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Trattamento Venetoclax e HMA di adulti anziani e non idonei affetti da leucemia mieloide acuta (LMA) con mutazione FLT3 (uno studio di trattamento MyeloMATCH)

3 novembre 2026 aggiornato da: National Cancer Institute (NCI)

Uno studio randomizzato di fase II sulle terapie basate su Venetoclax e HMA per il trattamento di adulti anziani e non idonei affetti da leucemia mieloide acuta (LMA) con mutazione FLT3 di nuova diagnosi: uno studio di trattamento MyeloMATCH

This phase II MyeloMATCH treatment trial compares the usual treatment of azacitidine and venetoclax to the combination treatment of azacitidine, venetoclax and gilteritinib in treating older and unfit patients with acute myeloid leukemia and FLT3 mutations. Azacitidine is a drug that is absorbed into DNA and leads to the activation of cancer suppressor genes, which are genes that help control cell growth. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply. This study may help doctors find out if these different approaches are better than the usual approaches. To decide if they are better, the study doctors are looking to see if the study drugs lead to a higher percentage of patients achieving a deeper remission compared to the usual approach.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

PRIMARY OBJECTIVE:

I. To compare the achievement rate of measured residual disease negative (MRDneg) complete remission (CR) of either triplet regimen to azacitidine and venetoclax alone within 4 cycles of therapy.

SECONDARY OBJECTIVES:

I. To compare the achievement rate of MRDneg CR/complete remission with incomplete count recovery (CRi)/complete remission with partial hematologic recovery (CRh) of either triplet regimen to azacitidine and venetoclax alone within 4 cycles of therapy.

II. To determine the safety and tolerability of the combination of gilteritinib, azacitidine, and venetoclax, if both of the triplet regimens show superiority to the azacitidine plus venetoclax regimen.

III. To determine the optimal sequence and duration of gilteritinib, when added to azacitidine and venetoclax if both of the triplet regimens show superiority to the azacitidine plus venetoclax regimen.

IV. To estimate the rates of complete remission (CR), complete remission with incomplete count recovery (CRi), and complete remission with partial hematologic recovery (CRh), morphologic leukemia-free state (MLFS), event-free survival (EFS), and overall survival (OS) of the combination of gilteritinib, azacitidine, and venetoclax versus azacitidine and venetoclax alone.

EXPLORATORY OBJECTIVES:

I. To establish the degree of reduction in FLT3- internal tandem duplication (ITD) mutation burden after 2 and 4 cycles of therapy using a highly sensitive next-generation sequencing (NGS) MRD assay and compare the median reduction in the investigational regimens among patients with CR/CRi/CRh to that of control regimen.

II. To determine if the degree of FLT3 ITD reduction is associated with the duration of remission.

III. To monitor which leukemia-associated mutations are present at the time of relapse.

IV. To monitor which co-mutations at presentation are associated with lack of response to these regimens.

V. To determine if the FLT3 variant allele frequency (VAF) at study enrollment is associated with response to the regimens.

OUTLINE: Patients are randomized to 1 of 3 regimens.

REGIMEN 1:

INDUCTION: Patients receive azacitidine intravenously (IV) or subcutaneously (SC) on days 1-7 of each cycle and venetoclax orally (PO) on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

REGIMEN 2:

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

REGIMEN 3:

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

All patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.

After completion of study treatment, patients are followed up every 3 months if patient is < 2 years from randomization, every 6 months if patient is 2-5 years from randomization, and every year if patient is 5-10 years from randomization. All patients, including those who discontinue protocol therapy early, are followed for response until progression, even if non-protocol therapy is initiated, and for survival for 10 years from the date of randomization.

Tipo di studio

Interventistico

Iscrizione (Stimato)

