATION SITE MUST BE SUBMITTED (THE NEEDLE CAN BE RE-DIRECTED THROUGH THE SAME SKIN PUNCTURE SITE); ONLY SUBMIT ASPIRATES FROM THE FIRST PULL OF AN ASPIRATION SITE FOR MRD TESTING; DO NOT SUBMIT SAMPLES FROM THE SECOND OR THIRD PULL OF THE SAME ASPIRATION SITE
-
In B-lineage ALL, MRD levels in peripheral blood or from a dilute marrow aspiration can be 300% lower, on average, than those in bone marrow at a given time point; submitting a first pull from a separate aspiration site will ensure that MRD determinations used in randomization and trial interpretation are accurate
- NOTE: failure to submit bone marrow aspirates will result in a major violation at the time of an audit
-
-
CRITERIA FOR ALLOGENEIC TRANSPLANTATION
-
A suitable donor must be identified; there are no restrictions on donor type and can include a matched sibling, a matched or mismatched unrelated donor, a family haplotype matched donor or a cord blood donor (single or double)
-
Patients should meet the eligibility criteria for RANDOMIZATION OR ASSIGNMENT TO BLINATUMOMAB OR NO BLINATUMOMAB-STEP 3
-
Patients must be considered reliable enough to comply with the medication regimen and follow-up, and have social support necessary to allow this compliance
-
CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have an ECOG performance status of 0-3
-
CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging BM aspirate and biopsy
-
CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Patients must have resolved any serious infectious complications related to therapy
-
CRITERIA FOR MAINTENANCE THERAPY-STEP 4: Any significant medical complications related to therapy must have resolved
Exclusion Criteria:
- Mature B ALL (Burkitt's-like leukemia) is excluded from enrollment in this trial; pre-study bone marrow biopsy and aspirate must be completed =< 1 week prior to registration
- Patient must not have a concurrent active malignancy for which they are receiving treatment
- Patient must not have intercurrent organ damage or medical problems that will jeopardize the outcome of therapy (i.e., psychiatric disorder, drug abuse, pregnancy)
- Patient must not have an antecedent hematologic disorder
- Patient must not have a history or presence of clinically relevant central nervous system (CNS) pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia; Parkinson's disease, cerebellar disease, organic brain syndrome, psychosis, or other significant CNS abnormalities
- Patient must not have an active uncontrolled infection
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Arm I (blinatumomab, chemotherapy)
See Detailed Description |
Given IV
Andra namn:
Given PO
Andra namn:
Undergo bone marrow biopsy
Andra namn:
Undergo blood sample collection
Andra namn:
Given IV
Andra namn:
Given IV
Andra namn:
Given IV
Andra namn:
Given PO
Andra namn:
Undergo allogeneic hematopoietic SCT
Andra namn:
Given IV
Andra namn:
Undergo bone marrow aspiration Given IT, IV, or SC
Andra namn:
Given IV
Andra namn:
Given IV
Andra namn:
Given IV
Andra namn:
Given IV or PO
Andra namn:
Undergo lumbar puncture
Andra namn:
Given PO
Andra namn:
Given PO, IT or IV
Andra namn:
Given IM or IV
Andra namn:
Undergo x-ray imaging
Andra namn:
|
|
Aktiv komparator: Arm II (chemotherapy)
See Detailed Description |
Given IV
Andra namn:
Given PO
Andra namn:
Undergo bone marrow biopsy
Andra namn:
Undergo blood sample collection
Andra namn:
Given IV
Andra namn:
Given IV
Andra namn:
Given IV
Andra namn:
Given PO
Andra namn:
Undergo allogeneic hematopoietic SCT
Andra namn:
Undergo bone marrow aspiration Given IT, IV, or SC
Andra namn:
Given IV
Andra namn:
Given IV
Andra namn:
Given IV
Andra namn:
Given IV or PO
Andra namn:
Undergo lumbar puncture
Andra namn:
Given PO
Andra namn:
Given PO, IT or IV
Andra namn:
Given IM or IV
Andra namn:
Undergo x-ray imaging
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Overall Survival (OS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy
Tidsram: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
Overall survival is defined as the time from randomization to death of any cause. |
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Relapse-free Survival (RFS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy
Tidsram: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
