Chemioterapia skojarzona z Blinatumomabem lub bez niego w leczeniu pacjentów z nowo rozpoznaną ostrą białaczką limfoblastyczną BCR-ABL-ujemną
Randomizowane badanie fazy III dotyczące stosowania blinatumomabu u nowo zdiagnozowanej ostrej białaczki limfoblastycznej linii B z ujemnym wynikiem BCR-ABL u dorosłych
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.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
- Lek: Cyclophosphamide
- Lek: Prednisone
- Procedura: Bone Marrow Biopsy
- Procedura: Biospecimen Collection
- Biologiczny: Rituximab
- Lek: Vincristine
- Lek: Vincristine Sulfate
- Lek: Dexamethasone
- Procedura: Allogeneic Hematopoietic Stem Cell Transplantation
- Biologiczny: Blinatumomab
- Procedura: Bone Marrow Aspiration
- Lek: Cytarabine
- Lek: Daunorubicin
- Lek: Daunorubicin Hydrochloride
- Lek: Etoposide
- Lek: Leucovorin Calcium
- Procedura: Lumbar Puncture
- Lek: Mercaptopurine
- Lek: Methotrexate
- Lek: Pegaspargase
- Procedura: X-Ray Imaging
Szczegółowy opis
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.
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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-
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Haifa, Izrael, 31096
- Rambam Medical Center
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Jerusalem, Izrael, 91031
- Shaare Zedek Medical Center
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Alberta
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Calgary, Alberta, Kanada, T2N 5G2
- Arthur J E Child Comprehensive Cancer Centre
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British Columbia
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Vancouver, British Columbia, Kanada, V5Z 3P1
- Clinical Research Unit at Vancouver Coastal Health Authority
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3H 2Y9
- QEII Health Sciences Centre/Nova Scotia Health Authority
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Ontario
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Kingston, Ontario, Kanada, K7L 2V7
- Kingston Health Sciences Centre
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Quebec
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Montreal, Quebec, Kanada, H1T 2M4
- CIUSSSEMTL-Hopital Maisonneuve-Rosemont
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Saskatchewan
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Regina, Saskatchewan, Kanada, S4T 7T1
- Allan Blair Cancer Centre
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-
-
-
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Bayamón, Portoryko, 00959-5060
- Cancer Center-Metro Medical Center Bayamon
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Manati, Portoryko, 00674
- Doctors Cancer Center
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San Juan, Portoryko, 00917
- San Juan Community Oncology Group
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San Juan, Portoryko, 00927
- Centro Comprensivo de Cancer de UPR
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San Juan, Portoryko, 00936
- San Juan City Hospital
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Alabama
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Birmingham, Alabama, Stany Zjednoczone, 35233
- University of Alabama at Birmingham Cancer Center
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Alaska
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Anchorage, Alaska, Stany Zjednoczone, 98508
- Anchorage Associates in Radiation Medicine
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Alaska Breast Care and Surgery LLC
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Alaska Oncology and Hematology LLC
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Alaska Women's Cancer Care
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Anchorage Oncology Centre
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Katmai Oncology Group
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Providence Alaska Medical Center
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Anchorage, Alaska, Stany Zjednoczone, 99504
- Anchorage Radiation Therapy Center
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Anchorage, Alaska, Stany Zjednoczone, 99508
- Alaska Regional Hospital
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Fairbanks, Alaska, Stany Zjednoczone, 99701
- Fairbanks Memorial Hospital
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Arizona
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Kingman, Arizona, Stany Zjednoczone, 86401
- Kingman Regional Medical Center
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Tucson, Arizona, Stany Zjednoczone, 85719
- Banner University Medical Center - Tucson
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Tucson, Arizona, Stany Zjednoczone, 85719
- University of Arizona Cancer Center-North Campus
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Arkansas
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Fort Smith, Arkansas, Stany Zjednoczone, 72903
- Mercy Hospital Fort Smith
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Little Rock, Arkansas, Stany Zjednoczone, 72205
- University of Arkansas for Medical Sciences
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California
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Arroyo Grande, California, Stany Zjednoczone, 93420
- PCR Oncology
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Burbank, California, Stany Zjednoczone, 91505
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
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Clovis, California, Stany Zjednoczone, 93611
- Community Cancer Institute
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Clovis, California, Stany Zjednoczone, 93611
- University Oncology Associates
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La Jolla, California, Stany Zjednoczone, 92093
- UC San Diego Moores Cancer Center
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Orange, California, Stany Zjednoczone, 92868
- UC Irvine Health/Chao Family Comprehensive Cancer Center
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Palo Alto, California, Stany Zjednoczone, 94304
- Stanford Cancer Institute Palo Alto
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Colorado
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Aurora, Colorado, Stany Zjednoczone, 80012
- Rocky Mountain Cancer Centers-Aurora
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Aurora, Colorado, Stany Zjednoczone, 80012
- The Medical Center of Aurora
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Boulder, Colorado, Stany Zjednoczone, 80303
- Boulder Community Foothills Hospital
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Boulder, Colorado, Stany Zjednoczone, 80304
- Rocky Mountain Cancer Centers-Boulder
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Denver, Colorado, Stany Zjednoczone, 80218
- Presbyterian - Saint Lukes Medical Center - Health One
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Denver, Colorado, Stany Zjednoczone, 80220
- Rose Medical Center
-
Denver, Colorado, Stany Zjednoczone, 80218
- Rocky Mountain Cancer Centers-Midtown
-
Denver, Colorado, Stany Zjednoczone, 80220
- Rocky Mountain Cancer Centers-Rose
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Denver, Colorado, Stany Zjednoczone, 80218
- Colorado Blood Cancer Institute