147

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Reclutamento
        • Jewish General Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 8248 514-340-8222
        • Investigatore principale:
          • Sarit E. Assouline
  • Porto Rico
      • San Juan, Porto Rico, 00927
        • Reclutamento
        • Centro Comprensivo de Cancer de UPR
        • Investigatore principale:
          • Luis J. Santos Reyes
        • Contatto:
      • San Juan, Porto Rico, 00936
        • Reclutamento
        • San Juan City Hospital
        • Investigatore principale:
          • Luis J. Santos Reyes
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 787-763-1296
  • Stati Uniti
    • Alabama
      • Birmingham, Alabama, Stati Uniti, 35233
        • Reclutamento
        • University of Alabama at Birmingham Cancer Center
        • Investigatore principale:
          • Razan Mohty
        • Contatto:
    • Arizona
      • Tucson, Arizona, Stati Uniti, 85719
        • Reclutamento
        • Banner University Medical Center - Tucson
        • Investigatore principale:
          • Sharad Khurana
        • Contatto:
      • Tucson, Arizona, Stati Uniti, 85719
        • Reclutamento
        • University of Arizona Cancer Center-North Campus
        • Investigatore principale:
          • Sharad Khurana
        • Contatto:
    • Arkansas
      • Little Rock, Arkansas, Stati Uniti, 72205
        • Reclutamento
        • University of Arkansas for Medical Sciences
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 501-686-8274
        • Investigatore principale:
          • Ankur Varma
    • California
      • Berkeley, California, Stati Uniti, 94704
        • Attivo, non reclutante
        • Alta Bates Summit Medical Center-Herrick Campus
      • Dublin, California, Stati Uniti, 94568
        • Reclutamento
        • Kaiser Permanente Dublin
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
        • Investigatore principale:
          • Faisal N. Cheema
      • Fremont, California, Stati Uniti, 94538
        • Reclutamento
        • Kaiser Permanente-Fremont
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Fresno, California, Stati Uniti, 93720
        • Sospeso
        • Kaiser Permanente-Fresno
      • Fresno, California, Stati Uniti, 93720
        • Reclutamento
        • Kaiser Permanente Fresno Orchard Plaza
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 833-574-2273
        • Investigatore principale:
          • Faisal N. Cheema
      • Los Angeles, California, Stati Uniti, 90048
        • Reclutamento
        • Cedars-Sinai Medical Center
        • Investigatore principale:
          • Noah M. Merin
        • Contatto:
      • Modesto, California, Stati Uniti, 95356
        • Sospeso
        • Kaiser Permanente-Modesto
      • Modesto, California, Stati Uniti, 95356
        • Reclutamento
        • Kaiser Permanente- Modesto MOB II
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
        • Investigatore principale:
          • Faisal N. Cheema
      • Oakland, California, Stati Uniti, 94611
        • Reclutamento
        • Kaiser Permanente-Oakland
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Roseville, California, Stati Uniti, 95661
        • Reclutamento
        • Kaiser Permanente-Roseville
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Sacramento, California, Stati Uniti, 95817
        • Reclutamento
        • University of California Davis Comprehensive Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 916-734-3089
        • Investigatore principale:
          • Brian A. Jonas
      • Sacramento, California, Stati Uniti, 95814
        • Reclutamento
        • Kaiser Permanente Downtown Commons
        • Investigatore principale:
          • Faisal N. Cheema
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: kpoct@kp.org
      • Sacramento, California, Stati Uniti, 95823
        • Reclutamento
        • Kaiser Permanente-South Sacramento
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • San Francisco, California, Stati Uniti, 94115
        • Reclutamento
        • Kaiser Permanente-San Francisco
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • San Francisco, California, Stati Uniti, 94143
        • Reclutamento
        • UCSF Medical Center-Parnassus
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-827-3222
        • Investigatore principale:
          • Timothy Ferng
      • San Jose, California, Stati Uniti, 95119
        • Reclutamento
        • Kaiser Permanente-Santa Teresa-San Jose
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • San Leandro, California, Stati Uniti, 94577
        • Reclutamento
        • Kaiser Permanente San Leandro
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • San Mateo, California, Stati Uniti, 94401
        • Attivo, non reclutante
        • Mills Health Center
      • San Rafael, California, Stati Uniti, 94903
        • Reclutamento
        • Kaiser San Rafael-Gallinas
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Santa Clara, California, Stati Uniti, 95051
        • Reclutamento
        • Kaiser Permanente Medical Center - Santa Clara
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Santa Rosa, California, Stati Uniti, 95403
        • Reclutamento
        • Kaiser Permanente-Santa Rosa
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • South San Francisco, California, Stati Uniti, 94080
        • Reclutamento
        • Kaiser Permanente-South San Francisco
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Vallejo, California, Stati Uniti, 94589
        • Reclutamento
        • Kaiser Permanente-Vallejo
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
      • Walnut Creek, California, Stati Uniti, 94596
        • Reclutamento
        • Kaiser Permanente-Walnut Creek
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-642-4691
          • Email: Kpoct@kp.org
        • Investigatore principale:
          • Faisal N. Cheema
    • Connecticut
      • New Haven, Connecticut, Stati Uniti, 06520
        • Reclutamento
        • Yale University
        • Contatto:
        • Investigatore principale:
          • Jan P. Bewersdorf
      • West Haven, Connecticut, Stati Uniti, 06516
        • Reclutamento
        • Veterans Affairs Connecticut Healthcare System-West Haven Campus
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 2832 203-937-3421
        • Investigatore principale:
          • Alexander Pine
    • Florida
      • Gainesville, Florida, Stati Uniti, 32610
        • Reclutamento
        • UF Health Cancer Institute - Gainesville
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 352-273-8010
        • Investigatore principale:
          • Dina G. Khalaf
      • Miami, Florida, Stati Uniti, 33176
        • Reclutamento
        • Miami Cancer Institute
        • Investigatore principale:
          • Firas El Chaer
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 786-596-2000
    • Georgia
      • Albany, Georgia, Stati Uniti, 31701
        • Reclutamento
        • Phoebe Putney Memorial Hospital
        • Investigatore principale:
          • Vamsi Kota
        • Contatto:
      • Augusta, Georgia, Stati Uniti, 30912
        • Sospeso
        • Augusta University Medical Center
    • Hawaii
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Reclutamento
        • Hawaii Cancer Care Inc - Waterfront Plaza
        • Investigatore principale:
          • Craig S. Boddy
        • Contatto:
      • Honolulu, Hawaii, Stati Uniti, 96813
        • Reclutamento
        • Straub Clinic and Hospital
        • Investigatore principale:
          • Craig S. Boddy
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 808-522-4333
      • Honolulu, Hawaii, Stati Uniti, 96819
        • Reclutamento
        • Kaiser Permanente Moanalua Medical Center
        • Contatto:
        • Investigatore principale:
          • Faisal N. Cheema
      • ‘Aiea, Hawaii, Stati Uniti, 96701
        • Reclutamento
        • Hawaii Cancer Care - Westridge
        • Investigatore principale:
          • Craig S. Boddy
        • Contatto:
      • ‘Aiea, Hawaii, Stati Uniti, 96701
        • Reclutamento
        • Pali Momi Medical Center
        • Investigatore principale:
          • Craig S. Boddy
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 808-486-6000
    • Idaho
      • Boise, Idaho, Stati Uniti, 83712
        • Reclutamento
        • Saint Luke's Cancer Institute - Boise
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Boise, Idaho, Stati Uniti, 83706
        • Reclutamento
        • Saint Alphonsus Cancer Care Center-Boise
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Caldwell, Idaho, Stati Uniti, 83605
        • Reclutamento
        • Saint Alphonsus Cancer Care Center-Caldwell
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Coeur d'Alene, Idaho, Stati Uniti, 83814
        • Reclutamento
        • Kootenai Health - Coeur d'Alene
