Study to Test AKR1C3-Activated Prodrug OBI-3424 (OBI-3424) in Patients With Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia (T-ALL)

February 7, 2024 updated by: SWOG Cancer Research Network

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

This phase II trial studies how well OBI-3424 works in treating patients with T-cell acute lymphoblastic leukemia that has come back (relapsed) or does not response to treatment (refractory). Drugs used in chemotherapy, 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 OBJECTIVE:

I. To assess the response rate (complete remission [CR] or CR with incomplete count recovery [CRi]) of AKR1C3-activated prodrug OBI-3424 (OBI-3424) in patients with relapsed/refractory T-cell acute lymphoblastic leukemia (T-ALL).

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. c. To evaluate associations between AKR1C3 expression and response to OBI-3423, achievement of MRD-negative remission, and relapse from remission.

IV. To bank specimens for future research.

OUTLINE:

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.

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)

39

Phase

  • Phase 2

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
        • Recruiting
        • University of Alabama at Birmingham Cancer Center
        • Contact:
        • Principal Investigator:
          • Sravanti Rangaraju
    • Arizona
      • Kingman, Arizona, United States, 86401
        • Recruiting
        • Kingman Regional Medical Center
        • Contact:
        • Principal Investigator:
          • John A. Ellerton
    • 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
    • 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
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Active, not recruiting
        • Loyola Center for Health at Burr Ridge
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Comprehensive Cancer Center
        • Principal Investigator:
          • Adam DuVall
        • Contact:
      • 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
      • 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
        • Recruiting
        • UC Comprehensive Cancer Center at Silver Cross
        • Principal Investigator:
          • Adam DuVall
        • Contact:
      • Orland Park, Illinois, United States, 60462
        • Recruiting
        • University of Chicago Medicine-Orland Park
        • Principal Investigator:
          • Adam DuVall
        • Contact:
    • 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
    • Michigan
      • 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
    • Minnesota
      • Burnsville, Minnesota, United States, 55337
        • Recruiting
        • Minnesota Oncology - Burnsville
        • Contact:
        • Principal Investigator:
          • David M. King
      • Burnsville, Minnesota, United States, 55337
        • Suspended
        • Fairview Ridges Hospital
      • Cambridge, Minnesota, United States, 55008
        • Recruiting
        • Cambridge Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Coon Rapids, Minnesota, United States, 55433
        • Recruiting
        • Mercy Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Edina, Minnesota, United States, 55435
        • Recruiting
        • Fairview Southdale Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Fridley, Minnesota, United States, 55432
        • Active, not recruiting
        • Unity Hospital
      • Maple Grove, Minnesota, United States, 55369
        • Recruiting
        • Fairview Clinics and Surgery Center Maple Grove
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Minnesota Oncology Hematology PA-Maplewood
        • Contact:
        • Principal Investigator:
          • David M. King
      • Maplewood, Minnesota, United States, 55109
        • Recruiting
        • Saint John's Hospital - Healtheast
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Abbott-Northwestern Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55415
        • Recruiting
        • Hennepin County Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Minneapolis, Minnesota, United States, 55454
        • Recruiting
        • Health Partners Inc
        • Contact:
        • Principal Investigator:
          • David M. King
      • Monticello, Minnesota, United States, 55362
        • Recruiting
        • Monticello Cancer Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • New Ulm, Minnesota, United States, 56073
        • Recruiting
        • New Ulm Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Princeton, Minnesota, United States, 55371
        • Recruiting
        • Fairview Northland Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Robbinsdale, Minnesota, United States, 55422
        • Recruiting
        • North Memorial Medical Health Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Louis Park, Minnesota, United States, 55416
        • Recruiting
        • Park Nicollet Clinic - Saint Louis Park
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55101
        • Recruiting
        • Regions Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Saint Paul, Minnesota, United States, 55102
        • Recruiting
        • United Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Shakopee, Minnesota, United States, 55379
        • Recruiting
        • Saint Francis Regional Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Stillwater, Minnesota, United States, 55082
        • Recruiting
        • Lakeview Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Waconia, Minnesota, United States, 55387
        • Recruiting
        • Ridgeview Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
      • Willmar, Minnesota, United States, 56201
        • Recruiting
        • Rice Memorial Hospital
        • Contact:
        • Principal Investigator:
          • David M. King
      • Woodbury, Minnesota, United States, 55125
        • Recruiting
        • Minnesota Oncology Hematology PA-Woodbury
        • Contact:
        • Principal Investigator:
          • David M. King
      • Wyoming, Minnesota, United States, 55092
        • Recruiting
        • Fairview Lakes Medical Center
        • Contact:
        • Principal Investigator:
          • David M. King
    • 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, 87102
        • 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, 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
        • Recruiting
        • Oregon Health and Science University
        • Principal Investigator:
          • Jessica T. Leonard
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Contact:
        • Principal Investigator:
          • Paul J. Shami
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Principal Investigator:
          • Keri R. Maher
        • Contact:
    • 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, 98109
        • Recruiting
        • FHCC South Lake Union
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Ryan D. Cassaday
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutchinson Cancer Research Center
        • Contact:
          • Site Public Contact
          • Phone Number: 800-804-8824
        • Principal Investigator:
          • Ryan D. Cassaday
      • 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
      • 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
        • Recruiting
        • Gundersen Lutheran Medical Center
        • Contact:
        • Principal Investigator:
          • David E. Marinier
      • New Richmond, Wisconsin, United States, 54017
        • Recruiting
        • Cancer Center of Western Wisconsin
        • Contact:
        • Principal Investigator:
          • David M. King

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 (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. Note that patients who were diagnosed initially with lymphoblastic lymphoma but who have relapsed with T-ALL are eligible
  • 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 must be refractory to or have relapsed following a standard induction chemotherapy. A standard chemotherapy induction regimen is defined as any program of treatment that includes:

    • Vincristine and prednisone
    • Vincristine and dexamethasone
    • Cytarabine and anthracycline, or
    • High dose cytarabine (defined as at least 1 gr/m2 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 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. Note that the patients may receive intrathecal chemotherapy with the initial lumbar puncture
  • Prior nelarabine therapy is not required. In addition, patients who receive 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 be >= 18 years of age
  • Patients must have a Zubrod performance status of 0-3
  • Patients must have creatinine clearance > 30 mL/min within 14 days prior to registration according to the Cockcroft Gault equation
  • Patients must have direct bilirubin =< 1.5 x institutional upper limit of normal (ULN) within 14 days prior to registration
  • Patients must have aspartate aminotransferase (AST) and 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) (within 14 days prior to registration to obtain baseline measurements)
  • From comprehensive metabolic panel: sodium, potassium, chloride, carbon dioxide (CO2), and blood urea nitrogen (BUN) (within 14 days prior to registration to obtain baseline measurements)
  • 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 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 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 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 institutional and federal guidelines
  • 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

Exclusion Criteria:

  • Patients must not have had chemotherapy or investigational agents within 14 days prior to registration except for steroids, 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 >= grade 2 acute graft versus host disease (GVHD) or moderate or severe limited chronic GVHD and must have no history of extensive GVHD of any severity within 90 days prior to registration. 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 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 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.

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.
Drug: AKR1C3-activated Prodrug OBI-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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response rate (complete remission [CR] or CR with incomplete count recovery [CRi])
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

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, 2027

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)

February 9, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

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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