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Denver, Colorado, Stany Zjednoczone, 80204
- Cancer Center of Colorado at Sloan's Lake
-
Denver, Colorado, Stany Zjednoczone, 80209
- The Women's Imaging Center
-
Denver, Colorado, Stany Zjednoczone, 80206
- National Jewish Health-Main Campus
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Denver, Colorado, Stany Zjednoczone, 80220
- Western Surgical Care
-
Denver, Colorado, Stany Zjednoczone, 80218
- Saint Joseph Hospital - Cancer Centers of Colorado
-
Englewood, Colorado, Stany Zjednoczone, 80113
- Mountain Blue Cancer Care Center - Swedish
-
Englewood, Colorado, Stany Zjednoczone, 80113
- Swedish Medical Center
-
Golden, Colorado, Stany Zjednoczone, 80401
- National Jewish Health-Western Hematology Oncology
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Grand Junction, Colorado, Stany Zjednoczone, 81501
- Saint Mary's Hospital and Regional Medical Center
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Grand Junction, Colorado, Stany Zjednoczone, 81505
- Grand Valley Oncology
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Greeley, Colorado, Stany Zjednoczone, 80631
- Banner North Colorado Medical Center
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Lafayette, Colorado, Stany Zjednoczone, 80026
- Good Samaritan Hospital - Cancer Centers of Colorado
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Littleton, Colorado, Stany Zjednoczone, 80120
- Rocky Mountain Cancer Centers-Littleton
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Lone Tree, Colorado, Stany Zjednoczone, 80124
- Sky Ridge Medical Center
-
Lone Tree, Colorado, Stany Zjednoczone, 80124
- Rocky Mountain Cancer Centers-Sky Ridge
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Loveland, Colorado, Stany Zjednoczone, 80539
- Banner North Colorado Medical Center - Loveland Campus
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Thornton, Colorado, Stany Zjednoczone, 80260
- National Jewish Health-Northern Hematology Oncology
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Wheat Ridge, Colorado, Stany Zjednoczone, 80401
- Intermountain Health Lutheran Hospital
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Connecticut
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Hartford, Connecticut, Stany Zjednoczone, 06105
- Smilow Cancer Hospital Care Center at Saint Francis
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New Haven, Connecticut, Stany Zjednoczone, 06520
- Yale University
-
Torrington, Connecticut, Stany Zjednoczone, 06790
- Smilow Cancer Hospital-Torrington Care Center
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District of Columbia
-
Washington D.C., District of Columbia, Stany Zjednoczone, 20016
- Sibley Memorial Hospital
-
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Florida
-
Coral Springs, Florida, Stany Zjednoczone, 33065
- UM Sylvester Comprehensive Cancer Center at Coral Springs
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Deerfield Beach, Florida, Stany Zjednoczone, 33442
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach
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Hollywood, Florida, Stany Zjednoczone, 33021
- UM Sylvester Comprehensive Cancer Center at Hollywood
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Jacksonville, Florida, Stany Zjednoczone, 32207
- Baptist MD Anderson Cancer Center
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Miami, Florida, Stany Zjednoczone, 33136
- University of Miami Miller School of Medicine-Sylvester Cancer Center
-
Miami, Florida, Stany Zjednoczone, 33176
- UM Sylvester Comprehensive Cancer Center at Kendall
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Plantation, Florida, Stany Zjednoczone, 33324
- UM Sylvester Comprehensive Cancer Center at Plantation
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Weston, Florida, Stany Zjednoczone, 33331
- Cleveland Clinic-Weston
-
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Georgia
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Atlanta, Georgia, Stany Zjednoczone, 30322
- Emory University Hospital/Winship Cancer Institute
-
Atlanta, Georgia, Stany Zjednoczone, 30342
- Northside Hospital
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Idaho
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Boise, Idaho, Stany Zjednoczone, 83706
- Saint Alphonsus Cancer Care Center-Boise
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Boise, Idaho, Stany Zjednoczone, 83712
- Saint Luke's Cancer Institute - Boise
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Caldwell, Idaho, Stany Zjednoczone, 83605
- Saint Alphonsus Cancer Care Center-Caldwell
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Coeur d'Alene, Idaho, Stany Zjednoczone, 83814
- Kootenai Health - Coeur d'Alene
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Emmett, Idaho, Stany Zjednoczone, 83617
- Walter Knox Memorial Hospital
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Fruitland, Idaho, Stany Zjednoczone, 83619
- Saint Luke's Cancer Institute - Fruitland
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Meridian, Idaho, Stany Zjednoczone, 83642
- Idaho Urologic Institute-Meridian
-
Meridian, Idaho, Stany Zjednoczone, 83642
- Saint Luke's Cancer Institute - Meridian
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Nampa, Idaho, Stany Zjednoczone, 83687
- Saint Alphonsus Cancer Care Center-Nampa
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Nampa, Idaho, Stany Zjednoczone, 83687
- Saint Luke's Cancer Institute - Nampa
-
Post Falls, Idaho, Stany Zjednoczone, 83854
- Kootenai Clinic Cancer Services - Post Falls
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Sandpoint, Idaho, Stany Zjednoczone, 83864
- Kootenai Clinic Cancer Services - Sandpoint
-
Twin Falls, Idaho, Stany Zjednoczone, 83301
- Saint Luke's Cancer Institute - Twin Falls
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Illinois
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Bloomington, Illinois, Stany Zjednoczone, 61704
- Illinois CancerCare-Bloomington
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Bloomington, Illinois, Stany Zjednoczone, 61701
- OSF Saint Joseph Medical Center
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Canton, Illinois, Stany Zjednoczone, 61520
- Illinois CancerCare-Canton
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Carbondale, Illinois, Stany Zjednoczone, 62902
- Memorial Hospital of Carbondale
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Carterville, Illinois, Stany Zjednoczone, 62918
- SIH Cancer Institute
-
Carthage, Illinois, Stany Zjednoczone, 62321
- Illinois CancerCare-Carthage
-
Centralia, Illinois, Stany Zjednoczone, 62801
- Centralia Oncology Clinic
-
Chicago, Illinois, Stany Zjednoczone, 60611
- Northwestern University
-
Chicago, Illinois, Stany Zjednoczone, 60637
- University of Chicago Comprehensive Cancer Center
-
Chicago, Illinois, Stany Zjednoczone, 60612
- University of Illinois
-
Chicago, Illinois, Stany Zjednoczone, 60608
- Mount Sinai Hospital Medical Center
-
Decatur, Illinois, Stany Zjednoczone, 62526
- Decatur Memorial Hospital
-
Decatur, Illinois, Stany Zjednoczone, 62526
- Cancer Care Specialists of Illinois - Decatur
-
Dixon, Illinois, Stany Zjednoczone, 61021
- Illinois CancerCare-Dixon
-
Effingham, Illinois, Stany Zjednoczone, 62401
- Crossroads Cancer Center
-
Eureka, Illinois, Stany Zjednoczone, 61530