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Fruitland, Idaho, Stati Uniti, 83619
        • Reclutamento
        • Saint Luke's Cancer Institute - Fruitland
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Meridian, Idaho, Stati Uniti, 83642
        • Reclutamento
        • Saint Luke's Cancer Institute - Meridian
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Nampa, Idaho, Stati Uniti, 83687
        • Reclutamento
        • Saint Luke's Cancer Institute - Nampa
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Nampa, Idaho, Stati Uniti, 83687
        • Reclutamento
        • Saint Alphonsus Cancer Care Center-Nampa
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Post Falls, Idaho, Stati Uniti, 83854
        • Reclutamento
        • Kootenai Clinic Cancer Services - Post Falls
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Sandpoint, Idaho, Stati Uniti, 83864
        • Reclutamento
        • Kootenai Clinic Cancer Services - Sandpoint
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60637
        • Reclutamento
        • University of Chicago Comprehensive Cancer Center
        • Contatto:
        • Investigatore principale:
          • Olatoyosi M. Odenike
      • Chicago, Illinois, Stati Uniti, 60611
        • Reclutamento
        • Northwestern University
        • Contatto:
        • Investigatore principale:
          • Yasmin Abaza
      • Chicago, Illinois, Stati Uniti, 60612
        • Reclutamento
        • University of Illinois
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 312-355-3046
        • Investigatore principale:
          • Noah Birch
      • Danville, Illinois, Stati Uniti, 61832
        • Reclutamento
        • Carle at The Riverfront
        • Investigatore principale:
          • Suparna Mantha
        • Contatto:
      • DeKalb, Illinois, Stati Uniti, 60115
        • Reclutamento
        • Northwestern Medicine Cancer Center Kishwaukee
        • Contatto:
        • Investigatore principale:
          • Yasmin Abaza
      • Decatur, Illinois, Stati Uniti, 62526
        • Reclutamento
        • Cancer Care Specialists of Illinois - Decatur
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Decatur, Illinois, Stati Uniti, 62526
        • Reclutamento
        • Decatur Memorial Hospital
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Effingham, Illinois, Stati Uniti, 62401
        • Reclutamento
        • Carle Physician Group-Effingham
        • Investigatore principale:
          • Suparna Mantha
        • Contatto:
      • Effingham, Illinois, Stati Uniti, 62401
        • Reclutamento
        • Crossroads Cancer Center
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Evanston, Illinois, Stati Uniti, 60201
        • Reclutamento
        • NorthShore University HealthSystem-Evanston Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 847-570-2109
        • Investigatore principale:
          • Robert M. Eisner
      • Geneva, Illinois, Stati Uniti, 60134
        • Reclutamento
        • Northwestern Medicine Cancer Center Delnor
        • Contatto:
        • Investigatore principale:
          • Yasmin Abaza
      • Glenview, Illinois, Stati Uniti, 60026
        • Reclutamento
        • NorthShore University HealthSystem-Glenbrook Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 847-570-2109
        • Investigatore principale:
          • Robert M. Eisner
      • Glenview, Illinois, Stati Uniti, 60026
        • Reclutamento
        • Northwestern Medicine Glenview Outpatient Center
        • Investigatore principale:
          • Yasmin Abaza
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 312-695-1102
      • Grayslake, Illinois, Stati Uniti, 60030
        • Reclutamento
        • Northwestern Medicine Grayslake Outpatient Center
        • Investigatore principale:
          • Yasmin Abaza
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 312-695-1102
      • Highland Park, Illinois, Stati Uniti, 60035
        • Reclutamento
        • NorthShore University HealthSystem-Highland Park Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 847-570-2109
        • Investigatore principale:
          • Robert M. Eisner
      • Hines, Illinois, Stati Uniti, 60141
        • Reclutamento
        • Edward Hines Jr VA Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 708-202-8387
        • Investigatore principale:
          • Jorgena Kosti-Schwartz
      • Lake Forest, Illinois, Stati Uniti, 60045
        • Reclutamento
        • Northwestern Medicine Lake Forest Hospital
        • Contatto:
        • Investigatore principale:
          • Yasmin Abaza
      • Mattoon, Illinois, Stati Uniti, 61938
        • Reclutamento
        • Carle Physician Group-Mattoon/Charleston
        • Investigatore principale:
          • Suparna Mantha
        • Contatto:
      • Maywood, Illinois, Stati Uniti, 60153
        • Reclutamento
        • Loyola University Medical Center
        • Investigatore principale:
          • Stephanie B. Tsai
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 708-226-4357
      • New Lenox, Illinois, Stati Uniti, 60451
        • Reclutamento
        • UC Comprehensive Cancer Center at Silver Cross
        • Contatto:
        • Investigatore principale:
          • Olatoyosi M. Odenike
      • O'Fallon, Illinois, Stati Uniti, 62269
        • Reclutamento
        • Cancer Care Center of O'Fallon
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Orland Park, Illinois, Stati Uniti, 60462
        • Reclutamento
        • University of Chicago Medicine-Orland Park
        • Contatto:
        • Investigatore principale:
          • Olatoyosi M. Odenike
      • Orland Park, Illinois, Stati Uniti, 60462
      • Shiloh, Illinois, Stati Uniti, 62269
        • Reclutamento
        • Memorial Hospital East
        • Contatto:
        • Investigatore principale:
          • Ramzi Abboud
      • Springfield, Illinois, Stati Uniti, 62702
        • Reclutamento
        • Southern Illinois University School of Medicine
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 217-545-7929
      • Springfield, Illinois, Stati Uniti, 62702
        • Reclutamento
        • Springfield Clinic
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-444-7541
      • Springfield, Illinois, Stati Uniti, 62781
        • Reclutamento
        • Springfield Memorial Hospital
        • Investigatore principale:
          • Bryan A. Faller
        • Contatto:
      • Urbana, Illinois, Stati Uniti, 61801
        • Reclutamento
        • Carle Cancer Center
        • Investigatore principale:
          • Suparna Mantha
        • Contatto:
      • Warrenville, Illinois, Stati Uniti, 60555
        • Reclutamento
        • Northwestern Medicine Cancer Center Warrenville
        • Contatto:
        • Investigatore principale:
          • Yasmin Abaza
    • Indiana
      • Crown Point, Indiana, Stati Uniti, 46307
        • Reclutamento
        • UChicago Medicine Northwest Indiana
        • Investigatore principale:
          • Olatoyosi M. Odenike
        • Contatto:
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Reclutamento
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 317-278-5632
          • Email: iutrials@iu.edu
        • Investigatore principale:
          • Rita Assi
    • Iowa
      • Iowa City, Iowa, Stati Uniti, 52242
        • Reclutamento
        • University of Iowa/Holden Comprehensive Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-237-1225
        • Investigatore principale:
          • Prajwal Dhakal
    • Kansas
      • Fairway, Kansas, Stati Uniti, 66205
        • Reclutamento
        • University of Kansas Clinical Research Center
        • Contatto:
        • Investigatore principale:
          • Jesus Gonzalez Lugo
      • Kansas City, Kansas, Stati Uniti, 66160
        • Reclutamento
        • University of Kansas Cancer Center
        • Contatto:
        • Investigatore principale:
          • Jesus Gonzalez Lugo
      • Overland Park, Kansas, Stati Uniti, 66211
        • Reclutamento
        • University of Kansas Hospital-Indian Creek Campus
        • Contatto:
        • Investigatore principale:
          • Jesus Gonzalez Lugo
      • Topeka, Kansas, Stati Uniti, 66606
        • Sospeso
        • Cotton O'Neil Cancer Center / Stormont Vail Health
      • Westwood, Kansas, Stati Uniti, 66205
        • Reclutamento
        • University of Kansas Hospital-Westwood Cancer Center
        • Contatto:
        • Investigatore principale:
          • Jesus Gonzalez Lugo
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40536
        • Reclutamento
        • University of Kentucky/Markey Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 859-257-3379
        • Investigatore principale:
          • Ayman Qasrawi
      • Louisville, Kentucky, Stati Uniti, 40202
        • Reclutamento
        • The James Graham Brown Cancer Center at University of Louisville
        • Investigatore principale:
          • Mohamed M. Hegazi
