Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or T-Cell Lymphoblastic Lymphoma (T-LBL)

August 11, 2025 updated by: SWOG Cancer Research Network

A Phase I/II Study of AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) In Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)/T-Cell Lymphoblastic Lymphoma (T-LBL)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

67

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Active, not recruiting
        • University of Alabama at Birmingham Cancer Center
    • Arizona
      • Kingman, Arizona, United States, 86401
        • Recruiting
        • Kingman Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • Arkansas
      • Little Rock, Arkansas, United States, 72202-3591
        • Recruiting
        • Arkansas Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 501-364-7373
        • Principal Investigator:
          • David L. Becton
    • California
      • Arroyo Grande, California, United States, 93420
        • Recruiting
        • PCR Oncology
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Ibrahim Aldoss
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 909-558-4050
        • Principal Investigator:
          • Albert Kheradpour
      • Orange, California, United States, 92868
        • Recruiting
        • Children's Hospital of Orange County
        • Contact:
        • Principal Investigator:
          • Elyssa M. Rubin
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • Children's Hospital Colorado
        • Principal Investigator:
          • Kelly E. Faulk
        • Contact:
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • Recruiting
        • Alfred I duPont Hospital for Children
        • Contact:
        • Principal Investigator:
          • Emi H. Caywood
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Recruiting
        • Golisano Children's Hospital of Southwest Florida
        • Contact:
        • Principal Investigator:
          • Emad K. Salman
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 954-265-1847
          • Email: OHR@mhs.net
        • Principal Investigator:
          • Iftikhar Hanif
      • Saint Petersburg, Florida, United States, 33701
        • Recruiting
        • Johns Hopkins All Children's Hospital
        • Contact:
        • Principal Investigator:
          • Jennifer B. Dean
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Nikolaos Papadantonakis
      • Atlanta, Georgia, United States, 30329
        • Recruiting
        • Children's Healthcare of Atlanta - Arthur M Blank Hospital
        • Principal Investigator:
          • Ryan J. Summers
        • Contact:
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Medical Center
        • Contact:
        • Principal Investigator:
          • Colleen H. McDonough
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Active, not recruiting
        • Loyola Center for Health at Burr Ridge
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Lurie Children's Hospital-Chicago
        • Contact:
          • Site Public Contact
          • Phone Number: 773-880-4562
        • Principal Investigator:
          • Jenna Rossoff
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Principal Investigator:
          • Shira N. Dinner
        • Contact:
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • University of Illinois
        • Contact:
          • Site Public Contact
          • Phone Number: 312-355-3046
        • Principal Investigator:
          • John G. Quigley
      • Chicago, Illinois, United States, 60637
        • Active, not recruiting
        • University of Chicago Comprehensive Cancer Center
      • Homer Glen, Illinois, United States, 60491
        • Active, not recruiting
        • Loyola Medicine Homer Glen
      • Lake Forest, Illinois, United States, 60045
        • Active, not recruiting
        • Northwestern Medicine Lake Forest Hospital
      • Maywood, Illinois, United States, 60153
        • Active, not recruiting
        • Loyola University Medical Center
      • Melrose Park, Illinois, United States, 60160
        • Active, not recruiting
        • Marjorie Weinberg Cancer Center at Loyola-Gottlieb
      • New Lenox, Illinois, United States, 60451
        • Active, not recruiting
        • UC Comprehensive Cancer Center at Silver Cross
      • Orland Park, Illinois, United States, 60462
        • Active, not recruiting
        • University of Chicago Medicine-Orland Park
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Southern Illinois University School of Medicine
        • Contact:
          • Site Public Contact
          • Phone Number: 217-545-7929
        • Principal Investigator:
          • Gregory P. Brandt
    • Iowa
      • Ames, Iowa, United States, 50010
        • Recruiting
        • Mary Greeley Medical Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Ames, Iowa, United States, 50010
        • Recruiting
        • McFarland Clinic - Ames
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
      • Boone, Iowa, United States, 50036
        • Recruiting
        • McFarland Clinic - Boone
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Fort Dodge, Iowa, United States, 50501
        • Recruiting
        • McFarland Clinic - Trinity Cancer Center
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Jefferson, Iowa, United States, 50129
        • Recruiting
        • McFarland Clinic - Jefferson
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
      • Marshalltown, Iowa, United States, 50158
        • Recruiting
        • McFarland Clinic - Marshalltown
        • Principal Investigator:
          • Joseph J. Merchant
        • Contact:
          • Site Public Contact
          • Phone Number: 515-956-4132