- Illinois CancerCare-Eureka
-
Evanston, Illinois, Stany Zjednoczone, 60201
- NorthShore University HealthSystem-Evanston Hospital
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Galesburg, Illinois, Stany Zjednoczone, 61401
- Western Illinois Cancer Treatment Center
-
Galesburg, Illinois, Stany Zjednoczone, 61401
- Illinois CancerCare-Galesburg
-
Glenview, Illinois, Stany Zjednoczone, 60026
- NorthShore University HealthSystem-Glenbrook Hospital
-
Highland Park, Illinois, Stany Zjednoczone, 60035
- NorthShore University HealthSystem-Highland Park Hospital
-
Highland Park, Illinois, Stany Zjednoczone, 60035
- Hematology Oncology Associates of Illinois-Highland Park
-
Kankakee, Illinois, Stany Zjednoczone, 60901
- Presence Saint Mary's Hospital
-
Kewanee, Illinois, Stany Zjednoczone, 61443
- Illinois CancerCare-Kewanee Clinic
-
Libertyville, Illinois, Stany Zjednoczone, 60048
- AMG Libertyville - Oncology
-
Macomb, Illinois, Stany Zjednoczone, 61455
- Illinois CancerCare-Macomb
-
Maywood, Illinois, Stany Zjednoczone, 60153
- Loyola University Medical Center
-
Mount Vernon, Illinois, Stany Zjednoczone, 62864
- SSM Health Good Samaritan
-
Niles, Illinois, Stany Zjednoczone, 60714
- Illinois Cancer Specialists-Niles
-
O'Fallon, Illinois, Stany Zjednoczone, 62269
- Cancer Care Center of O'Fallon
-
Ottawa, Illinois, Stany Zjednoczone, 61350
- Illinois CancerCare-Ottawa Clinic
-
Ottawa, Illinois, Stany Zjednoczone, 61350
- Radiation Oncology of Northern Illinois
-
Pekin, Illinois, Stany Zjednoczone, 61554
- Illinois CancerCare-Pekin
-
Pekin, Illinois, Stany Zjednoczone, 61554
- OSF Saint Francis Radiation Oncology at Pekin
-
Peoria, Illinois, Stany Zjednoczone, 61636
- Methodist Medical Center of Illinois
-
Peoria, Illinois, Stany Zjednoczone, 61637
- OSF Saint Francis Medical Center
-
Peoria, Illinois, Stany Zjednoczone, 61615
- Illinois CancerCare-Peoria
-
Peoria, Illinois, Stany Zjednoczone, 61615
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
-
Peru, Illinois, Stany Zjednoczone, 61354
- Illinois CancerCare-Peru
-
Peru, Illinois, Stany Zjednoczone, 61354
- Valley Radiation Oncology
-
Princeton, Illinois, Stany Zjednoczone, 61356
- Illinois CancerCare-Princeton
-
Skokie, Illinois, Stany Zjednoczone, 60076
- Hematology Oncology Associates of Illinois - Skokie
-
Skokie, Illinois, Stany Zjednoczone, 60076
- North Shore Medical Center
-
Springfield, Illinois, Stany Zjednoczone, 62702
- Southern Illinois University School of Medicine
-
Springfield, Illinois, Stany Zjednoczone, 62702
- Springfield Clinic
-
Springfield, Illinois, Stany Zjednoczone, 62702
- Central Illinois Hematology Oncology Center
-
Springfield, Illinois, Stany Zjednoczone, 62781
- Springfield Memorial Hospital
-
Swansea, Illinois, Stany Zjednoczone, 62226
- Southwest Illinois Health Services LLP
-
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Indiana
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Fort Wayne, Indiana, Stany Zjednoczone, 46805
- Parkview Hospital Randallia
-
Fort Wayne, Indiana, Stany Zjednoczone, 46845
- Parkview Regional Medical Center
-
Indianapolis, Indiana, Stany Zjednoczone, 46237
- Franciscan Health Indianapolis
-
Mooresville, Indiana, Stany Zjednoczone, 46158
- Franciscan Health Mooresville
-
Richmond, Indiana, Stany Zjednoczone, 47374
- Reid Health
-
-
Iowa
-
Ames, Iowa, Stany Zjednoczone, 50010
- Mary Greeley Medical Center
-
Ames, Iowa, Stany Zjednoczone, 50010
- McFarland Clinic - Ames
-
Boone, Iowa, Stany Zjednoczone, 50036
- McFarland Clinic - Boone
-
Fort Dodge, Iowa, Stany Zjednoczone, 50501
- McFarland Clinic - Trinity Cancer Center
-
Jefferson, Iowa, Stany Zjednoczone, 50129
- McFarland Clinic - Jefferson
-
Marshalltown, Iowa, Stany Zjednoczone, 50158
- McFarland Clinic - Marshalltown
-
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Kansas
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Chanute, Kansas, Stany Zjednoczone, 66720
- Cancer Center of Kansas - Chanute
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Dodge City, Kansas, Stany Zjednoczone, 67801
- Cancer Center of Kansas - Dodge City
-
El Dorado, Kansas, Stany Zjednoczone, 67042
- Cancer Center of Kansas - El Dorado
-
Fort Scott, Kansas, Stany Zjednoczone, 66701
- Cancer Center of Kansas - Fort Scott
-
Garden City, Kansas, Stany Zjednoczone, 67846
- Central Care Cancer Center - Garden City
-
Great Bend, Kansas, Stany Zjednoczone, 67530
- Central Care Cancer Center - Great Bend
-
Independence, Kansas, Stany Zjednoczone, 67301
- Cancer Center of Kansas-Independence
-
Kansas City, Kansas, Stany Zjednoczone, 66160
- University of Kansas Cancer Center
-
Kingman, Kansas, Stany Zjednoczone, 67068
- Cancer Center of Kansas-Kingman
-
Lawrence, Kansas, Stany Zjednoczone, 66044
- Lawrence Memorial Hospital
-
Lenexa, Kansas, Stany Zjednoczone, 66219
- Kansas Institute of Medicine Cancer and Blood Center
-
Lenexa, Kansas, Stany Zjednoczone, 66219
- Minimally Invasive Surgery Hospital
-
Liberal, Kansas, Stany Zjednoczone, 67905
- Cancer Center of Kansas-Liberal
-
Manhattan, Kansas, Stany Zjednoczone, 66502
- Cancer Center of Kansas-Manhattan
-
McPherson, Kansas, Stany Zjednoczone, 67460
- Cancer Center of Kansas - McPherson
-
Newton, Kansas, Stany Zjednoczone, 67114
- Cancer Center of Kansas - Newton
-
Olathe, Kansas, Stany Zjednoczone, 66061
- The University of Kansas Cancer Center - Olathe
-
Overland Park, Kansas, Stany Zjednoczone, 66209
- Menorah Medical Center
-
Overland Park, Kansas, Stany Zjednoczone, 66213
- Saint Luke's South Hospital
-
Parsons, Kansas, Stany Zjednoczone, 67357
- Cancer Center of Kansas - Parsons
-
Pratt, Kansas, Stany Zjednoczone, 67124
- Cancer Center of Kansas - Pratt
-
Salina, Kansas, Stany Zjednoczone, 67401
- Cancer Center of Kansas - Salina
-
Wellington, Kansas, Stany Zjednoczone, 67152
- Cancer Center of Kansas - Wellington
-
Westwood, Kansas, Stany Zjednoczone, 66205
- University of Kansas Hospital-Westwood Cancer Center
-
Wichita, Kansas, Stany Zjednoczone, 67214
- Ascension Via Christi Hospitals Wichita
-
Wichita, Kansas, Stany Zjednoczone, 67208
- Cancer Center of Kansas-Wichita Medical Arts Tower
-
Wichita, Kansas, Stany Zjednoczone, 67214
- Cancer Center of Kansas - Wichita
-
Wichita, Kansas, Stany Zjednoczone, 67208
- Associates In Womens Health
-
Wichita, Kansas, Stany Zjednoczone, 67214
- Wesley Medical Center
-
Winfield, Kansas, Stany Zjednoczone, 67156
- Cancer Center of Kansas - Winfield
-
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Kentucky
-
Crestview Hills, Kentucky, Stany Zjednoczone, 41017
- Oncology Hematology Care Inc-Crestview
-
Louisville, Kentucky, Stany Zjednoczone, 40202
- The James Graham Brown Cancer Center at University of Louisville
-
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Louisiana
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Baton Rouge, Louisiana, Stany Zjednoczone, 70809
- Ochsner Health Center-Summa
-
Baton Rouge, Louisiana, Stany Zjednoczone, 70816
- Medical Center of Baton Rouge
-
Baton Rouge, Louisiana, Stany Zjednoczone, 70836
- Ochsner High Grove
-
Monroe, Louisiana, Stany Zjednoczone, 71202
- Ochsner LSU Health Monroe Medical Center
-
New Orleans, Louisiana, Stany Zjednoczone, 70121
- Ochsner Medical Center Jefferson
-
Shreveport, Louisiana, Stany Zjednoczone, 71103
- LSU Health Sciences Center at Shreveport
-
-
Maine
-
Bangor, Maine, Stany Zjednoczone, 04401