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 502-562-3429
      • Louisville, Kentucky, Stati Uniti, 40245
        • Reclutamento
        • UofL Health Medical Center Northeast
        • Investigatore principale:
          • Mohamed M. Hegazi
        • Contatto:
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70805
        • Reclutamento
        • LSU Health Baton Rouge-North Clinic
        • Contatto:
        • Investigatore principale:
          • Harry G. Sequeira Gross
      • Baton Rouge, Louisiana, Stati Uniti, 70808
        • Reclutamento
        • Our Lady of The Lake
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 225-765-7659
        • Investigatore principale:
          • Harry G. Sequeira Gross
      • Baton Rouge, Louisiana, Stati Uniti, 70808
        • Reclutamento
        • Our Lady of the Lake Physician Group
        • Contatto:
        • Investigatore principale:
          • Harry G. Sequeira Gross
    • Maine
      • Brunswick, Maine, Stati Uniti, 04011
        • Reclutamento
        • Mid Coast Hospital
        • Contatto:
        • Investigatore principale:
          • Pamela Egan
      • Brunswick, Maine, Stati Uniti, 04011
        • Reclutamento
        • MaineHealth Cancer Care and IV Therapy - Brunswick
        • Investigatore principale:
          • Pamela Egan
        • Contatto:
      • Portland, Maine, Stati Uniti, 04102
        • Reclutamento
        • MaineHealth Maine Medical Center - Portland
        • Investigatore principale:
          • Pamela Egan
        • Contatto:
      • Scarborough, Maine, Stati Uniti, 04074
        • Reclutamento
        • MaineHealth Maine Medical Center- Scarborough
        • Investigatore principale:
          • Pamela Egan
        • Contatto:
      • South Portland, Maine, Stati Uniti, 04106
        • Reclutamento
        • MaineHealth Cancer Care and IV Therapy - South Portland
        • Investigatore principale:
          • Pamela Egan
        • Contatto:
    • Maryland
      • Bethesda, Maryland, Stati Uniti, 20889-5600
        • Reclutamento
        • Walter Reed National Military Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 301-319-2100
        • Investigatore principale:
          • Ryan Jones
    • Massachusetts
      • Boston, Massachusetts, Stati Uniti, 02215
        • Reclutamento
        • Dana-Farber Cancer Institute
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 877-442-3324
        • Investigatore principale:
          • Eric S. Winer
      • Boston, Massachusetts, Stati Uniti, 02215
        • Reclutamento
        • Beth Israel Deaconess Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 617-667-9925
        • Investigatore principale:
          • Malgorzata McMasters
      • Boston, Massachusetts, Stati Uniti, 02111
      • Burlington, Massachusetts, Stati Uniti, 01805
      • Peabody, Massachusetts, Stati Uniti, 01960
        • Reclutamento
        • Lahey Clinic Peabody
        • Contatto:
        • Investigatore principale:
          • Hossein Sadrzadeh
    • Michigan
      • Brighton, Michigan, Stati Uniti, 48114
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Brighton
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Canton, Michigan, Stati Uniti, 48188
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Canton
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Chelsea, Michigan, Stati Uniti, 48118
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Clinton Township, Michigan, Stati Uniti, 48038
        • Attivo, non reclutante
        • Henry Ford Macomb Hospital-Clinton Township
      • Detroit, Michigan, Stati Uniti, 48202
        • Attivo, non reclutante
        • Henry Ford Hospital
      • Flint, Michigan, Stati Uniti, 48503
        • Reclutamento
        • Genesys Hurley Cancer Institute
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Flint, Michigan, Stati Uniti, 48503
        • Reclutamento
        • Hurley Medical Center
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Flint, Michigan, Stati Uniti, 48503
        • Sospeso
        • Genesee Hematology Oncology PC
      • Flint, Michigan, Stati Uniti, 48503
        • Reclutamento
        • Cancer Hematology Centers - Flint
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Jackson, Michigan, Stati Uniti, 49201
        • Attivo, non reclutante
        • Allegiance Health
      • Livonia, Michigan, Stati Uniti, 48154
        • Reclutamento
        • Trinity Health Saint Mary Mercy Livonia Hospital
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Novi, Michigan, Stati Uniti, 48377
        • Attivo, non reclutante
        • Henry Ford Medical Center-Columbus
      • Pontiac, Michigan, Stati Uniti, 48341
        • Reclutamento
        • Trinity Health Saint Joseph Mercy Oakland Hospital
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • West Bloomfield, Michigan, Stati Uniti, 48322
        • Attivo, non reclutante
        • Henry Ford West Bloomfield Hospital
      • Ypsilanti, Michigan, Stati Uniti, 48197
        • Reclutamento
        • Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
    • Minnesota
      • Coon Rapids, Minnesota, Stati Uniti, 55433
        • Reclutamento
        • Mercy Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Deer River, Minnesota, Stati Uniti, 56636
        • Reclutamento
        • Essentia Health - Deer River Clinic
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Duluth, Minnesota, Stati Uniti, 55805
        • Reclutamento
        • Essentia Health Cancer Center
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Edina, Minnesota, Stati Uniti, 55435
        • Reclutamento
        • Fairview Southdale Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Edina, Minnesota, Stati Uniti, 55435
        • Reclutamento
        • Minnesota Oncology - Edina
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Hibbing, Minnesota, Stati Uniti, 55746
        • Reclutamento
        • Essentia Health Hibbing Clinic
        • Investigatore principale:
          • Bret E. Friday
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 218-786-3308
      • Minneapolis, Minnesota, Stati Uniti, 55407
        • Reclutamento
        • Abbott-Northwestern Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Saint Louis Park, Minnesota, Stati Uniti, 55416
        • Reclutamento
        • Park Nicollet Clinic - Saint Louis Park
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Saint Paul, Minnesota, Stati Uniti, 55101
        • Reclutamento
        • Regions Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Saint Paul, Minnesota, Stati Uniti, 55102
        • Reclutamento
        • United Hospital
        • Contatto:
        • Investigatore principale:
          • David M. King
      • Sandstone, Minnesota, Stati Uniti, 55072
        • Reclutamento
        • Essentia Health Sandstone
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Virginia, Minnesota, Stati Uniti, 55792
        • Reclutamento
        • Essentia Health Virginia Clinic
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
    • Mississippi
      • Columbus, Mississippi, Stati Uniti, 39705
        • Reclutamento
        • Baptist Memorial Hospital and Cancer Center-Golden Triangle
        • Contatto:
        • Investigatore principale:
          • Muhammad Raza
      • Grenada, Mississippi, Stati Uniti, 38901
        • Reclutamento
        • Baptist Cancer Center-Grenada
        • Contatto:
        • Investigatore principale:
          • Muhammad Raza
      • New Albany, Mississippi, Stati Uniti, 38652
        • Reclutamento
        • Baptist Memorial Hospital and Cancer Center-Union County
        • Contatto:
        • Investigatore principale:
          • Muhammad Raza
      • Oxford, Mississippi, Stati Uniti, 38655
        • Reclutamento
        • Baptist Memorial Hospital and Cancer Center-Oxford
        • Contatto:
        • Investigatore principale:
          • Muhammad Raza
      • Southhaven, Mississippi, Stati Uniti, 38671
        • Reclutamento
        • Baptist Memorial Hospital and Cancer Center-Desoto
        • Contatto:
        • Investigatore principale:
          • Muhammad Raza
    • Missouri
      • City of Saint Peters, Missouri, Stati Uniti, 63376
        • Reclutamento
        • Siteman Cancer Center at Saint Peters Hospital
        • Contatto:
        • Investigatore principale:
          • Ramzi Abboud
      • Creve Coeur, Missouri, Stati Uniti, 63141
        • Reclutamento
        • Siteman Cancer Center at West County Hospital
        • Contatto:
        • Investigatore principale:
          • Ramzi Abboud
      • St Louis, Missouri, Stati Uniti, 63110
        • Reclutamento
        • Washington University School of Medicine
        • Contatto:
        • Investigatore principale:
          • Ramzi Abboud
      • St Louis, Missouri, Stati Uniti, 63129
        • Reclutamento
        • Siteman Cancer Center-South County
        • Contatto:
        • Investigatore principale:
          • Ramzi Abboud
      • St Louis, Missouri, Stati Uniti, 63136
        • Reclutamento
        • Siteman Cancer Center at Christian Hospital
        • Contatto:
        • Investigatore principale:
          • Ramzi Abboud
    • Montana
      • Anaconda, Montana, Stati Uniti, 59711
        • Reclutamento
        • Community Hospital of Anaconda
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Billings, Montana, Stati Uniti, 59101
        • Reclutamento
        • Billings Clinic Cancer Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Bozeman, Montana, Stati Uniti, 59715
        • Reclutamento
        • Bozeman Health Deaconess Hospital
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Great Falls, Montana, Stati Uniti, 59405
        • Reclutamento
        • Benefis Sletten Cancer Institute
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Kalispell, Montana, Stati Uniti, 59901
        • Reclutamento
        • Logan Health Medical Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
      • Missoula, Montana, Stati Uniti, 59804
        • Reclutamento
        • Community Medical Center
        • Investigatore principale:
          • John M. Schallenkamp
        • Contatto:
    • Nevada
      • Las Vegas, Nevada, Stati Uniti, 89102
        • Sospeso
        • OptumCare Cancer Care at Charleston
      • Las Vegas, Nevada, Stati Uniti, 89183
        • Sospeso
        • OptumCare Cancer Care at Fort Apache
    • New Hampshire
      • Lebanon, New Hampshire, Stati Uniti, 03756
        • Reclutamento
        • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
        • Contatto:
        • Investigatore principale:
          • Raphael A. Lizcano
    • New Jersey
      • Basking Ridge, New Jersey, Stati Uniti, 07920
        • Reclutamento
        • Memorial Sloan Kettering Basking Ridge
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Aaron D. Goldberg
      • Livingston, New Jersey, Stati Uniti, 07039
        • Reclutamento
        • Cooperman Barnabas Medical Center
        • Investigatore principale:
          • Neil D. Palmisiano
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 973-322-5200
      • Long Branch, New Jersey, Stati Uniti, 07740
        • Reclutamento
        • Monmouth Medical Center
        • Investigatore principale:
          • Neil D. Palmisiano
        • Contatto:
      • Middletown, New Jersey, Stati Uniti, 07748
        • Reclutamento
        • Memorial Sloan Kettering Monmouth
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Aaron D. Goldberg
      • Montvale, New Jersey, Stati Uniti, 07645
        • Reclutamento
        • Memorial Sloan Kettering Bergen
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Aaron D. Goldberg
      • New Brunswick, New Jersey, Stati Uniti, 08903
        • Reclutamento
        • Rutgers Cancer Institute of New Jersey
        • Investigatore principale:
          • Neil D. Palmisiano
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 732-235-7356
      • Paramus, New Jersey, Stati Uniti, 07652
        • Reclutamento
        • The Valley Hospital - Luckow Pavilion
        • Investigatore principale:
          • Jason Suh
        • Contatto:
      • Ridgewood, New Jersey, Stati Uniti, 07450
        • Reclutamento
        • Valley Health System Ridgewood Campus
        • Investigatore principale:
          • Jason Suh
        • Contatto:
      • Toms River, New Jersey, Stati Uniti, 08755
        • Reclutamento
        • Community Medical Center
        • Investigatore principale:
          • Neil D. Palmisiano
        • Contatto:
    • New Mexico
      • Albuquerque, New Mexico, Stati Uniti, 87106
        • Reclutamento
        • University of New Mexico Cancer Center
        • Contatto:
        • Investigatore principale:
          • Charles Foucar
    • New York
      • Buffalo, New York, Stati Uniti, 14263
        • Reclutamento
        • Roswell Park Cancer Institute
        • Investigatore principale:
          • Eunice S. Wang
        • Contatto:
      • Commack, New York, Stati Uniti, 11725
        • Reclutamento
        • Memorial Sloan Kettering Commack
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Aaron D. Goldberg
      • Lake Success, New York, Stati Uniti, 11042
        • Reclutamento
        • Northwell Health/Center for Advanced Medicine
        • Investigatore principale:
          • Erin Jou
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 516-734-8896
      • Manhasset, New York, Stati Uniti, 11030
        • Reclutamento
        • North Shore University Hospital
        • Investigatore principale:
          • Erin Jou
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 516-734-8896
      • New York, New York, Stati Uniti, 10065
        • Reclutamento
        • Memorial Sloan Kettering Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 212-639-7592
        • Investigatore principale:
          • Aaron D. Goldberg
      • Rochester, New York, Stati Uniti, 14642
        • Reclutamento
        • University of Rochester
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 585-275-5830
        • Investigatore principale:
          • Eric J. Huselton
      • Stony Brook, New York, Stati Uniti, 11794
        • Reclutamento
        • Stony Brook University Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-862-2215
        • Investigatore principale:
          • Suhu Liu
      • Syracuse, New York, Stati Uniti, 13210
        • Reclutamento
        • State University of New York Upstate Medical University
        • Investigatore principale:
          • Teresa C. Gentile
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 315-464-5476
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599
        • Sospeso
        • UNC Lineberger Comprehensive Cancer Center
      • Charlotte, North Carolina, Stati Uniti, 28203
        • Reclutamento
        • Carolinas Medical Center/Levine Cancer Institute
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-9376
        • Investigatore principale:
          • Michael R. Grunwald
      • Durham, North Carolina, Stati Uniti, 27710
        • Reclutamento
        • Duke University Medical Center
        • Investigatore principale:
          • Harry P. Erba
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 888-275-3853
      • Greenville, North Carolina, Stati Uniti, 27834
        • Reclutamento
        • East Carolina University
        • Investigatore principale:
          • Darla K. Liles
        • Contatto:
      • Winston-Salem, North Carolina, Stati Uniti, 27157
        • Reclutamento
        • Wake Forest University Health Sciences
        • Investigatore principale:
          • Timothy S. Pardee
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 336-713-6771
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44106
        • Reclutamento
        • Case Western Reserve University
        • Investigatore principale:
          • Ali W. Bseiso
        • Contatto:
      • Columbus, Ohio, Stati Uniti, 43210
        • Reclutamento
        • Ohio State University Comprehensive Cancer Center
        • Contatto:
        • Investigatore principale:
          • Jayanshu Jain
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • Reclutamento
        • University of Oklahoma Health Sciences Center
        • Contatto:
        • Investigatore principale:
          • Mohamad Khawandanah
    • Oregon
      • Newberg, Oregon, Stati Uniti, 97132
        • Reclutamento
        • Providence Newberg Medical Center
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Ontario, Oregon, Stati Uniti, 97914
        • Reclutamento
        • Saint Alphonsus Cancer Care Center-Ontario
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Oregon City, Oregon, Stati Uniti, 97045
        • Reclutamento
        • Providence Willamette Falls Medical Center
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Portland, Oregon, Stati Uniti, 97213
        • Reclutamento
        • Providence Portland Medical Center
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Portland, Oregon, Stati Uniti, 97225
        • Reclutamento
        • Providence Saint Vincent Medical Center
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
    • Pennsylvania
      • Allentown, Pennsylvania, Stati Uniti, 18103
        • Reclutamento
        • Lehigh Valley Hospital-Cedar Crest
        • Contatto:
        • Investigatore principale:
          • Tareq Al baghdadi
      • Danville, Pennsylvania, Stati Uniti, 17822
        • Reclutamento
        • Geisinger Medical Center
        • Investigatore principale:
          • Joseph J. Vadakara
        • Contatto:
      • Hershey, Pennsylvania, Stati Uniti, 17033-0850
        • Reclutamento
        • Penn State Milton S Hershey Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 717-531-3779
          • Email: CTO@hmc.psu.edu
        • Investigatore principale:
          • Joseph Cioccio
      • Philadelphia, Pennsylvania, Stati Uniti, 19104
        • Reclutamento
