Venetoclax and HMA Treatment of Older and Unfit Adults With FLT3 Mutated Acute Myeloid Leukemia (AML) (A MyeloMATCH Treatment Trial)
Start Date
9/27/2024
Completion Date
5/15/2029
Summary
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.
Detailed Description
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Azacitidine
Biospecimen Collection
Bone Marrow Aspiration
Bone Marrow Biopsy
Gilteritinib
Venetoclax
Conditions
Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United States
Banner University Medical Center - Tucson
Tucson, Arizona 85719
United States
University of Arizona Cancer Center-North Campus
Tucson, Arizona 85719
United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
United States
Alta Bates Summit Medical Center-Herrick Campus
Berkeley, California 94704
United States
Kaiser Permanente Dublin
Dublin, California 94568
United States
Kaiser Permanente-Fremont
Fremont, California 94538
United States
Kaiser Permanente Fresno Orchard Plaza
Fresno, California 93720
United States
Kaiser Permanente-Fresno
Fresno, California 93720
United States
Cedars-Sinai Medical Center
Los Angeles, California 90048
United States
Kaiser Permanente- Modesto MOB II
Modesto, California 95356
United States
Kaiser Permanente-Modesto
Modesto, California 95356
United States
Kaiser Permanente-Oakland
Oakland, California 94611
United States
Kaiser Permanente-Roseville
Roseville, California 95661
United States
Kaiser Permanente Downtown Commons
Sacramento, California 95814
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Kaiser Permanente-South Sacramento
Sacramento, California 95823
United States
Kaiser Permanente-San Francisco
San Francisco, California 94115
United States
UCSF Medical Center-Parnassus
San Francisco, California 94143
United States
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
United States
Kaiser Permanente San Leandro
San Leandro, California 94577
United States
Mills Health Center
San Mateo, California 94401
United States
Kaiser San Rafael-Gallinas
San Rafael, California 94903
United States
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
United States
Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
United States
Kaiser Permanente-South San Francisco
South San Francisco, California 94080
United States
Kaiser Permanente-Vallejo
Vallejo, California 94589
United States
Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
United States
Yale University
New Haven, Connecticut 06520
United States
Veterans Affairs Connecticut Healthcare System-West Haven Campus
West Haven, Connecticut 06516
United States
UF Health Cancer Institute - Gainesville
Gainesville, Florida 32610
United States
Miami Cancer Institute
Miami, Florida 33176
United States
Phoebe Putney Memorial Hospital
Albany, Georgia 31701
United States
Augusta University Medical Center
Augusta, Georgia 30912
United States
Hawaii Cancer Care Inc - Waterfront Plaza
Honolulu, Hawaii 96813
United States
Straub Clinic and Hospital
Honolulu, Hawaii 96813
United States
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii 96819
United States
Hawaii Cancer Care - Westridge
‘Aiea, Hawaii 96701
United States
Pali Momi Medical Center
‘Aiea, Hawaii 96701
United States
Saint Alphonsus Cancer Care Center-Boise
Boise, Idaho 83706
United States
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
United States
Saint Alphonsus Cancer Care Center-Caldwell
Caldwell, Idaho 83605
United States
Kootenai Health - Coeur d'Alene
Coeur d'Alene, Idaho 83814
United States
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
United States
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
United States
Saint Alphonsus Cancer Care Center-Nampa
Nampa, Idaho 83687
United States
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
United States
Kootenai Clinic Cancer Services - Post Falls
Post Falls, Idaho 83854
United States
Kootenai Clinic Cancer Services - Sandpoint
Sandpoint, Idaho 83864
United States
Northwestern University
Chicago, Illinois 60611
United States
University of Illinois
Chicago, Illinois 60612
United States
University of Chicago Comprehensive Cancer Center
Chicago, Illinois 60637
United States
Carle at The Riverfront
Danville, Illinois 61832
United States
Cancer Care Specialists of Illinois - Decatur
Decatur, Illinois 62526
United States
Decatur Memorial Hospital
Decatur, Illinois 62526
United States
Northwestern Medicine Cancer Center Kishwaukee
DeKalb, Illinois 60115
United States
Carle Physician Group-Effingham
Effingham, Illinois 62401
United States
Crossroads Cancer Center
Effingham, Illinois 62401
United States
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois 60201
United States
Northwestern Medicine Cancer Center Delnor
Geneva, Illinois 60134
United States
NorthShore University HealthSystem-Glenbrook Hospital
Glenview, Illinois 60026
United States
Northwestern Medicine Glenview Outpatient Center
Glenview, Illinois 60026
United States
Northwestern Medicine Grayslake Outpatient Center
Grayslake, Illinois 60030
United States
NorthShore University HealthSystem-Highland Park Hospital
Highland Park, Illinois 60035
United States
Edward Hines Jr VA Hospital
Hines, Illinois 60141
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
United States
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United States
Loyola University Medical Center
Maywood, Illinois 60153
United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
United States
Cancer Care Center of O'Fallon