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Recruiting
        • Norton Children's Hospital
        • Contact:
        • Principal Investigator:
          • Michael J. Ferguson
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70805
        • Recruiting
        • LSU Health Baton Rouge-North Clinic
        • Contact:
        • Principal Investigator:
          • Nakhle S. Saba
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of the Lake Physician Group
        • Contact:
        • Principal Investigator:
          • Nakhle S. Saba
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins University/Sidney Kimmel Cancer Center
        • Principal Investigator:
          • Stacy L. Cooper
        • Contact:
    • Michigan
      • Battle Creek, Michigan, United States, 49017
        • Recruiting
        • Bronson Battle Creek
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Detroit, Michigan, United States, 48201
        • Active, not recruiting
        • Wayne State University/Karmanos Cancer Institute
      • Farmington Hills, Michigan, United States, 48334
        • Active, not recruiting
        • Weisberg Cancer Treatment Center
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Trinity Health Grand Rapids Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Grand Rapids Hospitals - Butterworth Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Grand Rapids, Michigan, United States, 49503
        • Recruiting
        • Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • Bronson Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Kalamazoo, Michigan, United States, 49009
        • Recruiting
        • Beacon Kalamazoo Cancer Center
        • Principal Investigator:
          • Kathleen Y. Butler
        • Contact:
          • Site Public Contact
          • Phone Number: 574-647-7370
      • Kalamazoo, Michigan, United States, 49048
        • Recruiting
        • Beacon Kalamazoo
        • Principal Investigator:
          • Kathleen Y. Butler
        • Contact:
          • Site Public Contact
          • Phone Number: 574-647-7370
      • Muskegon, Michigan, United States, 49444
        • Recruiting
        • Trinity Health Muskegon Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Niles, Michigan, United States, 49120
        • Recruiting
        • Corewell Health Lakeland Hospitals - Niles Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 616-391-1230
        • Principal Investigator:
          • Kathleen Y. Butler
      • Norton Shores, Michigan, United States, 49444
        • Recruiting
        • Cancer and Hematology Centers of Western Michigan - Norton Shores
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Reed City, Michigan, United States, 49677
        • Recruiting
        • Corewell Health Reed City Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Saint Joseph, Michigan, United States, 49085
        • Recruiting
        • Corewell Health Lakeland Hospitals - Saint Joseph Hospital
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Traverse City, Michigan, United States, 49684
        • Recruiting
        • Munson Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • University of Michigan Health - West
        • Contact:
        • Principal Investigator:
          • Kathleen Y. Butler
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Active, not recruiting
        • Minnesota Oncology - Burnsville
      • Burnsville, Minnesota, United States, 55337
        • Active, not recruiting
        • Fairview Ridges Hospital
      • Cambridge, Minnesota, United States, 55008
        • Active, not recruiting
        • Cambridge Medical Center
      • Coon Rapids, Minnesota, United States, 55433
        • Active, not recruiting
        • Mercy Hospital
      • Edina, Minnesota, United States, 55435
        • Active, not recruiting
        • Fairview Southdale Hospital
      • Fridley, Minnesota, United States, 55432
        • Active, not recruiting
        • Unity Hospital
      • Maple Grove, Minnesota, United States, 55369
        • Active, not recruiting
        • Fairview Clinics and Surgery Center Maple Grove
      • Maplewood, Minnesota, United States, 55109
        • Active, not recruiting
        • Minnesota Oncology Hematology PA-Maplewood
      • Maplewood, Minnesota, United States, 55109
        • Active, not recruiting
        • Saint John's Hospital - Healtheast
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota/Masonic Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 612-624-2620
        • Principal Investigator:
          • Peter M. Gordon
      • Minneapolis, Minnesota, United States, 55454
        • Active, not recruiting
        • Health Partners Inc
      • Minneapolis, Minnesota, United States, 55415
        • Active, not recruiting
        • Hennepin County Medical Center
      • Minneapolis, Minnesota, United States, 55407
        • Active, not recruiting
        • Abbott-Northwestern Hospital
      • Monticello, Minnesota, United States, 55362
        • Active, not recruiting
        • Monticello Cancer Center
      • New Ulm, Minnesota, United States, 56073
        • Active, not recruiting
        • New Ulm Medical Center
      • Princeton, Minnesota, United States, 55371
        • Active, not recruiting
        • Fairview Northland Medical Center
      • Robbinsdale, Minnesota, United States, 55422
        • Active, not recruiting
        • North Memorial Medical Health Center
      • Saint Louis Park, Minnesota, United States, 55416
        • Active, not recruiting
        • Park Nicollet Clinic - Saint Louis Park
      • Saint Paul, Minnesota, United States, 55101
        • Active, not recruiting
        • Regions Hospital