        • University of Pennsylvania/Abramson Cancer Center
        • Investigatore principale:
          • Alexander E. Perl
        • Contatto:
      • Pittsburgh, Pennsylvania, Stati Uniti, 15232
        • Reclutamento
        • UPMC Hillman Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 412-647-8073
        • Investigatore principale:
          • Annie P. Im
      • West Reading, Pennsylvania, Stati Uniti, 19611
        • Reclutamento
        • Reading Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 610-988-9323
        • Investigatore principale:
          • Terrence P. Cescon
      • Wilkes-Barre, Pennsylvania, Stati Uniti, 18711
        • Reclutamento
        • Geisinger Wyoming Valley/Henry Cancer Center
        • Contatto:
        • Investigatore principale:
          • Joseph J. Vadakara
    • Rhode Island
      • Providence, Rhode Island, Stati Uniti, 02903
        • Reclutamento
        • Rhode Island Hospital
        • Investigatore principale:
          • John L. Reagan
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 401-444-1488
    • South Carolina
      • Boiling Springs, South Carolina, Stati Uniti, 29316
        • Reclutamento
        • Prisma Health Cancer Institute - Spartanburg
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Charleston, South Carolina, Stati Uniti, 29425
        • Reclutamento
        • Medical University of South Carolina
        • Investigatore principale:
          • Praneeth Baratam
        • Contatto:
      • Easley, South Carolina, Stati Uniti, 29640
        • Reclutamento
        • Prisma Health Cancer Institute - Easley
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Greenville, South Carolina, Stati Uniti, 29605
        • Reclutamento
        • Prisma Health Cancer Institute - Faris
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Greenville, South Carolina, Stati Uniti, 29605
        • Reclutamento
        • Prisma Health Cancer Institute - Butternut
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Greenville, South Carolina, Stati Uniti, 29615
        • Reclutamento
        • Prisma Health Cancer Institute - Eastside
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Greer, South Carolina, Stati Uniti, 29650
        • Reclutamento
        • Prisma Health Cancer Institute - Greer
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
      • Seneca, South Carolina, Stati Uniti, 29672
        • Reclutamento
        • Prisma Health Cancer Institute - Seneca
        • Investigatore principale:
          • Suzanne R. Fanning
        • Contatto:
    • Tennessee
      • Collierville, Tennessee, Stati Uniti, 38017
        • Reclutamento
        • Baptist Memorial Hospital and Cancer Center-Collierville
        • Contatto:
        • Investigatore principale:
          • Muhammad Raza
      • Knoxville, Tennessee, Stati Uniti, 37920
        • Sospeso
        • University of Tennessee - Knoxville
      • Memphis, Tennessee, Stati Uniti, 38120
        • Reclutamento
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Contatto:
        • Investigatore principale:
          • Muhammad Raza
    • Texas
      • Houston, Texas, Stati Uniti, 77030
        • Reclutamento
        • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 713-798-1354
          • Email: burton@bcm.edu
        • Investigatore principale:
          • Tareq Abuasab
      • Houston, Texas, Stati Uniti, 77030
        • Reclutamento
        • Ben Taub General Hospital
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 713-873-2000
        • Investigatore principale:
          • Tareq Abuasab
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84112
        • Reclutamento
        • Huntsman Cancer Institute/University of Utah
        • Contatto:
        • Investigatore principale:
          • Paul J. Shami
      • Salt Lake City, Utah, Stati Uniti, 84148
        • Reclutamento
        • George E Wahlen Department of Veterans Affairs Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 801-582-1565
        • Investigatore principale:
          • Tsewang Tashi
    • Vermont
      • Burlington, Vermont, Stati Uniti, 05401
        • Reclutamento
        • University of Vermont Medical Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 802-656-4101
          • Email: rpo@uvm.edu
        • Investigatore principale:
          • Diego A. Adrianzen Herrera
      • Burlington, Vermont, Stati Uniti, 05405
        • Reclutamento
        • University of Vermont and State Agricultural College
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 802-656-8990
          • Email: rpo@uvm.edu
        • Investigatore principale:
          • Diego A. Adrianzen Herrera
    • Virginia
      • Charlottesville, Virginia, Stati Uniti, 22908
        • Reclutamento
        • University of Virginia Cancer Center
        • Investigatore principale:
          • Daniel R. Reed
        • Contatto:
      • Richmond, Virginia, Stati Uniti, 23298
        • Reclutamento
        • VCU Massey Comprehensive Cancer Center
        • Investigatore principale:
          • Keri R. Maher
        • Contatto:
    • Washington
      • Edmonds, Washington, Stati Uniti, 98026
        • Reclutamento
        • Swedish Cancer Institute-Edmonds
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Issaquah, Washington, Stati Uniti, 98029
        • Reclutamento
        • Swedish Cancer Institute-Issaquah
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Seattle, Washington, Stati Uniti, 98122
        • Reclutamento
        • Swedish Medical Center-First Hill
        • Investigatore principale:
          • Alison K. Conlin
        • Contatto:
      • Seattle, Washington, Stati Uniti, 98195
        • Reclutamento
        • University of Washington Medical Center - Montlake
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-8824
        • Investigatore principale:
          • Jacob S. Appelbaum
      • Seattle, Washington, Stati Uniti, 98109
        • Reclutamento
        • Fred Hutchinson Cancer Center
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 800-804-8824
        • Investigatore principale:
          • Jacob S. Appelbaum
    • Wisconsin
      • Appleton, Wisconsin, Stati Uniti, 54911
        • Reclutamento
        • ThedaCare Regional Cancer Center
        • Contatto:
        • Investigatore principale:
          • Yazhini Vallatharasu
      • Ashland, Wisconsin, Stati Uniti, 54806
        • Reclutamento
        • Duluth Clinic Ashland
        • Contatto:
        • Investigatore principale:
          • Bret E. Friday
      • Green Bay, Wisconsin, Stati Uniti, 54301
        • Reclutamento
        • Saint Vincent Hospital Cancer Center Green Bay
        • Investigatore principale:
          • Brian L. Burnette
        • Contatto:
      • Green Bay, Wisconsin, Stati Uniti, 54303
        • Reclutamento
        • Saint Vincent Hospital Cancer Center at Saint Mary's
        • Investigatore principale:
          • Brian L. Burnette
        • Contatto:
      • La Crosse, Wisconsin, Stati Uniti, 54601
        • Reclutamento
        • Gundersen Lutheran Medical Center
        • Contatto:
        • Investigatore principale:
          • Kurt Oettel
      • Madison, Wisconsin, Stati Uniti, 53705
        • Reclutamento
        • William S Middleton VA Medical Center
        • Investigatore principale:
          • Christopher D. Fletcher
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 17007 608-256-1901
      • Madison, Wisconsin, Stati Uniti, 53792
        • Reclutamento
        • University of Wisconsin Carbone Cancer Center - University Hospital
        • Investigatore principale:
          • Kieran D. Sahasrabudhe
        • Contatto:
      • Madison, Wisconsin, Stati Uniti, 53718
        • Reclutamento
        • University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
        • Investigatore principale:
          • Kieran D. Sahasrabudhe
        • Contatto:
      • Milwaukee, Wisconsin, Stati Uniti, 53226
        • Reclutamento
        • Medical College of Wisconsin
        • Contatto:
          • Site Public Contact
          • Numero di telefono: 414-805-3666
        • Investigatore principale:
          • Sameem M. Abedin
      • Oconto Falls, Wisconsin, Stati Uniti, 54154
        • Reclutamento
        • Saint Vincent Hospital Cancer Center at Oconto Falls
        • Investigatore principale:
          • Brian L. Burnette
        • Contatto:
      • Sheboygan, Wisconsin, Stati Uniti, 53081
        • Reclutamento
        • Saint Vincent Hospital Cancer Center at Sheboygan
        • Investigatore principale:
          • Brian L. Burnette
        • Contatto:
      • Stevens Point, Wisconsin, Stati Uniti, 54482
      • Sturgeon Bay, Wisconsin, Stati Uniti, 54235-1495
        • Reclutamento
        • Saint Vincent Hospital Cancer Center at Sturgeon Bay
        • Investigatore principale:
          • Brian L. Burnette
        • Contatto:
      • Weston, Wisconsin, Stati Uniti, 54476