RFS was defined as time from randomization to relapse or to death without documentation of relapse. Patients without events were censored at the date of last disease assessment. Relapse/Persistent Disease Persistent disease/Relapse following complete remission (CR)/complete remission incomplete (CRi) is defined as:
|
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
|
RFS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy
Tidsram: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
RFS was defined as time from end of 2 cycles of blinatumomab to relapse or to death without documentation of relapse. Patients without events were censored at the date of last disease assessment. Relapse/Persistent Disease Persistent disease/Relapse following complete remission (CR)/complete remission incomplete (CRi) is defined as:
|
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
|
OS Among of Those Who Are MRD+ at Randomization and Then Convert to MRD- After 2 Cycles of Blinatumomab to Those Patients Who Are MRD- at Randomization and Remain MRD- After 2 Cycles of Blinatumomab or Consolidation Chemotherapy
Tidsram: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
OS was defined as time from end of 2 cycles of blinatumomab to death of any cause |
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
|
OS Among MRD Negative Patients Who Proceed to Allogeneic Transplant on Study
Tidsram: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
OS was defined as time from allogeneic transplant to death of any cause. |
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
To Determine Differences in MRD Kinetics Among Patients With the BCR/ABL1-like B-lineage ALL, and to Compare the OS (and RFS) of Patients With BCR-ABL-like Phenotype With Those Without BCR-ABLlike Phenotype
Tidsram: Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
To determine differences in MRD kinetics among patients with the BCR/ABL1-like B-lineage ALL, and to compare the OS (and RFS) of patients with BCR-ABL-like phenotype with those without BCR-ABLlike phenotype |
Assessed every 3 months for 2 years, then every 6 months for 3 years, then annually for 5 years
|
|
Incidence of Anti-blinatumomab Antibody Formation
Tidsram: Assessed at baseline, end of 2 cycles of blinatumomab, end of 4 cycles of blinatumomab, and end of blinatumomab treatment
|
To evaluate the incidence of anti-blinatumomab antibody formation |
Assessed at baseline, end of 2 cycles of blinatumomab, end of 4 cycles of blinatumomab, and end of blinatumomab treatment
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Mark R Litzow, ECOG-ACRIN Cancer Research Group
Publikationer och användbara länkar
Allmänna publikationer
- Seftel MD. Hyper-CVAD: a regimen for all seasons. Lancet Haematol. 2020 Jul;7(7):e501-e502. doi: 10.1016/S2352-3026(20)30179-4. No abstract available.
- Litzow MR, Sun Z, Mattison RJ, Paietta EM, Roberts KG, Zhang Y, Racevskis J, Lazarus HM, Rowe JM, Arber DA, Wieduwilt MJ, Liedtke M, Bergeron J, Wood BL, Zhao Y, Wu G, Chang TC, Zhang W, Pratz KW, Dinner SN, Frey N, Gore SD, Bhatnagar B, Atallah EL, Uy GL, Jeyakumar D, Lin TL, Willman CL, DeAngelo DJ, Patel SB, Elliott MA, Advani AS, Tzachanis D, Vachhani P, Bhave RR, Sharon E, Little RF, Erba HP, Stone RM, Luger SM, Mullighan CG, Tallman MS. Blinatumomab for MRD-Negative Acute Lymphoblastic Leukemia in Adults. N Engl J Med. 2024 Jul 25;391(4):320-333. doi: 10.1056/NEJMoa2312948.
- Zhong X, Roberts KG, Wei H, Sun Z, Montefiori LE, Kumar A, Iacobucci I, Baviskar P, Gao Q, Polonen P, Pruett-Miller SM, Schreiber RM, Chang TC, Zhang W, Lei S, Rampersaud E, Fan Y, Wu G, Mattison RJ, Zhang Y, Racevskis J, Lazarus HM, Rowe JM, Arber DA, Wieduwilt MJ, Abou Mourad Y, Shami PJ, Baer MR, Asch AS, O'Dwyer KM, Hall A, Liedtke M, Bergeron J, Wood BL, Pratz KW, Dinner SN, Frey NV, Gore SD, Bhatnagar B, Atallah EL, Uy GL, Jeyakumar D, Lin TL, Willman CL, Podoltsev NA, DeAngelo DJ, Patel S, Elliott MA, Advani AS, Tzachanis D, Vachhani P, Bhave RR, Sharon E, Little RF, Erba HP, Stone RM, Tallman MS, Yang JJ, Luger SM, Paietta E, Litzow MR, Mullighan CG. Genomic drivers of leukemia and blinatumomab response in adult acute lymphoblastic leukemia - the ECOG-ACRIN E1910 study. Blood. 2026 Oct 5:blood.2026033793. doi: 10.1182/blood.2026033793. Online ahead of print.