- Eastern Maine Medical Center
-
Brewer, Maine, Stany Zjednoczone, 04412
- Lafayette Family Cancer Center-EMMC
-
-
Maryland
-
Baltimore, Maryland, Stany Zjednoczone, 21287
- Johns Hopkins University/Sidney Kimmel Cancer Center
-
Baltimore, Maryland, Stany Zjednoczone, 21201
- University of Maryland/Greenebaum Cancer Center
-
Bethesda, Maryland, Stany Zjednoczone, 20889-5600
- Walter Reed National Military Medical Center
-
-
Massachusetts
-
Boston, Massachusetts, Stany Zjednoczone, 02215
- Beth Israel Deaconess Medical Center
-
Boston, Massachusetts, Stany Zjednoczone, 02215
- Dana-Farber Cancer Institute
-
Boston, Massachusetts, Stany Zjednoczone, 02114
- Massachusetts General Hospital Cancer Center
-
-
Michigan
-
Adrian, Michigan, Stany Zjednoczone, 49221
- Bixby Medical Center
-
Adrian, Michigan, Stany Zjednoczone, 49221
- Hickman Cancer Center
-
Ann Arbor, Michigan, Stany Zjednoczone, 48106
- Trinity Health Saint Joseph Mercy Hospital Ann Arbor
-
Battle Creek, Michigan, Stany Zjednoczone, 49017
- Bronson Battle Creek
-
Brownstown, Michigan, Stany Zjednoczone, 48183
- Henry Ford Cancer Institute-Downriver
-
Clinton Township, Michigan, Stany Zjednoczone, 48038
- Henry Ford Macomb Hospital-Clinton Township
-
Dearborn, Michigan, Stany Zjednoczone, 48126
- Henry Ford Medical Center-Fairlane
-
Dearborn, Michigan, Stany Zjednoczone, 48124
- Corewell Health Dearborn Hospital
-
Detroit, Michigan, Stany Zjednoczone, 48202
- Henry Ford Hospital
-
Detroit, Michigan, Stany Zjednoczone, 48201
- Wayne State University/Karmanos Cancer Institute
-
Detroit, Michigan, Stany Zjednoczone, 48236
- Henry Ford Health Saint John Hospital
-
Escanaba, Michigan, Stany Zjednoczone, 49829
- OSF Saint Francis Hospital and Medical Group
-
Farmington Hills, Michigan, Stany Zjednoczone, 48334
- Weisberg Cancer Treatment Center
-
Farmington Hills, Michigan, Stany Zjednoczone, 48336
- Corewell Health Farmington Hills Hospital
-
Flint, Michigan, Stany Zjednoczone, 48503
- Hurley Medical Center
-
Flint, Michigan, Stany Zjednoczone, 48503
- Genesys Hurley Cancer Institute
-
Grand Rapids, Michigan, Stany Zjednoczone, 49503
- Trinity Health Grand Rapids Hospital
-
Grand Rapids, Michigan, Stany Zjednoczone, 49503
- Corewell Health Grand Rapids Hospitals - Butterworth Hospital
-
Grand Rapids, Michigan, Stany Zjednoczone, 49503
- Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
-
Grosse Pointe, Michigan, Stany Zjednoczone, 48230
- William Beaumont Hospital-Grosse Pointe
-
Jackson, Michigan, Stany Zjednoczone, 49201
- Allegiance Health
-
Kalamazoo, Michigan, Stany Zjednoczone, 49007
- West Michigan Cancer Center
-
Kalamazoo, Michigan, Stany Zjednoczone, 49007
- Bronson Methodist Hospital
-
Kalamazoo, Michigan, Stany Zjednoczone, 49048
- Beacon Kalamazoo
-
Lansing, Michigan, Stany Zjednoczone, 48912
- University of Michigan Health - Sparrow Lansing
-
Livonia, Michigan, Stany Zjednoczone, 48154
- Trinity Health Saint Mary Mercy Livonia Hospital
-
Monroe, Michigan, Stany Zjednoczone, 48162
- Mercy Memorial Hospital
-
Monroe, Michigan, Stany Zjednoczone, 48162
- Toledo Clinic Cancer Centers-Monroe
-
Muskegon, Michigan, Stany Zjednoczone, 49444
- Trinity Health Muskegon Hospital
-
Niles, Michigan, Stany Zjednoczone, 49120
- Corewell Health Lakeland Hospitals - Niles Hospital
-
Norton Shores, Michigan, Stany Zjednoczone, 49444
- Cancer and Hematology Centers of Western Michigan - Norton Shores
-
Novi, Michigan, Stany Zjednoczone, 48377
- Henry Ford Medical Center-Columbus
-
Pontiac, Michigan, Stany Zjednoczone, 48341
- Trinity Health Saint Joseph Mercy Oakland Hospital
-
Port Huron, Michigan, Stany Zjednoczone, 48060
- Lake Huron Medical Center
-
Port Huron, Michigan, Stany Zjednoczone, 48060
- Huron Medical Center PC
-
Reed City, Michigan, Stany Zjednoczone, 49677
- Corewell Health Reed City Hospital
-
Roseville, Michigan, Stany Zjednoczone, 48066
- Michigan Cancer Specialists
-
Royal Oak, Michigan, Stany Zjednoczone, 48073
- Cancer Care Associates PC
-
Royal Oak, Michigan, Stany Zjednoczone, 48073
- Comprehensive Medical Center PLLC
-
Royal Oak, Michigan, Stany Zjednoczone, 48073
- Oakland Medical Group
-
Royal Oak, Michigan, Stany Zjednoczone, 48067
- Oakland Colon Rectal Associates
-
Royal Oak, Michigan, Stany Zjednoczone, 48073
- Hematology Oncology Consultants PC-Royal Oak
-
Royal Oak, Michigan, Stany Zjednoczone, 48073
- Corewell Health William Beaumont University Hospital
-
Saginaw, Michigan, Stany Zjednoczone, 48601
- MyMichigan Medical Center Saginaw
-
Saint Joseph, Michigan, Stany Zjednoczone, 49085
- Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
-
Saint Joseph, Michigan, Stany Zjednoczone, 49085
- Corewell Health Lakeland Hospitals - Saint Joseph Hospital
-
Sterling Heights, Michigan, Stany Zjednoczone, 48312
- Premier Hematology Oncology Care
-
Sterling Heights, Michigan, Stany Zjednoczone, 48314
- Mitchell Folbe MD PC
-
Traverse City, Michigan, Stany Zjednoczone, 49684
- Munson Medical Center
-
Troy, Michigan, Stany Zjednoczone, 48084
- Michigan Institute of Urology-Town Center
-
Troy, Michigan, Stany Zjednoczone, 48085
- Claudia BR Herke MD PC
-
Troy, Michigan, Stany Zjednoczone, 48098
- Hematology Oncology Consultants PC-Troy
-
Troy, Michigan, Stany Zjednoczone, 48085
- Corewell Health Beaumont Troy Hospital
-
Warren, Michigan, Stany Zjednoczone, 48093
- Henry Ford Health Warren Hospital
-
West Bloomfield, Michigan, Stany Zjednoczone, 48322
- Henry Ford West Bloomfield Hospital
-
Wyoming, Michigan, Stany Zjednoczone, 49519
- University of Michigan Health - West
-
-
Minnesota
-
Rochester, Minnesota, Stany Zjednoczone, 55905
- Mayo Clinic in Rochester
-
-
Missouri
-
Ballwin, Missouri, Stany Zjednoczone, 63011
- Mercy Oncology and Hematology - Clayton-Clarkson
-
Bolivar, Missouri, Stany Zjednoczone, 65613
- Central Care Cancer Center - Bolivar
-
Bonne Terre, Missouri, Stany Zjednoczone, 63628
- Parkland Health Center-Bonne Terre
-
Branson, Missouri, Stany Zjednoczone, 65616
- Cox Cancer Center Branson
-
Cape Girardeau, Missouri, Stany Zjednoczone, 63703
- Saint Francis Medical Center
-
Cape Girardeau, Missouri, Stany Zjednoczone, 63703
- Mercy Cancer Center - Cape Girardeau
-
City of Saint Peters, Missouri, Stany Zjednoczone, 63376
- Siteman Cancer Center at Saint Peters Hospital
-
Creve Coeur, Missouri, Stany Zjednoczone, 63141
- Siteman Cancer Center at West County Hospital
-
Farmington, Missouri, Stany Zjednoczone, 63640
- Parkland Health Center - Farmington
-
Independence, Missouri, Stany Zjednoczone, 64057
- Centerpoint Medical Center LLC
-
Jefferson City, Missouri, Stany Zjednoczone, 65109
- MU Health Care Goldschmidt Cancer Center
-
Joplin, Missouri, Stany Zjednoczone, 64804
- Freeman Health System
-
Joplin, Missouri, Stany Zjednoczone, 64804
- Mercy Hospital Joplin
-
Kansas City, Missouri, Stany Zjednoczone, 64111
- Saint Luke's Hospital of Kansas City
-
Kansas City, Missouri, Stany Zjednoczone, 64132
- Research Medical Center
-
Kansas City, Missouri, Stany Zjednoczone, 64118
- Heartland Hematology and Oncology Associates Incorporated
-
Lee's Summit, Missouri, Stany Zjednoczone, 64086
- Saint Luke's East - Lee's Summit
-
Liberty, Missouri, Stany Zjednoczone, 64068
- Liberty Hospital
-
Rolla, Missouri, Stany Zjednoczone, 65401
- Mercy Clinic-Rolla-Cancer and Hematology
-
Rolla, Missouri, Stany Zjednoczone, 65401
- Phelps Health Delbert Day Cancer Institute
-
Saint Joseph, Missouri, Stany Zjednoczone, 64506