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Patient must be ≥ 60 years of age or adults ˂ 60 who in the opinion of the treating physician are better served by azanucleoside-based therapy rather than intensive, cytarabine-based induction based on clinical status (i.e., performance status), organ dysfunction, or disease biology

  • Patient must have a morphologically confirmed diagnosis of AML as determined by the site and confirmed by the treatment verification team, excluding acute promyelocytic leukemia (APL) with PML-RARA, AML with RUNX1-RUNX1T1, or AML with CBFB-MYH11

  • Patient must have no prior therapy for AML with the exception of hydroxyurea, all-trans retinoic acid (ATRA), cytarabine-based emergency therapy or leukapheresis to ensure white blood cells (WBC) < 25,000/mm^3 prior to starting venetoclax treatment

  • Patient must have no prior therapy with hypomethylating agents or FLT3 inhibitors

  • Patient must have the FLT3-ITD, D835, or I836del mutation based on MYELOMATCH Protocol

  • Patient must be assigned to this protocol by the MYELOMATCH Protocol

  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)

  • Patients must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Contraception measures must continue for 30 days after the last dose of venetoclax for all patients who are able to conceive or father children and for 6 months after the last dose of gilteritinib for patients of childbearing potential and for 4 months after the last dose of gilteritinib for male patients with partners of childbearing potential. Patient must not breastfeed during treatment and for 2 months after treatment ends

  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible

  • Total bilirubin ≤ 2 X institutional upper limit of normal (ULN), unless thought to be elevated due to disease involvement or Gilbert's syndrome, in which case bilirubin ≤ 3 x ULN is allowed (must be obtained ≤ 14 days prior to randomization)

  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3.0 x institutional ULN (must be obtained ≤ 14 days prior to randomization)

  • Creatinine clearance ≥ 30 mL/min (must be obtained ≤ 14 days prior to randomization)

    • Either measured or estimated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Creatinine Equation (2021)

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial

  • Patients who meet the criteria below must have had an electrocardiogram (ECG) performed with a corrected QT interval using Fridericia's correction (QTcF) interval within normal limits:

    • History of cardiac arrythmia, atrial fibrillation, or irregular QTcF interval OR

    • Known genetic predisposition to long QT syndrome OR

    • Risk for electrolyte abnormalities, including tumor lysis syndrome

      • Normal limits are QTcF ≤ 450 ms for males and QTcF ≤ 460 ms for females. Corrected QT interval method (QTcF) may follow institutional standards
      • NOTE: Since older patients and patients with cardiac disease are at risk for prolonged QTcF and many will require supportive care with agents that affect the QTcF, an ECG is recommended if clinically indicated as noted above. If the QTcF is prolonged (> 450 ms for males and > 460 ms for females), they should be treated on the Tier Advancement Pathway (TAP) instead of MM1OA-EA02. In patients where ECG is not clinically indicated, QTcF does not need to be documented

  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated

  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

  • Patient must not have the medical necessity for ongoing treatment with a strong CYP3A4 inducing drug