      • Saint Paul, Minnesota, United States, 55102
        • Active, not recruiting
        • United Hospital
      • Shakopee, Minnesota, United States, 55379
        • Active, not recruiting
        • Saint Francis Regional Medical Center
      • Stillwater, Minnesota, United States, 55082
        • Active, not recruiting
        • Lakeview Hospital
      • Waconia, Minnesota, United States, 55387
        • Active, not recruiting
        • Ridgeview Medical Center
      • Willmar, Minnesota, United States, 56201
        • Active, not recruiting
        • Rice Memorial Hospital
      • Woodbury, Minnesota, United States, 55125
        • Active, not recruiting
        • Minnesota Oncology Hematology PA-Woodbury
      • Wyoming, Minnesota, United States, 55092
        • Active, not recruiting
        • Fairview Lakes Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Hospitals and Clinics
        • Contact:
          • Site Public Contact
          • Phone Number: 816-302-6808
          • Email: rryan@cmh.edu
        • Principal Investigator:
          • Kevin F. Ginn
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Children's Hospital and Medical Center of Omaha
        • Contact:
          • Site Public Contact
          • Phone Number: 402-955-3949
        • Principal Investigator:
          • Jill C. Beck
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • University of Nebraska Medical Center
        • Contact:
        • Principal Investigator:
          • Jill C. Beck
    • Nevada
      • Carson City, Nevada, United States, 89703
        • Recruiting
        • Carson Tahoe Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Cancer and Blood Specialists-Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Horizon Ridge
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89052
        • Recruiting
        • OptumCare Cancer Care at Seven Hills
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Southeast Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • GenesisCare USA - Henderson
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Green Valley
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Pebble
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89074
        • Recruiting
        • Urology Specialists of Nevada - Green Valley
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Henderson, Nevada, United States, 89052
        • Suspended
        • Las Vegas Cancer Center-Henderson
      • Las Vegas, Nevada, United States, 89074
        • Recruiting
        • Las Vegas Urology - Pecos
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89102
        • Suspended
        • Desert West Surgery
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • OptumCare Cancer Care at Charleston
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89102
        • Recruiting
        • University Medical Center of Southern Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89103
        • Recruiting
        • Hope Cancer Care of Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Radiation Oncology Centers of Nevada Central
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89106
        • Recruiting
        • Urology Specialists of Nevada - Central
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • GenesisCare USA - Las Vegas
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89109
        • Suspended
        • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway
      • Las Vegas, Nevada, United States, 89109
        • Recruiting
        • Sunrise Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89113
        • Suspended
        • HealthCare Partners Medical Group Oncology/Hematology-San Martin
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Las Vegas Prostate Cancer Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Las Vegas Urology - Sunset
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Urology Specialists of Nevada - Southwest
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89119
        • Recruiting
        • Radiation Oncology Centers of Nevada Southeast
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Ann M Wierman MD LTD
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Northwest
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • GenesisCare USA - Vegas Tenaya
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Suspended
        • HealthCare Partners Medical Group Oncology/Hematology-Tenaya
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Las Vegas Urology - Cathedral Rock
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Las Vegas Urology - Smoke Ranch
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • OptumCare Cancer Care at MountainView
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89128
        • Recruiting
        • Urology Specialists of Nevada - Northwest
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Las Vegas, Nevada, United States, 89135
        • Recruiting
        • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Town Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Comprehensive Cancer Centers of Nevada-Summerlin
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89144
        • Recruiting
        • Summerlin Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Comprehensive Cancer Centers of Nevada
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • GenesisCare USA - Fort Apache
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • OptumCare Cancer Care at Fort Apache
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89149
        • Suspended
        • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • Comprehensive Cancer Centers of Nevada - Central Valley
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89169