- Heartland Regional Medical Center
-
Sainte Genevieve, Missouri, Stany Zjednoczone, 63670
- Sainte Genevieve County Memorial Hospital
-
Springfield, Missouri, Stany Zjednoczone, 65807
- CoxHealth South Hospital
-
Springfield, Missouri, Stany Zjednoczone, 65804
- Mercy Hospital Springfield
-
St Louis, Missouri, Stany Zjednoczone, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Stany Zjednoczone, 63129
- Siteman Cancer Center-South County
-
St Louis, Missouri, Stany Zjednoczone, 63131
- Missouri Baptist Medical Center
-
St Louis, Missouri, Stany Zjednoczone, 63109
- Mercy Infusion Center - Chippewa
-
St Louis, Missouri, Stany Zjednoczone, 63141
- Mercy Hospital Saint Louis
-
St Louis, Missouri, Stany Zjednoczone, 63128
- Mercy Hospital South
-
Sullivan, Missouri, Stany Zjednoczone, 63080
- Missouri Baptist Sullivan Hospital
-
Washington, Missouri, Stany Zjednoczone, 63090
- Mercy Hospital Washington
-
-
Montana
-
Anaconda, Montana, Stany Zjednoczone, 59711
- Community Hospital of Anaconda
-
Billings, Montana, Stany Zjednoczone, 59101
- Billings Clinic Cancer Center
-
Billings, Montana, Stany Zjednoczone, 59101
- Saint Vincent Healthcare
-
Billings, Montana, Stany Zjednoczone, 59102
- Saint Vincent Frontier Cancer Center
-
Bozeman, Montana, Stany Zjednoczone, 59715
- Bozeman Health Deaconess Hospital
-
Butte, Montana, Stany Zjednoczone, 59701
- Saint James Community Hospital and Cancer Treatment Center
-
Great Falls, Montana, Stany Zjednoczone, 59405
- Great Falls Clinic
-
Great Falls, Montana, Stany Zjednoczone, 59405
- Benefis Sletten Cancer Institute
-
Helena, Montana, Stany Zjednoczone, 59601
- Saint Peter's Community Hospital
-
Kalispell, Montana, Stany Zjednoczone, 59901
- Logan Health Medical Center
-
Missoula, Montana, Stany Zjednoczone, 59802
- Saint Patrick Hospital - Community Hospital
-
Missoula, Montana, Stany Zjednoczone, 59804
- Community Medical Center
-
-
Nebraska
-
Bellevue, Nebraska, Stany Zjednoczone, 68123
- Nebraska Medicine-Bellevue
-
Omaha, Nebraska, Stany Zjednoczone, 68198
- University of Nebraska Medical Center
-
Omaha, Nebraska, Stany Zjednoczone, 68118
- Nebraska Medicine-Village Pointe
-
-
Nevada
-
Carson City, Nevada, Stany Zjednoczone, 89703
- Carson Tahoe Regional Medical Center
-
Henderson, Nevada, Stany Zjednoczone, 89052
- Comprehensive Cancer Centers of Nevada - Henderson
-
Henderson, Nevada, Stany Zjednoczone, 89052
- Cancer and Blood Specialists-Henderson
-
Henderson, Nevada, Stany Zjednoczone, 89052
- Las Vegas Cancer Center-Henderson
-
Henderson, Nevada, Stany Zjednoczone, 89074
- Comprehensive Cancer Centers of Nevada-Southeast Henderson
-
Henderson, Nevada, Stany Zjednoczone, 89052
- Comprehensive Cancer Centers of Nevada-Horizon Ridge
-
Henderson, Nevada, Stany Zjednoczone, 89074
- Las Vegas Urology - Green Valley
-
Henderson, Nevada, Stany Zjednoczone, 89074
- Las Vegas Urology - Pebble
-
Henderson, Nevada, Stany Zjednoczone, 89074
- Urology Specialists of Nevada - Green Valley
-
Henderson, Nevada, Stany Zjednoczone, 89074
- Oncology Las Vegas - Henderson
-
Las Vegas, Nevada, Stany Zjednoczone, 89144
- Summerlin Hospital Medical Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89109
- Sunrise Hospital and Medical Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89102
- OptumCare Cancer Care at Charleston
-
Las Vegas, Nevada, Stany Zjednoczone, 89106
- Radiation Oncology Centers of Nevada Central
-
Las Vegas, Nevada, Stany Zjednoczone, 89119
- Radiation Oncology Centers of Nevada Southeast
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Comprehensive Cancer Centers of Nevada - Northwest
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- OptumCare Cancer Care at MountainView
-
Las Vegas, Nevada, Stany Zjednoczone, 89135
- Alliance for Childhood Diseases/Cure 4 the Kids Foundation
-
Las Vegas, Nevada, Stany Zjednoczone, 89144
- Comprehensive Cancer Centers of Nevada - Town Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89144
- Comprehensive Cancer Centers of Nevada-Summerlin
-
Las Vegas, Nevada, Stany Zjednoczone, 89148
- Comprehensive Cancer Centers of Nevada
-
Las Vegas, Nevada, Stany Zjednoczone, 89169
- Comprehensive Cancer Centers of Nevada - Central Valley
-
Las Vegas, Nevada, Stany Zjednoczone, 89102
- University Medical Center of Southern Nevada
-
Las Vegas, Nevada, Stany Zjednoczone, 89106
- Cancer and Blood Specialists-Shadow
-
Las Vegas, Nevada, Stany Zjednoczone, 89109
- HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
-
Las Vegas, Nevada, Stany Zjednoczone, 89113
- HealthCare Partners Medical Group Oncology/Hematology-San Martin
-
Las Vegas, Nevada, Stany Zjednoczone, 89121
- Cancer Therapy and Integrative Medicine
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Cancer and Blood Specialists-Tenaya
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- HealthCare Partners Medical Group Oncology/Hematology-Tenaya
-
Las Vegas, Nevada, Stany Zjednoczone, 89148-2405
- Las Vegas Cancer Center-Medical Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89149
- HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Ann M Wierman MD LTD
-
Las Vegas, Nevada, Stany Zjednoczone, 89074
- Las Vegas Urology - Pecos
-
Las Vegas, Nevada, Stany Zjednoczone, 89102
- Desert West Surgery
-
Las Vegas, Nevada, Stany Zjednoczone, 89103
- Hope Cancer Care of Nevada
-
Las Vegas, Nevada, Stany Zjednoczone, 89106
- Urology Specialists of Nevada - Central
-
Las Vegas, Nevada, Stany Zjednoczone, 89113
- Las Vegas Prostate Cancer Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89113
- Las Vegas Urology - Sunset
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Las Vegas Urology - Cathedral Rock
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Las Vegas Urology - Smoke Ranch
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Urology Specialists of Nevada - Northwest
-
Las Vegas, Nevada, Stany Zjednoczone, 89169
- University Cancer Center
-
Las Vegas, Nevada, Stany Zjednoczone, 89113
- Urology Specialists of Nevada - Southwest
-
Las Vegas, Nevada, Stany Zjednoczone, 89128
- Oncology Las Vegas - Tenaya
-
Las Vegas, Nevada, Stany Zjednoczone, 89183
- OptumCare Cancer Care at Fort Apache
-
Pahrump, Nevada, Stany Zjednoczone, 89048
- Hope Cancer Care of Nevada-Pahrump
-
Reno, Nevada, Stany Zjednoczone, 89502
- Renown Regional Medical Center
-
Reno, Nevada, Stany Zjednoczone, 89503
- Saint Mary's Regional Medical Center
-
Reno, Nevada, Stany Zjednoczone, 89509
- Radiation Oncology Associates
-
-
New Hampshire
-
Lebanon, New Hampshire, Stany Zjednoczone, 03756
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
-
-
New Jersey
-
Basking Ridge, New Jersey, Stany Zjednoczone, 07920
- Memorial Sloan Kettering Basking Ridge
-
Middletown, New Jersey, Stany Zjednoczone, 07748
- Memorial Sloan Kettering Monmouth
-
Montvale, New Jersey, Stany Zjednoczone, 07645
- Memorial Sloan Kettering Bergen
-
New Brunswick, New Jersey, Stany Zjednoczone, 08903
- Rutgers Cancer Institute of New Jersey
-
-
New York
-
Buffalo, New York, Stany Zjednoczone, 14263
- Roswell Park Cancer Institute
-
Commack, New York, Stany Zjednoczone, 11725
- Memorial Sloan Kettering Commack
-
Harrison, New York, Stany Zjednoczone, 10604
- Memorial Sloan Kettering Westchester
-
Lake Success, New York, Stany Zjednoczone, 11042
- Northwell Health/Center for Advanced Medicine
-
Manhasset, New York, Stany Zjednoczone, 11030
- North Shore University Hospital