O'Fallon, Illinois 62269
United States
Northwestern Medicine Orland Park
Orland Park, Illinois 60462
United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
United States
Memorial Hospital East
Shiloh, Illinois 62269
United States
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Springfield Clinic
Springfield, Illinois 62702
United States
Springfield Memorial Hospital
Springfield, Illinois 62781
United States
Carle Cancer Center
Urbana, Illinois 61801
United States
Northwestern Medicine Cancer Center Warrenville
Warrenville, Illinois 60555
United States
UChicago Medicine Northwest Indiana
Crown Point, Indiana 46307
United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa 52242
United States
University of Kansas Clinical Research Center
Fairway, Kansas 66205
United States
University of Kansas Cancer Center
Kansas City, Kansas 66160
United States
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas 66211
United States
Cotton O'Neil Cancer Center / Stormont Vail Health
Topeka, Kansas 66606
United States
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas 66205
United States
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United States
The James Graham Brown Cancer Center at University of Louisville
Louisville, Kentucky 40202
United States
UofL Health Medical Center Northeast
Louisville, Kentucky 40245
United States
LSU Health Baton Rouge-North Clinic
Baton Rouge, Louisiana 70805
United States
Our Lady of the Lake Physician Group
Baton Rouge, Louisiana 70808
United States
Our Lady of The Lake
Baton Rouge, Louisiana 70808
United States
MaineHealth Cancer Care and IV Therapy - Brunswick
Brunswick, Maine 04011
United States
Mid Coast Hospital
Brunswick, Maine 04011
United States
MaineHealth Maine Medical Center - Portland
Portland, Maine 04102
United States
MaineHealth Maine Medical Center- Scarborough
Scarborough, Maine 04074
United States
MaineHealth Cancer Care and IV Therapy - South Portland
South Portland, Maine 04106
United States
Walter Reed National Military Medical Center
Bethesda, Maryland 20889-5600
United States
Tufts Medical Center
Boston, Massachusetts 02111
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United States
Dana-Farber Cancer Institute
Boston, Massachusetts 02215
United States
Lahey Clinic
Burlington, Massachusetts 01805
United States
Lahey Clinic Peabody
Peabody, Massachusetts 01960
United States
Trinity Health IHA Medical Group Hematology Oncology - Brighton
Brighton, Michigan 48114
United States
Trinity Health IHA Medical Group Hematology Oncology - Canton
Canton, Michigan 48188
United States
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital
Chelsea, Michigan 48118
United States
Henry Ford Macomb Hospital-Clinton Township
Clinton Township, Michigan 48038
United States
Henry Ford Hospital
Detroit, Michigan 48202
United States
Cancer Hematology Centers - Flint
Flint, Michigan 48503
United States
Genesee Hematology Oncology PC
Flint, Michigan 48503
United States
Genesys Hurley Cancer Institute
Flint, Michigan 48503
United States
Hurley Medical Center
Flint, Michigan 48503
United States
Allegiance Health
Jackson, Michigan 49201
United States
Trinity Health Saint Mary Mercy Livonia Hospital
Livonia, Michigan 48154
United States
Henry Ford Medical Center-Columbus
Novi, Michigan 48377
United States
Trinity Health Saint Joseph Mercy Oakland Hospital
Pontiac, Michigan 48341
United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan 48322
United States
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus
Ypsilanti, Michigan 48197
United States
Mercy Hospital
Coon Rapids, Minnesota 55433
United States
Essentia Health - Deer River Clinic
Deer River, Minnesota 56636
United States
Essentia Health Cancer Center
Duluth, Minnesota 55805
United States
Fairview Southdale Hospital
Edina, Minnesota 55435
United States
Essentia Health Hibbing Clinic
Hibbing, Minnesota 55746
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
United States
Regions Hospital
Saint Paul, Minnesota 55101
United States
United Hospital
Saint Paul, Minnesota 55102
United States
Essentia Health Sandstone
Sandstone, Minnesota 55072
United States
Essentia Health Virginia Clinic
Virginia, Minnesota 55792
United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Columbus, Mississippi 39705
United States
Baptist Cancer Center-Grenada
Grenada, Mississippi 38901
United States
Baptist Memorial Hospital and Cancer Center-Union County
New Albany, Mississippi 38652
United States
Baptist Memorial Hospital and Cancer Center-Oxford
Oxford, Mississippi 38655
United States
Baptist Memorial Hospital and Cancer Center-Desoto
Southhaven, Mississippi 38671
United States
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri 63376
United States
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Siteman Cancer Center-South County
St Louis, Missouri 63129
United States
Siteman Cancer Center at Christian Hospital
St Louis, Missouri 63136
United States
Community Hospital of Anaconda
Anaconda, Montana 59711
United States
Billings Clinic Cancer Center
Billings, Montana 59101
United States
Bozeman Health Deaconess Hospital
Bozeman, Montana 59715
United States
Benefis Sletten Cancer Institute
Great Falls, Montana 59405
United States
Logan Health Medical Center
Kalispell, Montana 59901
United States
Community Medical Center
Missoula, Montana 59804
United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89183
United States
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
