Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)
Start Date
2/8/2021
Completion Date
8/1/2028
Summary
This phase I/II trial studies the safety, side effects and best dose of OBI-3424 and how well it works in treating patients with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Chemotherapy drugs, such as OBI-3424, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. OBI-3424 may reduce the amount of leukemia in the body.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the safety of AKR1C3-activated prodrug OBI-3424 (OBI-3424) and to determine the maximum tolerated dose (MTD) of OBI-3424 in this regimen for patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL)/T-cell lymphoblastic lymphoma (T-LBL). (Phase I) II. To assess the response rate (complete remission \[CR\] or CR with incomplete count recovery \[CRi\]) of patients treated with OBI-3424 at the maximum tolerated dose (MTD) determined in the Phase I portion of the trial in this patient population. (Phase II) SECONDARY OBJECTIVES: I. To estimate the frequency and severity of toxicities of OBI-3424 in this patient population. II. To estimate event-free survival (EFS), relapse-free survival (RFS) and overall survival (OS) in this patient population. TRANSLATIONAL MEDICINE OBJECTIVES: I. To estimate minimal/measurable residual disease (MRD) negativity (among patients who achieve CR or CRi). II. To assess AKR1C3 expression levels in this patient population. III. To evaluate associations between AKR1C3 expression and response to OBI-3424, achievement of MRD-negative remission, and relapse from remission. IV. To bank specimens for future research. OUTLINE: This is a phase I, dose-escalation study followed by a phase II study. Patients receive AKR1C3-activated prodrug OBI-3424 intravenously (IV) over 30 minutes on days 1 and 8. Treatment repeats every 21 days for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients who have not achieved a partial remission (PR) by the 4th cycle of treatment are removed from the study (unless clinically benefiting in the opinion of the treating investigator). Patients undergo blood sample collection during screening and cerebrospinal fluid (CSF) sample collection on study. Patients also undergo bone marrow aspirate or core biopsy and may undergo computed tomography (CT) scan throughout the study. After completion of study treatment, patients are followed up every month for 1 year, every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for up to 5 years from registration.
Eligibility Criteria
Age Range: 12 years to No maximum
Interventions
AKR1C3-activated Prodrug AST-3424
Biopsy Procedure
Biospecimen Collection
Bone Marrow Aspiration
Computed Tomography
Conditions
Locations
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United States
Kingman Regional Medical Center
Kingman, Arizona 86401
United States
Arkansas Children's Hospital
Little Rock, Arkansas 72202-3591
United States
PCR Oncology
Arroyo Grande, California 93420
United States
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United States
Loma Linda University Medical Center
Loma Linda, California 92354
United States
Children's Hospital of Orange County
Orange, California 92868
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Alfred I duPont Hospital for Children
Wilmington, Delaware 19803
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida 33908
United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida 33701
United States
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia 30322
United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia 30329
United States
Augusta University Medical Center
Augusta, Georgia 30912
United States
Loyola Center for Health at Burr Ridge
Burr Ridge, Illinois 60527
United States
Lurie Children's Hospital-Chicago
Chicago, Illinois 60611
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
Loyola Medicine Homer Glen
Homer Glen, Illinois 60491
United States
Northwestern Medicine Lake Forest Hospital
Lake Forest, Illinois 60045
United States
Loyola University Medical Center
Maywood, Illinois 60153
United States
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
Melrose Park, Illinois 60160
United States
UC Comprehensive Cancer Center at Silver Cross
New Lenox, Illinois 60451
United States
University of Chicago Medicine-Orland Park
Orland Park, Illinois 60462
United States
Southern Illinois University School of Medicine
Springfield, Illinois 62702
United States
Mary Greeley Medical Center
Ames, Iowa 50010