        • Recruiting
        • University Cancer Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Las Vegas, Nevada, United States, 89148-2405
        • Suspended
        • Las Vegas Cancer Center-Medical Center
      • Pahrump, Nevada, United States, 89048
        • Recruiting
        • Hope Cancer Care of Nevada-Pahrump
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89503
        • Recruiting
        • Saint Mary's Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
      • Reno, Nevada, United States, 89509
        • Recruiting
        • Radiation Oncology Associates
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Recruiting
        • University of New Mexico Cancer Center
        • Contact:
        • Principal Investigator:
          • Charles Foucar
    • New York
      • Buffalo, New York, United States, 14263
        • Active, not recruiting
        • Roswell Park Cancer Institute
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
          • Site Public Contact
          • Phone Number: 585-275-5830
        • Principal Investigator:
          • Paul M. Barr
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Harry P. Erba
        • Contact:
          • Site Public Contact
          • Phone Number: 888-275-3853
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Erin H. Breese
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati Cancer Center-UC Medical Center
        • Principal Investigator:
          • Emily K. Curran
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Anjali S. Advani
      • West Chester, Ohio, United States, 45069
        • Suspended
        • University of Cincinnati Cancer Center-West Chester
    • Oregon
      • Portland, Oregon, United States, 97239
        • Active, not recruiting
        • Oregon Health and Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Susan R. Rheingold
      • Pittsburgh, Pennsylvania, United States, 15224
        • Recruiting
        • Children's Hospital of Pittsburgh of UPMC
        • Contact:
        • Principal Investigator:
          • Colleen Mathews
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Principal Investigator:
          • Bradley DeNardo
        • Contact:
          • Site Public Contact
          • Phone Number: 401-444-1488
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Recruiting
        • Prisma Health Richland Hospital
        • Principal Investigator:
          • Stuart L. Cramer
        • Contact:
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • The Children's Hospital at TriStar Centennial
        • Contact:
          • Site Public Contact
          • Phone Number: 615-342-1919
        • Principal Investigator:
          • Clinton M. Carroll
    • Texas
      • Austin, Texas, United States, 78723
        • Recruiting
        • Dell Children's Medical Center of Central Texas
        • Contact:
        • Principal Investigator:
          • Shannon M. Cohn
      • El Paso, Texas, United States, 79905
        • Recruiting
        • El Paso Children's Hospital
        • Contact:
        • Principal Investigator:
          • Benjamin Carcamo
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • University of Texas Health Science Center at San Antonio
        • Contact:
        • Principal Investigator:
          • Anne-Marie R. Langevin
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Methodist Children's Hospital of South Texas
        • Contact:
        • Principal Investigator:
          • Jose M. Esquilin
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Paul J. Shami
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Norfolk, Virginia, United States, 23507
        • Recruiting
        • Children's Hospital of The King's Daughters
        • Contact:
        • Principal Investigator:
          • Melissa S. Mark
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • VCU Massey Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Thuy Ho
    • Washington
      • Bellevue, Washington, United States, 98004
        • Suspended
        • Overlake Medical Center
      • Renton, Washington, United States, 98055
        • Recruiting
        • Valley Medical Center
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
      • Seattle, Washington, United States, 98195
        • Recruiting
        • University of Washington Medical Center - Montlake
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Ryan D. Cassaday
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Ryan D. Cassaday
      • Yakima, Washington, United States, 98902
        • Recruiting
        • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
        • Principal Investigator:
          • John A. Ellerton
        • Contact:
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University Healthcare
        • Contact:
        • Principal Investigator:
          • Lauren W. Veltri
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Active, not recruiting
        • Gundersen Lutheran Medical Center
      • New Richmond, Wisconsin, United States, 54017
        • Active, not recruiting
        • Cancer Center of Western Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients must have a diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia (T-ALL) based on World Health Organization (WHO) classification. Patients with relapsed/refractory T-cell lymphoblastic lymphoma are eligible if lymphoblasts are >= 5% in the bone marrow or in the peripheral blood by morphology or flow cytometry
  • Patients must have evidence of acute leukemia in their peripheral blood or bone marrow. Patients must have >= 5% lymphoblasts in the peripheral blood or bone marrow within 14 days prior to registration. Patients with only extramedullary disease are not eligible