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Studieregistreringsdatum
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Först inskickad som uppfyllde QC-kriterierna
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Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer
- Immunsystemets sjukdomar
- Infektioner
- Virussjukdomar
- Neoplasmer efter histologisk typ
- Hematologiska sjukdomar
- DNA-virusinfektioner
- Lymfatiska sjukdomar
- Lymfoproliferativa störningar
- Immunproliferativa störningar
- Lymfom, icke-Hodgkin
- Lymfom, B-cell
- Lymfom
- Leukemi, lymfoid
- Leukemi
- Epstein-Barr-virusinfektioner
- Herpesviridae-infektioner
- Tumörvirusinfektioner
- Hemiska och lymfsjukdomar
- Prekursorcellslymfoblastisk leukemi-lymfom
- Burkitt lymfom
- Aminosyror, peptider och proteiner
- Proteiner
- Svavelföreningar
- Organiska kemikalier
- Heterocykliska föreningar, 1-ring
- Heterocykliska föreningar
- Heterocykliska föreningar, 2-ring
- Heterocykliska föreningar, smältring
- Undersökningstekniker
- Terapeutik
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Punktering
- Kirurgiska ingrepp, operativ
- Cytologiska tekniker
- Nukleinsyror, nukleotider och nukleosider
- Cytodiagnos
- Kolväten
- Kolväten, cykliska
- Kolhydrater
- Fysiska fenomen
- Alkaloider
- Podofyllotoxin
- Tetrahydronaftaler
- Naftalar
- Polycykliska aromatiska kolväten
- Kolväten, aromatisk
- Polycykliska föreningar
- Glukosider
- Glykosider
- Transplantation
- Utrustning och förnödenheter
- Enzymer och koenzymer
- Förenad
- Antikroppar, monoklonal
- Antikroppar
- Immunglobuliner
- Immunoproteiner
- Blodproteiner
- Serumglobuliner
- Globuliner
- Puriner
- Cytidin
- Pyrimidin nukleosider
- Pyrimidiner
- Graviditet
- Graviditet
- Steroider
- Fusion-ringföreningar
- Steroider, fluorerade
- Bensiverivat
- Diagnostiska tekniker, kirurgiska
- Sulfonsyror
- Svavelsyror
- Fosforamidsen
- Kväve senapsföreningar
- Senapsföreningar
- Kolväten, halogenerad
- Fosforamider
- Organofosforföreningar
- Nukleosider
- Formyltetrahydrofolat
- Tetrahydrofolat
- Folinsyra
- Pteriner
- Pteridiner
- Graviditet
- Gravidioder
- Vinca alkaloider
- Secologanin tryptaminalkaloider
- Indolalkaloider
- Indolizidiner
- Indoliziner
- Arabinonukleosider
- Aminopterin
- Anthracykliner
- Naftakener
- Aminoglykosider
- Koenzymer
- Elektromagnetiska fenomen
- Magnetfenomen
- Antikroppar, monoklonal, murin härledd
- Celltransplantation
- Cell- och vävnadsbaserad terapi
- Biologisk behandling
- Diagnostiska tekniker, neurologiska
- Elektromagnetisk strålning
- Strålning
- Strålning, joniserande
- Bensensulfonater
- Arylsulfonater
- Arylsulfonsyror
- Sulfhydrylföreningar
- Rituximab
- Dexametason
- Metotrexat
- Prednison
- Cyklofosfamid
- Cytarabin
- Etoposid
- Leucovorin
- Vincristine
- Daunorubicin
- Merkaptopurin
- Kalciumdobesilat
- Biopsi
- Provhantering
- blinatumomab
- Stamcellstransplantation
- Ryggpunkter
- dexametason 21-fosfat
- Röntgenstrålar
- Ct-p10
- deltacortene
- prednyliden
- N, N-dicyklohexyl-isoborneol-10-sulfonamid
- azatiopurin
- merfos
- pegaspargas
- Fantom, avbildning
- auricularum
- dexametasonacetat
Andra studie-ID-nummer
- NCI-2013-02229
- U10CA180820 (U.S.S. NIH-anslag/kontrakt)
- U24CA196172 (U.S.S. NIH-anslag/kontrakt)
- U10CA021115 (U.S.S. NIH-anslag/kontrakt)
- NCI-2013-02229 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- ECOG-E1910
- E1910 (Annan identifierare: CTEP)
- PE1910_A08PAMDREVW01
- E1910 (Annan identifierare: ECOG-ACRIN Cancer Research Group)
Läkemedels- och apparatinformation, studiedokument
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