United States
McFarland Clinic - Ames
Ames, Iowa 50010
United States
McFarland Clinic - Boone
Boone, Iowa 50036
United States
McFarland Clinic - Trinity Cancer Center
Fort Dodge, Iowa 50501
United States
McFarland Clinic - Jefferson
Jefferson, Iowa 50129
United States
McFarland Clinic - Marshalltown
Marshalltown, Iowa 50158
United States
Norton Children's Hospital
Louisville, Kentucky 40202
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
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland 21287
United States
Bronson Battle Creek
Battle Creek, Michigan 49017
United States
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
United States
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
United States
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan 49503
United States
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
Grand Rapids, Michigan 49503
United States
Trinity Health Grand Rapids Hospital
Grand Rapids, Michigan 49503
United States
Bronson Methodist Hospital
Kalamazoo, Michigan 49007
United States
West Michigan Cancer Center
Kalamazoo, Michigan 49007
United States
Beacon Kalamazoo Cancer Center
Kalamazoo, Michigan 49009
United States
Beacon Kalamazoo
Kalamazoo, Michigan 49048
United States
Trinity Health Muskegon Hospital
Muskegon, Michigan 49444
United States
Corewell Health Lakeland Hospitals - Niles Hospital
Niles, Michigan 49120
United States
Cancer and Hematology Centers of Western Michigan - Norton Shores
Norton Shores, Michigan 49444
United States
Corewell Health Reed City Hospital
Reed City, Michigan 49677
United States
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
Saint Joseph, Michigan 49085
United States
Corewell Health Lakeland Hospitals - Saint Joseph Hospital
Saint Joseph, Michigan 49085
United States
Munson Medical Center
Traverse City, Michigan 49684
United States
University of Michigan Health - West
Wyoming, Michigan 49519
United States
Fairview Ridges Hospital
Burnsville, Minnesota 55337
United States
Minnesota Oncology - Burnsville
Burnsville, Minnesota 55337
United States
Cambridge Medical Center
Cambridge, Minnesota 55008
United States
Mercy Hospital
Coon Rapids, Minnesota 55433
United States
Fairview Southdale Hospital
Edina, Minnesota 55435
United States
Unity Hospital
Fridley, Minnesota 55432
United States
Fairview Clinics and Surgery Center Maple Grove
Maple Grove, Minnesota 55369
United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood, Minnesota 55109
United States
Saint John's Hospital - Healtheast
Maplewood, Minnesota 55109
United States
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
United States
Hennepin County Medical Center
Minneapolis, Minnesota 55415
United States
Health Partners Inc
Minneapolis, Minnesota 55454
United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
United States
Monticello Cancer Center
Monticello, Minnesota 55362
United States
New Ulm Medical Center
New Ulm, Minnesota 56073
United States
Fairview Northland Medical Center
Princeton, Minnesota 55371
United States
North Memorial Medical Health Center
Robbinsdale, Minnesota 55422
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
Saint Francis Regional Medical Center
Shakopee, Minnesota 55379
United States
Lakeview Hospital
Stillwater, Minnesota 55082
United States
Ridgeview Medical Center
Waconia, Minnesota 55387
United States
Rice Memorial Hospital
Willmar, Minnesota 56201
United States
Minnesota Oncology Hematology PA-Woodbury
Woodbury, Minnesota 55125
United States
Fairview Lakes Medical Center
Wyoming, Minnesota 55092
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108
United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska 68114
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
Carson Tahoe Regional Medical Center
Carson City, Nevada 89703
United States
Cancer and Blood Specialists-Henderson
Henderson, Nevada 89052
United States
Comprehensive Cancer Centers of Nevada - Henderson
Henderson, Nevada 89052
United States
Comprehensive Cancer Centers of Nevada-Horizon Ridge
Henderson, Nevada 89052
United States
Las Vegas Cancer Center-Henderson
Henderson, Nevada 89052
United States
OptumCare Cancer Care at Seven Hills
Henderson, Nevada 89052
United States
Comprehensive Cancer Centers of Nevada-Southeast Henderson
Henderson, Nevada 89074
United States
GenesisCare USA - Henderson
Henderson, Nevada 89074
United States
Las Vegas Urology - Green Valley
Henderson, Nevada 89074
United States
Las Vegas Urology - Pebble
Henderson, Nevada 89074
United States