  • Patients ≥ 18 years of age must be refractory to or have relapsed following a standard induction chemotherapy. Patients < 18 years of age must have relapsed or must be refractory after 2 or more chemotherapy cycles (example: induction and consolidation)

    • A standard chemotherapy induction regimen is defined as any program of treatment that includes:

      • Vincristine and corticosteroids plus at least one more chemotherapy agent
      • Cytarabine and anthracycline, or
      • High dose cytarabine (defined as at least 1 gr/m^2 per individual dose unless adjustments were required for renal/liver function)
  • Patients must have no evidence of central nervous system disease within 28 days prior to registration based on cerebrospinal fluid (CSF) studies. Patients with clinical signs or symptoms consistent with central nervous system (CNS) involvement must have a lumbar puncture which is negative for CNS involvement; the lumbar puncture must be completed within 28 days prior to registration. Patients with CNS1 or CNS2 are eligible; however patients with CNS3 are not eligible
  • Note that the patients may receive intrathecal chemotherapy with the initial lumbar puncture. This may count as the first dose of intrathecal therapy required as part of the study
  • Prior nelarabine therapy is not required. In addition, for patients ≥ 18 years of age who received nelarabine during initial induction or post-remission treatment are eligible only if the physician does not feel they would benefit from other, multi-agent chemotherapy
  • Patients must not have had chemotherapy or investigational agents within 14 days prior to registration except for corticosteroids, oral 6-mercaptopurine, oral methotrexate, vincristine, intrathecal chemotherapy, or hydroxyurea. For participants who have received radiation therapy, at least 7 days must have elapsed from the end of radiation prior to registration and participants must not currently be experiencing toxicities from radiation therapy
  • Patients must not have undergone allogeneic hematopoietic transplant within 90 days prior to registration
  • Patients must have no evidence of active >= grade 2 acute graft versus host disease (GVHD) or moderate or severe limited chronic GVHD. Patients must have no history of extensive GVHD of any severity within 90 days prior to registration. Patients who are post-transplant must be off calcineurin inhibitors for at least 21 days to be eligible. Extensive GVHD is defined as 1) generalized skin involvement or 2) localized skin involvement and/or hepatic dysfunction plus liver histology or cirrhosis or involvement of eye or minor salivary organ or oral mucosa or any other target organ
  • Patients must be >= 12 years of age
  • Patients ≥ 16 years of age must have a Zubrod Performance Status of 0-3. Patients < 16 years of age must have a Lansky score of ≥ 50
  • Patients must not have systemic fungal, bacterial, viral or other infection that is not controlled (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment) within 14 days prior to registration
  • Patients ≥ 18 years of age must have creatinine clearance > 30 mL/min within 14 days prior to registration according to the Cockcroft Gault equation
  • Patients 12-17 years of age must have adequate renal function within 14 days prior to registration defined as serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) according to age or a calculated estimated glomerular filtration rate (eGFR) (based on Schwartz formula) or radioisotope glomerular filtration rate (GFR) ≥ 50ml/min/1.73 m^2
  • Patients must have direct bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 14 days prior to registration
  • Patients must have alanine aminotransferase (ALT) =< 3.0 x institutional upper limit of normal (ULN) or =< 5.0 x ULN (if thought to be related to leukemic involvement) within 14 days prior to registration
  • Prothrombin time (PT)/partial thromboplastin time (PTT)/ fibrinogen (as clinically indicated for example but not limited to history of bleeding or active bleeding, concern for disseminated intravascular coagulation) (within 14 days prior to registration to obtain baseline measurements)
  • From metabolic panel (comprehensive or basic): sodium, potassium, chloride, carbon dioxide (CO2), and blood urea nitrogen (BUN) (within 14 days prior to registration to obtain baseline measurements)
  • Patients must be able to safely discontinue use of strong inhibitors/inducers of CYP3A4 or PgP-g-p and must be able to safely discontinue use of naproxen for 48 hours before and after each dose of OBI-3424