-
New Hyde Park, New York, Stany Zjednoczone, 11040
- Long Island Jewish Medical Center
-
New York, New York, Stany Zjednoczone, 10065
- Memorial Sloan Kettering Cancer Center
-
Rochester, New York, Stany Zjednoczone, 14642
- University of Rochester
-
Stony Brook, New York, Stany Zjednoczone, 11794
- Stony Brook University Medical Center
-
The Bronx, New York, Stany Zjednoczone, 10461
- Montefiore Medical Center-Einstein Campus
-
The Bronx, New York, Stany Zjednoczone, 10467
- Montefiore Medical Center - Moses Campus
-
The Bronx, New York, Stany Zjednoczone, 10461
- Montefiore Medical Center-Weiler Hospital
-
Uniondale, New York, Stany Zjednoczone, 11553
- Memorial Sloan Kettering Nassau
-
-
North Carolina
-
Asheville, North Carolina, Stany Zjednoczone, 28803
- AdventHealth Infusion Center Asheville
-
Chapel Hill, North Carolina, Stany Zjednoczone, 27599
- UNC Lineberger Comprehensive Cancer Center
-
Clyde, North Carolina, Stany Zjednoczone, 28721
- AdventHealth Infusion Center Haywood
-
Hendersonville, North Carolina, Stany Zjednoczone, 28792
- AdventHealth Hendersonville
-
Winston-Salem, North Carolina, Stany Zjednoczone, 27157
- Wake Forest University Health Sciences
-
-
Ohio
-
Beavercreek, Ohio, Stany Zjednoczone, 45431
- Indu and Raj Soin Medical Center
-
Boardman, Ohio, Stany Zjednoczone, 44512
- Saint Elizabeth Boardman Hospital
-
Bowling Green, Ohio, Stany Zjednoczone, 43402
- Toledo Clinic Cancer Centers-Bowling Green
-
Centerville, Ohio, Stany Zjednoczone, 45459
- Miami Valley Hospital South
-
Centerville, Ohio, Stany Zjednoczone, 45459
- Dayton Physicians LLC-Miami Valley South
-
Cincinnati, Ohio, Stany Zjednoczone, 45219
- University of Cincinnati Cancer Center-UC Medical Center
-
Cincinnati, Ohio, Stany Zjednoczone, 45242
- Oncology Hematology Care Inc-Blue Ash
-
Cincinnati, Ohio, Stany Zjednoczone, 45202
- Oncology Hematology Care Inc-Eden Park
-
Cincinnati, Ohio, Stany Zjednoczone, 45211
- Oncology Hematology Care Inc-Mercy West
-
Cincinnati, Ohio, Stany Zjednoczone, 45230
- Oncology Hematology Care Inc-Anderson
-
Cincinnati, Ohio, Stany Zjednoczone, 45236
- Oncology Hematology Care Inc-Kenwood
-
Cleveland, Ohio, Stany Zjednoczone, 44106
- Case Western Reserve University
-
Cleveland, Ohio, Stany Zjednoczone, 44195
- Cleveland Clinic Foundation
-
Columbus, Ohio, Stany Zjednoczone, 43210
- Ohio State University Comprehensive Cancer Center
-
Dayton, Ohio, Stany Zjednoczone, 45406
- Good Samaritan Hospital - Dayton
-
Dayton, Ohio, Stany Zjednoczone, 45409
- Miami Valley Hospital
-
Dayton, Ohio, Stany Zjednoczone, 45415
- Miami Valley Hospital North
-
Dayton, Ohio, Stany Zjednoczone, 45415
- Dayton Physician LLC - Englewood
-
Fairfield, Ohio, Stany Zjednoczone, 45014
- Oncology Hematology Care Inc-Healthplex
-
Findlay, Ohio, Stany Zjednoczone, 45840
- Blanchard Valley Hospital
-
Findlay, Ohio, Stany Zjednoczone, 45840
- Armes Family Cancer Center
-
Findlay, Ohio, Stany Zjednoczone, 45840
- Orion Cancer Care
-
Franklin, Ohio, Stany Zjednoczone, 45005-1066
- Atrium Medical Center-Middletown Regional Hospital
-
Franklin, Ohio, Stany Zjednoczone, 45005
- Dayton Physicians LLC-Atrium
-
Greenville, Ohio, Stany Zjednoczone, 45331
- Wayne Hospital
-
Greenville, Ohio, Stany Zjednoczone, 45331
- Dayton Physicians LLC-Wayne
-
Kettering, Ohio, Stany Zjednoczone, 45429
- Kettering Medical Center
-
Kettering, Ohio, Stany Zjednoczone, 45409
- Greater Dayton Cancer Center
-
Kettering, Ohio, Stany Zjednoczone, 45420
- First Dayton Cancer Care
-
Lima, Ohio, Stany Zjednoczone, 45804
- Lima Memorial Hospital
-
Maumee, Ohio, Stany Zjednoczone, 43537
- Toledo Clinic Cancer Centers-Maumee
-
Maumee, Ohio, Stany Zjednoczone, 43537
- Toledo Radiation Oncology at Northwest Ohio Onocolgy Center
-
Middletown, Ohio, Stany Zjednoczone, 45042
- Dayton Physicians LLC-Signal Point
-
Oregon, Ohio, Stany Zjednoczone, 43616
- Saint Charles Hospital
-
Oregon, Ohio, Stany Zjednoczone, 43616
- Toledo Clinic Cancer Centers-Oregon
-
Sidney, Ohio, Stany Zjednoczone, 45365
- Dayton Physicians LLC-Wilson
-
Springfield, Ohio, Stany Zjednoczone, 45504
- Springfield Regional Cancer Center
-
Springfield, Ohio, Stany Zjednoczone, 45504
- Springfield Regional Medical Center
-
Sylvania, Ohio, Stany Zjednoczone, 43560
- ProMedica Flower Hospital
-
Tiffin, Ohio, Stany Zjednoczone, 44883
- Mercy Hospital of Tiffin
-
Toledo, Ohio, Stany Zjednoczone, 43606
- ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
-
Toledo, Ohio, Stany Zjednoczone, 43623
- Mercy Health - Saint Anne Hospital
-
Toledo, Ohio, Stany Zjednoczone, 43623
- Toledo Clinic Cancer Centers-Toledo
-
Toledo, Ohio, Stany Zjednoczone, 43614
- University of Toledo
-
Toledo, Ohio, Stany Zjednoczone, 43617
- Toledo Community Hospital Oncology Program CCOP
-
Toledo, Ohio, Stany Zjednoczone, 43608
- Mercy Health - Saint Vincent Hospital
-
Troy, Ohio, Stany Zjednoczone, 45373
- Upper Valley Medical Center
-
Troy, Ohio, Stany Zjednoczone, 45373
- Dayton Physicians LLC - Troy
-
Warren, Ohio, Stany Zjednoczone, 44484
- Saint Joseph Warren Hospital
-
Wauseon, Ohio, Stany Zjednoczone, 43567
- Fulton County Health Center
-
West Chester, Ohio, Stany Zjednoczone, 45069
- University of Cincinnati Cancer Center-West Chester
-
Wright-Patterson Air Force Base, Ohio, Stany Zjednoczone, 45433
- Wright-Patterson Medical Center
-
Youngstown, Ohio, Stany Zjednoczone, 44501
- Saint Elizabeth Youngstown Hospital
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 73104
- University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Stany Zjednoczone, 73120
- Mercy Hospital Oklahoma City
-
-
Oregon
-
Baker City, Oregon, Stany Zjednoczone, 97814
- Saint Alphonsus Cancer Care Center-Baker City
-
Bend, Oregon, Stany Zjednoczone, 97701
- Saint Charles Health System
-
Clackamas, Oregon, Stany Zjednoczone, 97015
- Clackamas Radiation Oncology Center
-
Clackamas, Oregon, Stany Zjednoczone, 97015
- Providence Cancer Institute Clackamas Clinic
-
Coos Bay, Oregon, Stany Zjednoczone, 97420
- Bay Area Hospital
-
Newberg, Oregon, Stany Zjednoczone, 97132
- Providence Newberg Medical Center
-
Ontario, Oregon, Stany Zjednoczone, 97914
- Saint Alphonsus Cancer Care Center-Ontario
-
Oregon City, Oregon, Stany Zjednoczone, 97045
- Providence Willamette Falls Medical Center
-
Portland, Oregon, Stany Zjednoczone, 97213
- Providence Portland Medical Center
-
Portland, Oregon, Stany Zjednoczone, 97225
- Providence Saint Vincent Medical Center
-
Redmond, Oregon, Stany Zjednoczone, 97756
- Saint Charles Health System-Redmond
-
-
Pennsylvania
-
Danville, Pennsylvania, Stany Zjednoczone, 17822
- Geisinger Medical Center
-
Hershey, Pennsylvania, Stany Zjednoczone, 17033-0850
- Penn State Milton S Hershey Medical Center
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19111
- Fox Chase Cancer Center
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19107
- Thomas Jefferson University Hospital
-
Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- University of Pennsylvania/Abramson Cancer Center
-
Pittsburgh, Pennsylvania, Stany Zjednoczone, 15232
- UPMC Hillman Cancer Center
-
Scranton, Pennsylvania, Stany Zjednoczone, 18510
- Community Medical Center
-
-
South Carolina
-
Anderson, South Carolina, Stany Zjednoczone, 29621
- AnMed Health Cancer Center
-
Boiling Springs, South Carolina, Stany Zjednoczone, 29316
- Prisma Health Cancer Institute - Spartanburg
-