Urology Specialists of Nevada - Green Valley
Henderson, Nevada 89074
United States
Las Vegas Urology - Pecos
Las Vegas, Nevada 89074
United States
Desert West Surgery
Las Vegas, Nevada 89102
United States
OptumCare Cancer Care at Charleston
Las Vegas, Nevada 89102
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
United States
Hope Cancer Care of Nevada
Las Vegas, Nevada 89103
United States
Radiation Oncology Centers of Nevada Central
Las Vegas, Nevada 89106
United States
Urology Specialists of Nevada - Central
Las Vegas, Nevada 89106
United States
GenesisCare USA - Las Vegas
Las Vegas, Nevada 89109
United States
HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
Las Vegas, Nevada 89109
United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada 89109
United States
HealthCare Partners Medical Group Oncology/Hematology-San Martin
Las Vegas, Nevada 89113
United States
Las Vegas Prostate Cancer Center
Las Vegas, Nevada 89113
United States
Las Vegas Urology - Sunset
Las Vegas, Nevada 89113
United States
Urology Specialists of Nevada - Southwest
Las Vegas, Nevada 89113
United States
Radiation Oncology Centers of Nevada Southeast
Las Vegas, Nevada 89119
United States
Ann M Wierman MD LTD
Las Vegas, Nevada 89128
United States
Comprehensive Cancer Centers of Nevada - Northwest
Las Vegas, Nevada 89128
United States
GenesisCare USA - Vegas Tenaya
Las Vegas, Nevada 89128
United States
HealthCare Partners Medical Group Oncology/Hematology-Tenaya
Las Vegas, Nevada 89128
United States
Las Vegas Urology - Cathedral Rock
Las Vegas, Nevada 89128
United States
Las Vegas Urology - Smoke Ranch
Las Vegas, Nevada 89128
United States
OptumCare Cancer Care at MountainView
Las Vegas, Nevada 89128
United States
Urology Specialists of Nevada - Northwest
Las Vegas, Nevada 89128
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
United States
Comprehensive Cancer Centers of Nevada - Town Center
Las Vegas, Nevada 89144
United States
Comprehensive Cancer Centers of Nevada-Summerlin
Las Vegas, Nevada 89144
United States
Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
United States
Las Vegas Cancer Center-Medical Center
Las Vegas, Nevada 89148-2405
United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada 89148
United States
GenesisCare USA - Fort Apache
Las Vegas, Nevada 89148
United States
OptumCare Cancer Care at Fort Apache
Las Vegas, Nevada 89148
United States
HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
Las Vegas, Nevada 89149
United States
Comprehensive Cancer Centers of Nevada - Central Valley
Las Vegas, Nevada 89169
United States
University Cancer Center
Las Vegas, Nevada 89169
United States
Hope Cancer Care of Nevada-Pahrump
Pahrump, Nevada 89048
United States
Renown Regional Medical Center
Reno, Nevada 89502
United States
Saint Mary's Regional Medical Center
Reno, Nevada 89503
United States
Radiation Oncology Associates
Reno, Nevada 89509
United States
University of New Mexico Cancer Center
Albuquerque, New Mexico 87106
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
University of Rochester
Rochester, New York 14642
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania 15224
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Prisma Health Richland Hospital
Columbia, South Carolina 29203
United States
The Children's Hospital at TriStar Centennial
Nashville, Tennessee 37203
United States
Dell Children's Medical Center of Central Texas
Austin, Texas 78723
United States
El Paso Children's Hospital
El Paso, Texas 79905
United States
Methodist Children's Hospital of South Texas
San Antonio, Texas 78229
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah 84112
United States
University of Virginia Cancer Center
Charlottesville, Virginia 22908
United States
Children's Hospital of The King's Daughters
Norfolk, Virginia 23507
United States
VCU Massey Comprehensive Cancer Center
Richmond, Virginia 23298
United States
Overlake Medical Center
Bellevue, Washington 98004
United States
Valley Medical Center
Renton, Washington 98055
United States
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United States
University of Washington Medical Center - Montlake
Seattle, Washington 98195
United States
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
Yakima, Washington 98902
United States
West Virginia University Healthcare
Morgantown, West Virginia 26506
United States
Gundersen Lutheran Medical Center
La Crosse, Wisconsin 54601
United States
Cancer Center of Western Wisconsin
New Richmond, Wisconsin 54017
United States