  • Patients with known human immunodeficiency virus (HIV)-infection are eligible providing they are on effective anti-retroviral therapy and have undetectable viral load at their most recent viral load test within 6 months prior to registration. (HIV viral load testing is required only for patients with known HIV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4
  • Patients with evidence of chronic hepatitis B virus (HBV) infection may be eligible provided that they have an undetectable HBV viral load within 28 days prior to registration. Patients may be currently receiving HBV treatment. (HBV viral load testing is required only for patients with known HBV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4
  • Patients with known history of hepatitis C virus (HCV) infection may be eligible provided that they have an undetectable HCV viral load within in 28 days prior to registration. Patients may be currently receiving treatment. (HCV viral load testing is required only for patients with known HCV infection). Patients must not be receiving antiviral therapies that are known strong inhibitors or inducers of CYP3A4
  • Patients must not have a known history of prolonged QT interval by Fridericia (QTcF) (interval > 450 msec for males; > 470 msec for females). Patients that had transient prolongation of QTc secondary to medications or electrolyte abnormalities are not excluded if the QTc normalized and remain within acceptable QTcF range (interval > 450 msec for males; > 470 msec for females). Additionally, suspected medications should be no longer required or used, and electrolyte abnormalities must have normalized
  • Patients must not be pregnant or nursing due to the teratogenic potential of the drug used on this study. Females of reproductive potential must have a negative serum pregnancy test within 14 days prior to registration. Women/men of reproductive potential must have agreed to use an effective contraceptive method during and up to 6 months after treatment. A woman is considered to be of "reproductive potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures
  • Patients must not have other active malignancies for which they have received treatments within 6 months prior to registration excluding localized malignancies that do not require systemic treatment
  • Patients must agree to have bone marrow and blood specimens submitted for MRD testing
  • Patients must be offered the opportunity to participate in specimen banking. With patient consent, residuals from specimens submitted will be retained and banked for future research
  • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with fedral, local, institutional and Central Institutional Review Board (CIRB) guidelines unless they are unable to provide consent based on age (< 18 years) or based on impaired decision-making capabilities. For patients < 18 years of age or with impaired decision making capabilities, parents or other legally authorized representatives must sign and give informed consent on behalf of study participants in accordance with applicable federal, local, institutional and CIRB regulations
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system
  • This trial will use a slot reservation system to enroll the Phase I portion of the study. Patients planning to enroll at this phase of the study must first have a slot reserved in advance of the registration. All site staff will use OPEN to create a slot reservation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (AKR1C3-activated prodrug OBI-3424)
Patients receive AKR1C3-activated prodrug OBI-3424 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 PR by the 4th cycle of treatment are removed from the study (unless clinically benefitting in the opinion of the treating investigator).Patients undergo blood sample collection during screening and CSF sample collection on study. Patients also undergo bone marrow aspirate or core biopsy and may undergo CT scan throughout the study.
Procedure: Computed Tomography
Undergo CT scan
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
  • Computerized axial tomography (procedure)
  • Computerized Tomography (CT) scan
Procedure: Bone Marrow Aspiration
Undergo bone marrow aspirate
Procedure: Biospecimen Collection
Undergo blood and CSF sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Biopsy Procedure
Undergo biopsy
Other Names:
  • Bx
  • BIOPSY_TYPE
  • Biopsy
Drug: AKR1C3-activated Prodrug AST-3424
Given IV
Other Names:
  • AKR1C3-activated Prodrug TH-3424
  • Aldo-keto Reductase 1c3-activated Prodrug OBI-3424
  • OBI 3424
  • OBI-3424
  • OBI3424
  • TH 3424
  • TH-3424
  • TH3424
  • AKR1C3-activated Prodrug OBI-3424
  • AST-3424