Easley, South Carolina, Stany Zjednoczone, 29640
- Prisma Health Cancer Institute - Easley
-
Gaffney, South Carolina, Stany Zjednoczone, 29341
- Gibbs Cancer Center-Gaffney
-
Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Cancer Institute - Faris
-
Greenville, South Carolina, Stany Zjednoczone, 29607
- Saint Francis Cancer Center
-
Greenville, South Carolina, Stany Zjednoczone, 29615
- Prisma Health Cancer Institute - Eastside
-
Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Cancer Institute - Butternut
-
Greenville, South Carolina, Stany Zjednoczone, 29601
- Saint Francis Hospital
-
Greenville, South Carolina, Stany Zjednoczone, 29605
- Prisma Health Greenville Memorial Hospital
-
Greenville, South Carolina, Stany Zjednoczone, 29601
- Greenville Health System Cancer Institute-Andrews
-
Greer, South Carolina, Stany Zjednoczone, 29650
- Prisma Health Cancer Institute - Greer
-
Greer, South Carolina, Stany Zjednoczone, 29651
- Gibbs Cancer Center-Pelham
-
Lancaster, South Carolina, Stany Zjednoczone, 29720
- Carolina Blood and Cancer Care Associates PA-Lancaster
-
Rock Hill, South Carolina, Stany Zjednoczone, 29732
- Carolina Blood and Cancer Care Associates PA
-
Seneca, South Carolina, Stany Zjednoczone, 29672
- Prisma Health Cancer Institute - Seneca
-
Spartanburg, South Carolina, Stany Zjednoczone, 29303
- Spartanburg Medical Center
-
-
Tennessee
-
Franklin, Tennessee, Stany Zjednoczone, 37067
- Vanderbilt-Ingram Cancer Center Cool Springs
-
Nashville, Tennessee, Stany Zjednoczone, 37232
- Vanderbilt University/Ingram Cancer Center
-
Nashville, Tennessee, Stany Zjednoczone, 37204
- Vanderbilt Breast Center at One Hundred Oaks
-
-
Texas
-
Dallas, Texas, Stany Zjednoczone, 75235
- Parkland Memorial Hospital
-
Dallas, Texas, Stany Zjednoczone, 75390
- UT Southwestern/Simmons Cancer Center-Dallas
-
Houston, Texas, Stany Zjednoczone, 77030
- Houston Methodist Hospital
-
Houston, Texas, Stany Zjednoczone, 77030
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
-
Houston, Texas, Stany Zjednoczone, 77030
- Ben Taub General Hospital
-
-
Utah
-
American Fork, Utah, Stany Zjednoczone, 84003
- American Fork Hospital / Huntsman Intermountain Cancer Center
-
Cedar City, Utah, Stany Zjednoczone, 84720
- Sandra L Maxwell Cancer Center
-
Farmington, Utah, Stany Zjednoczone, 84025
- Farmington Health Center
-
Logan, Utah, Stany Zjednoczone, 84321
- Logan Regional Hospital
-
Murray, Utah, Stany Zjednoczone, 84107
- Intermountain Medical Center
-
Ogden, Utah, Stany Zjednoczone, 84403
- McKay-Dee Hospital Center
-
Provo, Utah, Stany Zjednoczone, 84604
- Utah Valley Regional Medical Center
-
Riverton, Utah, Stany Zjednoczone, 84065
- Riverton Hospital
-
Salt Lake City, Utah, Stany Zjednoczone, 84112
- Huntsman Cancer Institute/University of Utah
-
Salt Lake City, Utah, Stany Zjednoczone, 84106
- Utah Cancer Specialists-Salt Lake City
-
Salt Lake City, Utah, Stany Zjednoczone, 84143
- LDS Hospital
-
South Jordan, Utah, Stany Zjednoczone, 84009
- South Jordan Health Center
-
St. George, Utah, Stany Zjednoczone, 84770
- Saint George Regional Medical Center
-
-
Virginia
-
Fredericksburg, Virginia, Stany Zjednoczone, 22401
- Fredericksburg Oncology Inc
-
Richmond, Virginia, Stany Zjednoczone, 23235
- VCU Massey Cancer Center at Stony Point
-
Richmond, Virginia, Stany Zjednoczone, 23298
- VCU Massey Comprehensive Cancer Center
-
-
Washington
-
Aberdeen, Washington, Stany Zjednoczone, 98520
- Providence Regional Cancer System-Aberdeen
-
Anacortes, Washington, Stany Zjednoczone, 98221
- Cancer Care Center at Island Hospital
-
Auburn, Washington, Stany Zjednoczone, 98001
- MultiCare Auburn Medical Center
-
Bellevue, Washington, Stany Zjednoczone, 98004
- Overlake Medical Center
-
Bellevue, Washington, Stany Zjednoczone, 98005
- Swedish Cancer Institute-Eastside Oncology Hematology
-
Bellingham, Washington, Stany Zjednoczone, 98225
- PeaceHealth Saint Joseph Medical Center
-
Centralia, Washington, Stany Zjednoczone, 98531
- Providence Regional Cancer System-Centralia
-
Edmonds, Washington, Stany Zjednoczone, 98026
- Swedish Cancer Institute-Edmonds
-
Everett, Washington, Stany Zjednoczone, 98201
- Providence Regional Cancer Partnership
-
Gig Harbor, Washington, Stany Zjednoczone, 98335
- MultiCare Gig Harbor Medical Park
-
Issaquah, Washington, Stany Zjednoczone, 98029
- Swedish Cancer Institute-Issaquah
-
Kennewick, Washington, Stany Zjednoczone, 99336
- Kadlec Clinic Hematology and Oncology
-
Lacey, Washington, Stany Zjednoczone, 98503
- Providence Regional Cancer System-Lacey
-
Longview, Washington, Stany Zjednoczone, 98632
- PeaceHealth Saint John Medical Center
-
Port Townsend, Washington, Stany Zjednoczone, 98368
- Jefferson Healthcare
-
Puyallup, Washington, Stany Zjednoczone, 98372
- MultiCare Good Samaritan Hospital
-
Renton, Washington, Stany Zjednoczone, 98055
- Valley Medical Center
-
Seattle, Washington, Stany Zjednoczone, 98107
- Swedish Medical Center-Ballard Campus
-
Seattle, Washington, Stany Zjednoczone, 98122
- Swedish Medical Center-First Hill
-
Seattle, Washington, Stany Zjednoczone, 98112
- Kaiser Permanente Washington
-
Seattle, Washington, Stany Zjednoczone, 98104
- Minor and James Medical PLLC
-
Seattle, Washington, Stany Zjednoczone, 98104
- Pacific Gynecology Specialists
-
Seattle, Washington, Stany Zjednoczone, 98122-5711
- Swedish Medical Center-Cherry Hill
-
Sedro-Woolley, Washington, Stany Zjednoczone, 98284
- PeaceHealth United General Medical Center
-
Shelton, Washington, Stany Zjednoczone, 98584
- Providence Regional Cancer System-Shelton
-
Spokane, Washington, Stany Zjednoczone, 99218
- Evergreen Hematology and Oncology PS
-
Spokane, Washington, Stany Zjednoczone, 99204
- MultiCare Deaconess Cancer and Blood Specialty Center - Downtown
-
Spokane, Washington, Stany Zjednoczone, 99218
- MultiCare Deaconess Cancer and Blood Specialty Center - North
-
Spokane Valley, Washington, Stany Zjednoczone, 99216
- MultiCare Deaconess Cancer and Blood Specialty Center - Valley
-
Tacoma, Washington, Stany Zjednoczone, 98405
- Mary Bridge Children's Hospital and Health Center
-
Tacoma, Washington, Stany Zjednoczone, 98405
- MultiCare Tacoma General Hospital
-
Vancouver, Washington, Stany Zjednoczone, 98664
- PeaceHealth Southwest Medical Center
-
Walla Walla, Washington, Stany Zjednoczone, 99362
- Providence Saint Mary Regional Cancer Center
-
Yakima, Washington, Stany Zjednoczone, 98902
- North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
-
Yelm, Washington, Stany Zjednoczone, 98597
- Providence Regional Cancer System-Yelm
-
-
Wisconsin
-
Eau Claire, Wisconsin, Stany Zjednoczone, 54701
- Marshfield Medical Center-EC Cancer Center
-
Eau Claire, Wisconsin, Stany Zjednoczone, 54701
- Marshfield Clinic Cancer Center at Sacred Heart
-
Green Bay, Wisconsin, Stany Zjednoczone, 54301
- Saint Vincent Hospital Cancer Center Green Bay
-
Green Bay, Wisconsin, Stany Zjednoczone, 54303
- Saint Vincent Hospital Cancer Center at Saint Mary's
-
La Crosse, Wisconsin, Stany Zjednoczone, 54601
- Gundersen Lutheran Medical Center
-
Madison, Wisconsin, Stany Zjednoczone, 53792
- University of Wisconsin Carbone Cancer Center - University Hospital
-
Manitowoc, Wisconsin, Stany Zjednoczone, 54221
- Holy Family Memorial Hospital
-
Marinette, Wisconsin, Stany Zjednoczone, 54143
- Saint Vincent Hospital Cancer Center at Marinette
-
Marshfield, Wisconsin, Stany Zjednoczone, 54449
- Marshfield Medical Center-Marshfield