  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial

  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2 or better

  • Patient must not have an uncontrolled infection

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Regimen 1 (azacitidine, venetoclax)

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 of each cycle and venetoclax PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Droga: Venetoclax

Given PO

Altri nomi:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclixto
  • 199 circa
  • GDC 0199
  • GDC0199
Procedura: Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

Procedura: Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

Altri nomi:
  • Biopsia del midollo osseo
  • Biopsia, midollo osseo
Droga: Azacitidine

Given IV or SC

Altri nomi:
  • 5AZC
  • 5-AC
  • 5-azacitidina
  • 5-AZC
  • Azacitidina
  • Azacitidina, 5-
  • Ladakamicina
  • Milosar
  • U-18496
  • Vidazza
Sperimentale: Regimen 2 (azacitidine, venetoclax, gilteritinib)

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax and gilteritinib PO on days 1-28 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-7 and gilteritinib PO on days 1-28 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Droga: Venetoclax

Given PO

Altri nomi:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclixto
  • 199 circa
  • GDC 0199
  • GDC0199
Procedura: Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

Procedura: Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

Altri nomi:
  • Biopsia del midollo osseo
  • Biopsia, midollo osseo
Droga: Azacitidine

Given IV or SC

Altri nomi:
  • 5AZC
  • 5-AC
  • 5-azacitidina
  • 5-AZC
  • Azacitidina
  • Azacitidina, 5-
  • Ladakamicina
  • Milosar
  • U-18496
  • Vidazza
Droga: Gilteritinib

Given PO

Altri nomi:
  • ASP2215
  • ASP-2215
Sperimentale: Regimen 3 (azacitidine, venetoclax, gilteritinib)

INDUCTION: Patients receive azacitidine IV or SC on days 1-7 and venetoclax PO on days 1-28, and gilteritinib PO on days 8-21 of each cycle. Treatment repeats every 28 days for up to 2 cycles or until bone marrow assessment shows at least an MLFS response or better ("better" defined as CR, CRi, CRh), in the absence of disease progression or unacceptable toxicity.

CONSOLIDATION: Patients receive azacitidine IV or SC on days 1-5, venetoclax PO on days 1-14 and gilteritinib PO on days 8-21 of each cycle. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity.

Patients undergo bone marrow biopsy and aspiration as well as blood sample collection on the trial.
Procedura: Biospecimen Collection

Undergo blood sample collection

Altri nomi:
  • Raccolta di campioni biologici
  • Biocampione raccolto
  • Raccolta di campioni
  • Raccolta campione
Droga: Venetoclax

Given PO

Altri nomi:
  • Venclexta
  • ABT-0199
  • ABT-199
  • ABT199
  • GDC-0199
  • RG7601
  • Venclixto
  • 199 circa
  • GDC 0199
  • GDC0199
Procedura: Bone Marrow Aspiration

Undergo bone marrow biopsy and aspiration

Procedura: Bone Marrow Biopsy

Undergo bone marrow biopsy and aspiration

Altri nomi:
  • Biopsia del midollo osseo
  • Biopsia, midollo osseo
Droga: Azacitidine

Given IV or SC

Altri nomi:
  • 5AZC
  • 5-AC
  • 5-azacitidina
  • 5-AZC
  • Azacitidina
  • Azacitidina, 5-
  • Ladakamicina
  • Milosar
  • U-18496
  • Vidazza
Droga: Gilteritinib

Given PO

Altri nomi:
  • ASP2215
  • ASP-2215

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of measured residual disease (MRD) negative complete remission (CR)
Lasso di tempo: Up to 4 cycles of treatment (1 cycle = 28 days)

Will be assessed by multiparameter flow cytometry at a level of ≤ 1 residual blast / 1,000 leukocytes (≤ 10^-3). Patients achieved MRD negative CR at any time up to 4 cycles will count as a responder. The MRD negative CR frequencies will be compared between each triplet regimen and the control regimen using Fisher's exact test with one-sided alpha of 0.05 for each comparison. Test results with one-sided p-value < 0.05 will be considered statistically significant.
Up to 4 cycles of treatment (1 cycle = 28 days)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Rate of MRD negative CR/CR with incomplete count recovery (CRi)/CR with partial hematologic recovery (CRh)
Lasso di tempo: Up to 4 cycles of treatment (1 cycle = 28 days)

Patients who achieved MRD negative CR at any time up to 4 cycles will count as a responder. The MRD negative CR frequencies will be compared between each triplet regimen and the control regimen using Fisher's exact test with one-sided alpha of 0.05 for each comparison. Test results with one-sided p-value < 0.05 will be considered statistically significant.
Up to 4 cycles of treatment (1 cycle = 28 days)
Rate of CR
Lasso di tempo: Up to 10 years

The CR rates will be compared using Fisher's exact test. Only nominal p-values will be provided.
Up to 10 years
Rate of CRi
Lasso di tempo: Up to 10 years

The CR rates will be compared using Fisher's exact test. Only nominal p-values will be provided.
Up to 10 years
Rate of CRh
Lasso di tempo: Up to 10 years

The CR rates will be compared using Fisher's exact test. Only nominal p-values will be provided.
Up to 10 years
Overall survival
Lasso di tempo: Time between randomization and death from any cause, assessed up to 10 years

Will be calculated using the Kaplan-Meier method.
Time between randomization and death from any cause, assessed up to 10 years
Event-free survival
Lasso di tempo: Time from randomization to failure to achieve CR, CRi, and CRh, or to relapse after CR/CRi/CRh or to death in remission, assessed up to 10 years

Will be calculated using the Kaplan-Meier method.
Time from randomization to failure to achieve CR, CRi, and CRh, or to relapse after CR/CRi/CRh or to death in remission, assessed up to 10 years
Incidence of adverse events
Lasso di tempo: Up to 10 years

Will be determined using the Common Terminology Criteria for Adverse Events.
Up to 10 years

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

National Cancer Institute (NCI)

Investigatori

  • Investigatore principale: Jessica K Altman, ECOG-ACRIN Cancer Research Group

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

27 settembre 2024

Completamento primario (Stimato)

15 maggio 2029

Completamento dello studio (Stimato)

15 maggio 2029

Date di iscrizione allo studio

Primo inviato

16 marzo 2024

Primo inviato che soddisfa i criteri di controllo qualità

16 marzo 2024

Primo Inserito (Effettivo)

19 marzo 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • NCI-2024-01987
  • U10CA180820 (Sovvenzione/contratto NIH degli Stati Uniti)
  • NCI-2024-01987 (Identificatore di registro: CTRP (Clinical Trial Reporting Program))
  • MM1OA-EA02 (Altro identificatore: CTEP)
  • MM1OA-EA02 (Altro identificatore: ECOG-ACRIN Cancer Research Group)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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