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum tolerated dose (MTD) (Phase I)
Time Frame: Up to 21 days
The regimen will be considered safe and the MTD determined if the dose-limiting toxicity rate is < 33%.
Up to 21 days
Response rate (complete remission [CR] or CR with incomplete count recovery [CRi]) (Phase II)
Time Frame: Up to 5 years
Up to 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to the time of relapse, assessed up to 5 years
Toxicities will be captured and described. The probability of any particular toxicity can be estimated to within at most +/- 17% (95% confidence interval).
Up to the time of relapse, assessed up to 5 years
Overall survival
Time Frame: From the day of registration on study until death from any cause with observations censored on the day of last contact for patients not known to have died, assessed up to 5 years
Will be estimated using the Kaplan-Meier method.
From the day of registration on study until death from any cause with observations censored on the day of last contact for patients not known to have died, assessed up to 5 years
Event-free survival
Time Frame: From the date of initial registration on study until the first of the following events: death from any cause, relapse from remission (CR or CRi) or completion of protocol therapy without documentation of CR or CRi, assessed up to 5 years
Will be estimated using the Kaplan-Meier method.
From the date of initial registration on study until the first of the following events: death from any cause, relapse from remission (CR or CRi) or completion of protocol therapy without documentation of CR or CRi, assessed up to 5 years
Relapse-free survival
Time Frame: From the date the patient first achieves CR or CRi until relapse from CR/CRi or death from any cause, assessed up to 5 years
Will be estimated using the Kaplan-Meier method.
From the date the patient first achieves CR or CRi until relapse from CR/CRi or death from any cause, assessed up to 5 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Minimal residual disease (MRD) rate
Time Frame: Up to 5 years
The MRD rate for responders will be reported as a point estimate with an exact binomial confidence interval.
Up to 5 years
AKR1C3 expression
Time Frame: Up to 5 years
A post-hoc analysis of AKR1C3 expression is planned.
Up to 5 years
Association between AKR1C3 and MRD-negative remission (CR or CRi) status
Time Frame: Up to 5 years
Will analyze all patients treated at the MTD.
Up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Anjali S Advani, SWOG Cancer Research Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 8, 2021

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

March 18, 2020

First Submitted That Met QC Criteria

March 18, 2020

First Posted (Actual)

March 19, 2020

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 11, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S1905 (Other Identifier: CTEP)
  • U10CA180888 (U.S. NIH Grant/Contract)
  • NCI-2020-00768 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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