-
Marshfield, Wisconsin, Stany Zjednoczone, 54449
- Marshfield Medical Center
-
Milwaukee, Wisconsin, Stany Zjednoczone, 53226
- Medical College of Wisconsin
-
Minocqua, Wisconsin, Stany Zjednoczone, 54548
- Marshfield Medical Center - Minocqua
-
Oconto Falls, Wisconsin, Stany Zjednoczone, 54154
- Saint Vincent Hospital Cancer Center at Oconto Falls
-
Rice Lake, Wisconsin, Stany Zjednoczone, 54868
- Marshfield Medical Center-Rice Lake
-
Sheboygan, Wisconsin, Stany Zjednoczone, 53081
- HSHS Saint Nicholas Hospital
-
Stevens Point, Wisconsin, Stany Zjednoczone, 54482
- Marshfield Medical Center-River Region at Stevens Point
-
Sturgeon Bay, Wisconsin, Stany Zjednoczone, 54235-1495
- Saint Vincent Hospital Cancer Center at Sturgeon Bay
-
Wausau, Wisconsin, Stany Zjednoczone, 54401
- Marshfield Clinic-Wausau Center
-
Weston, Wisconsin, Stany Zjednoczone, 54476
- Marshfield Medical Center - Weston
-
-
Wyoming
-
Casper, Wyoming, Stany Zjednoczone, 82609
- Rocky Mountain Oncology
-
Cheyenne, Wyoming, Stany Zjednoczone, 82001
- Cheyenne Regional Medical Center-West
-
Cody, Wyoming, Stany Zjednoczone, 82414
- Big Horn Basin Cancer Center
-
Cody, Wyoming, Stany Zjednoczone, 82414
- Billings Clinic-Cody
-
Sheridan, Wyoming, Stany Zjednoczone, 82801
- Welch Cancer Center
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
|---|---|
|
Eksperymentalny: Arm I (blinatumomab, chemotherapy)
See Detailed Description |
Given IV
Inne nazwy:
Given PO
Inne nazwy:
Undergo bone marrow biopsy
Inne nazwy:
Undergo blood sample collection
Inne nazwy:
Given IV
Inne nazwy:
Given IV
Inne nazwy:
Given IV
Inne nazwy:
Given PO
Inne nazwy:
Undergo allogeneic hematopoietic SCT
Inne nazwy:
Given IV
Inne nazwy:
Undergo bone marrow aspiration Given IT, IV, or SC
Inne nazwy:
Given IV
Inne nazwy:
Given IV
Inne nazwy:
Given IV
Inne nazwy:
Given IV or PO
Inne nazwy:
Undergo lumbar puncture
Inne nazwy:
Given PO
Inne nazwy:
Given PO, IT or IV
Inne nazwy:
Given IM or IV
Inne nazwy:
Undergo x-ray imaging
Inne nazwy:
|
|
Aktywny komparator: Arm II (chemotherapy)
See Detailed Description |
Given IV
Inne nazwy:
Given PO
Inne nazwy:
Undergo bone marrow biopsy
Inne nazwy:
Undergo blood sample collection
Inne nazwy:
Given IV
Inne nazwy:
Given IV
Inne nazwy:
Given IV
Inne nazwy:
Given PO
Inne nazwy:
Undergo allogeneic hematopoietic SCT
Inne nazwy:
Undergo bone marrow aspiration Given IT, IV, or SC
Inne nazwy:
Given IV
Inne nazwy:
Given IV
Inne nazwy:
Given IV
Inne nazwy:
Given IV or PO
Inne nazwy:
Undergo lumbar puncture
Inne nazwy:
Given PO
Inne nazwy:
Given PO, IT or IV
Inne nazwy:
Given IM or IV
Inne nazwy:
Undergo x-ray imaging
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Overall Survival (OS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Relapse-free Survival (RFS) Among Patients Who Were MRD Negative After Induction and Intensification Chemotherapy
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Inne miary wyników
Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
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
Ramy czasowe: 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
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Incidence of Anti-blinatumomab Antibody Formation
Ramy czasowe: Assessed at baseline, end of 2 cycles of blinatumomab, end of 4 cycles of blinatumomab, and end of blinatumomab treatment
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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
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Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Główny śledczy: Mark R Litzow, ECOG-ACRIN Cancer Research Group
Publikacje i pomocne linki
Publikacje ogólne
- 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.
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Szacowany)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
- Nowotwory
- Choroby układu odpornościowego
- Infekcje
- Choroby wirusowe
- Nowotwory według typu histologicznego
- Choroby hematologiczne
- Infekcje wirusami DNA
- Choroby limfatyczne
- Zaburzenia limfoproliferacyjne
- Zaburzenia immunoproliferacyjne
- Chłoniak nieziarniczy
- Chłoniak z komórek B
- Chłoniak
- Białaczka, układ limfatyczny
- Białaczka
- Zakażenia wirusem Epsteina-Barra
- Infekcje Herpesviridae
- Zakażenia wirusem nowotworowym
- Choroby hemowe i limfatyczne
- Prekursorowa komórkowa białaczka limfoblastyczna-chłoniak
- Chłoniak Burkitta
- Aminokwasy, peptydy i białka
- Białka
- Związki siarki
- Organiczne chemikalia
- Związki heterocykliczne, 1-ring
- Związki heterocykliczne
- Związki heterocykliczne, 2-ring
- Związki heterocykliczne, sterowanie stopieniem
- Techniki śledcze
- Lecznictwo
- Techniki laboratoryjne kliniczne
- Techniki i procedury diagnostyczne
- Diagnoza
- Nakłucia
- Procedury chirurgiczne, operacyjny
- Techniki cytologiczne
- Kwasy nukleinowe, nukleotydy i nukleozydy
- Cytodiagnoza
- Węglowodory
- Węglowodory, cykliczne
- Węglowodany
- Zjawiska fizyczne
- Alkaloidy
- Podofilotoksyna
- Tetrahydronafthalenes
- Naftaleny
- Policykliczne aromatyczne węglowodory
- Węglowodory, aromatyczne
- Związki policykliczne
- Glukozydy
- Glikozydy
- Przeszczep
- Sprzęt i materiały eksploatacyjne
- Enzymy i koenzymy
- Indole
- Przeciwciała, monoklonalne
- Przeciwciała
- Immunoglobuliny
- Immunoproteiny
- Białka krwi
- Globuliny w surowicy
- Globuliny
- Puryny
- Cytydyna
- Nukleozydy pirymidynowe
- Pirymidyn
- Ciąży
- Ciężarne
- Steroidy
- Związki sterownika
- Sterydy, fluorowane
- Pochodne benzenu
- Techniki diagnostyczne, chirurgiczne
- Kwasy sulfonowe
- Kwasy siarkowe
- Mostki fosforamidu
- Związki musztardy azotu
- Związki musztardy
- Węglowodory, uboczne
- Fosforamidy
- Związki okorosfosforowe
- Nukleozydy
- FormylTetrahydrofolates
- Tetrahydrofolety
- Kwas foliowy
- Pterins
- Perydyny
- Ciąży
- Ciąży
- Vinca alkaloidy
- Sesologanina alkaloidy tryptaminy
- Alkaloidy indole
- Indolizicyny
- Indolizyny
- Arabinonukleozydy
- Aminopterina
- Antracykliny
- Naftaceny
- Aminoglikozydy
- Koenzymy
- Zjawiska elektromagnetyczne
- Zjawiska magnetyczne
- Przeciwciała, monoklonalne, mysie
- Przeszczep komórki
- Terapia oparta na komórkach i tkankach
- Terapia biologiczna
- Techniki diagnostyczne, neurologiczne
- Promieniowanie elektromagnetyczne
- Promieniowanie
- Promieniowanie, jonizujące
- Benzenezulfoniany
- Arylosulfoniany
- Kwasy arylosulfonowe
- Związki sulfhydrylowe
- Rytuksymab
- Deksametazon
- Metotreksat
- Prednizon
- Cyklofosfamid
- Cytarabina
- Etopozyd
- Leukoworyna
- Winkrystyna
- Daunorubicyna
- Merkaptopuryna
- Dobesylan wapnia
- Biopsja
- Prowadzenie okazów
- Blinatumomab
- Przeszczep komórek macierzystych
- Kłucie kręgosłupa
- 21-fosforan deksametazonu
- Promieniowanie rentgenowskie
- CT-P10
- Deltacortene
- prednielidene
- N, N-dicykloheksylo-izoborneol-10-sulfonamid
- azathiopuryna
- Merphos
- Pegaspargaza
- Phantoms, obrazowanie
- Auricularum
- octan deksametazonu
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- NCI-2013-02229
- U10CA180820 (Grant/umowa NIH USA)
- U24CA196172 (Grant/umowa NIH USA)
- U10CA021115 (Grant/umowa NIH USA)
- NCI-2013-02229 (Identyfikator rejestru: CTRP (Clinical Trial Reporting Program))
- ECOG-E1910
- E1910 (Inny identyfikator: CTEP)
- PE1910_A08PAMDREVW01
- E1910 (Inny identyfikator: ECOG-ACRIN Cancer Research Group)
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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