United States
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United States
Cooperman Barnabas Medical Center
Livingston, New Jersey 07039
United States
Monmouth Medical Center
Long Branch, New Jersey 07740
United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United States
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey 08903
United States
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey 07652
United States
Valley Health System Ridgewood Campus
Ridgewood, New Jersey 07450
United States
Community Medical Center
Toms River, New Jersey 08755
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Memorial Sloan Kettering Commack
Commack, New York 11725
United States
Northwell Health/Center for Advanced Medicine
Lake Success, New York 11042
United States
North Shore University Hospital
Manhasset, New York 11030
United States
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United States
University of Rochester
Rochester, New York 14642
United States
Stony Brook University Medical Center
Stony Brook, New York 11794
United States
State University of New York Upstate Medical University
Syracuse, New York 13210
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Carolinas Medical Center/Levine Cancer Institute
Charlotte, North Carolina 28203
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
East Carolina University
Greenville, North Carolina 27834
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Case Western Reserve University
Cleveland, Ohio 44106
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Providence Newberg Medical Center
Newberg, Oregon 97132
United States
Saint Alphonsus Cancer Care Center-Ontario
Ontario, Oregon 97914
United States
Providence Willamette Falls Medical Center
Oregon City, Oregon 97045
United States
Providence Portland Medical Center
Portland, Oregon 97213
United States
Providence Saint Vincent Medical Center
Portland, Oregon 97225
United States
Lehigh Valley Hospital-Cedar Crest
Allentown, Pennsylvania 18103
United States
Geisinger Medical Center
Danville, Pennsylvania 17822
United States
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania 17033-0850
United States
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania 19104
United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
United States
Reading Hospital
West Reading, Pennsylvania 19611
United States
Geisinger Wyoming Valley/Henry Cancer Center
Wilkes-Barre, Pennsylvania 18711
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Prisma Health Cancer Institute - Spartanburg
Boiling Springs, South Carolina 29316
United States
Medical University of South Carolina
Charleston, South Carolina 29425
United States
Prisma Health Cancer Institute - Easley
Easley, South Carolina 29640
United States
Prisma Health Cancer Institute - Butternut
Greenville, South Carolina 29605
United States
Prisma Health Cancer Institute - Faris
Greenville, South Carolina 29605
United States
Prisma Health Cancer Institute - Eastside
Greenville, South Carolina 29615
United States
Prisma Health Cancer Institute - Greer
Greer, South Carolina 29650
United States
Prisma Health Cancer Institute - Seneca
Seneca, South Carolina 29672
United States
Baptist Memorial Hospital and Cancer Center-Collierville
Collierville, Tennessee 38017
United States
University of Tennessee - Knoxville
Knoxville, Tennessee 37920
United States
Baptist Memorial Hospital and Cancer Center-Memphis
Memphis, Tennessee 38120
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United States
Ben Taub General Hospital
Houston, Texas 77030
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States
George E Wahlen Department of Veterans Affairs Medical Center
Salt Lake City, Utah 84148
United States
University of Vermont Medical Center
Burlington, Vermont 05401
United States
University of Vermont and State Agricultural College
Burlington, Vermont 05405
United States
University of Virginia Cancer Center
Charlottesville, Virginia 22908
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
Swedish Cancer Institute-Edmonds
Edmonds, Washington 98026
United States
Swedish Cancer Institute-Issaquah
Issaquah, Washington 98029
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
Swedish Medical Center-First Hill
Seattle, Washington 98122
United States
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United States
ThedaCare Regional Cancer Center
Appleton, Wisconsin 54911
United States
Duluth Clinic Ashland
Ashland, Wisconsin 54806
United States
Saint Vincent Hospital Cancer Center Green Bay
Green Bay, Wisconsin 54301
United States
Saint Vincent Hospital Cancer Center at Saint Mary's
Green Bay, Wisconsin 54303
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
United States
William S Middleton VA Medical Center
Madison, Wisconsin 53705
United States
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center
Madison, Wisconsin 53718
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United States
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States
Saint Vincent Hospital Cancer Center at Oconto Falls
Oconto Falls, Wisconsin 54154
United States
Saint Vincent Hospital Cancer Center at Sheboygan
Sheboygan, Wisconsin 53081
United States
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Sturgeon Bay, Wisconsin 54235-1495
United States
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
United States
Centro Comprensivo de Cancer de UPR
San Juan, 00927
Puerto Rico
San Juan City Hospital
San Juan, 00936
Puerto Rico