RecruitingPhase 1Phase 2NCT04315324

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

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)

Sponsor

SWOG Cancer Research Network

Enrollment

67 participants

Start Date

Feb 8, 2021

Study Type

INTERVENTIONAL

Conditions

Recurrent T Acute Lymphoblastic Leukemia Refractory T Acute Lymphoblastic Leukemia Refractory T Lymphoblastic Lymphoma

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.

Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing OBI-3424, a new experimental drug that specifically targets cancer cells carrying a protein called AKR1C3, in patients with a type of blood cancer called T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL) that has come back or stopped responding to treatment. **You may be eligible if...** - You have a confirmed diagnosis of relapsed or refractory T-ALL or T-LBL - You have at least 5% cancer cells (lymphoblasts) in your blood or bone marrow - Adults (18+) must have failed at least one standard induction chemotherapy - Children under 18 must have relapsed or failed at least 2 chemotherapy cycles - Your organ function (heart, liver, kidneys) meets minimum requirements - Your life expectancy is at least 2 months **You may NOT be eligible if...** - You have cancer only in sites outside the bone marrow (extramedullary disease only) - You have active, uncontrolled infection - You have significant liver disease (including hepatitis) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAKR1C3-activated Prodrug AST-3424

Given IV

PROCEDUREBiopsy Procedure

Undergo biopsy

PROCEDUREBiospecimen Collection

Undergo blood and CSF sample collection

PROCEDUREBone Marrow Aspiration

Undergo bone marrow aspirate

PROCEDUREComputed Tomography

Undergo CT scan

Locations(163)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

Arkansas Children's Hospital

Little Rock, Arkansas, United States

PCR Oncology

Arroyo Grande, California, United States

City of Hope Comprehensive Cancer Center

Duarte, California, United States

Loma Linda University Medical Center

Loma Linda, California, United States

Children's Hospital of Orange County

Orange, California, United States

Children's Hospital Colorado

Aurora, Colorado, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Johns Hopkins All Children's Hospital

St. Petersburg, Florida, United States

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Loyola Center for Health at Burr Ridge

Burr Ridge, Illinois, United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

Northwestern University

Chicago, Illinois, United States

University of Illinois

Chicago, Illinois, United States

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, United States

Loyola Medicine Homer Glen

Homer Glen, Illinois, United States

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, United States

Loyola University Medical Center

Maywood, Illinois, United States

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Melrose Park, Illinois, United States

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, United States

University of Chicago Medicine-Orland Park

Orland Park, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Mary Greeley Medical Center

Ames, Iowa, United States

McFarland Clinic - Ames

Ames, Iowa, United States

McFarland Clinic - Boone

Boone, Iowa, United States

McFarland Clinic - Trinity Cancer Center

Fort Dodge, Iowa, United States

McFarland Clinic - Jefferson

Jefferson, Iowa, United States

McFarland Clinic - Marshalltown

Marshalltown, Iowa, United States

Norton Children's Hospital

Louisville, Kentucky, United States

LSU Health Baton Rouge-North Clinic

Baton Rouge, Louisiana, United States

Our Lady of the Lake Physician Group

Baton Rouge, Louisiana, United States

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, United States

Bronson Battle Creek

Battle Creek, Michigan, United States

Wayne State University/Karmanos Cancer Institute

Detroit, Michigan, United States

Weisberg Cancer Treatment Center

Farmington Hills, Michigan, United States

Corewell Health Grand Rapids Hospitals - Butterworth Hospital

Grand Rapids, Michigan, United States

Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital

Grand Rapids, Michigan, United States

Trinity Health Grand Rapids Hospital

Grand Rapids, Michigan, United States

Bronson Methodist Hospital

Kalamazoo, Michigan, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Beacon Kalamazoo Cancer Center

Kalamazoo, Michigan, United States

Beacon Kalamazoo

Kalamazoo, Michigan, United States

Trinity Health Muskegon Hospital

Muskegon, Michigan, United States

Corewell Health Lakeland Hospitals - Niles Hospital

Niles, Michigan, United States

Cancer and Hematology Centers of Western Michigan - Norton Shores

Norton Shores, Michigan, United States

Corewell Health Reed City Hospital

Reed City, Michigan, United States

Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Corewell Health Lakeland Hospitals - Saint Joseph Hospital

Saint Joseph, Michigan, United States

Munson Medical Center

Traverse City, Michigan, United States

University of Michigan Health - West

Wyoming, Michigan, United States

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Minnesota Oncology - Burnsville

Burnsville, Minnesota, United States

Cambridge Medical Center

Cambridge, Minnesota, United States

Mercy Hospital

Coon Rapids, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Unity Hospital

Fridley, Minnesota, United States

Fairview Clinics and Surgery Center Maple Grove

Maple Grove, Minnesota, United States

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Health Partners Inc

Minneapolis, Minnesota, United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

Monticello Cancer Center

Monticello, Minnesota, United States

New Ulm Medical Center

New Ulm, Minnesota, United States

Fairview Northland Medical Center

Princeton, Minnesota, United States

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

United Hospital

Saint Paul, Minnesota, United States

Saint Francis Regional Medical Center

Shakopee, Minnesota, United States

Lakeview Hospital

Stillwater, Minnesota, United States

Ridgeview Medical Center

Waconia, Minnesota, United States

Rice Memorial Hospital

Willmar, Minnesota, United States

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Fairview Lakes Medical Center

Wyoming, Minnesota, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Carson Tahoe Regional Medical Center

Carson City, Nevada, United States

Cancer and Blood Specialists-Henderson

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, United States

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

GenesisCare USA - Henderson

Henderson, Nevada, United States

Las Vegas Urology - Green Valley

Henderson, Nevada, United States

Las Vegas Urology - Pebble

Henderson, Nevada, United States

Urology Specialists of Nevada - Green Valley

Henderson, Nevada, United States

Las Vegas Urology - Pecos