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NCT04315324 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Recurrent T Acute Lymphoblastic Leukemia and Refractory T Acute Lymphoblastic Leukemia, sponsored by SWOG Cancer Research Network.

Recruiting
Registry status
Phase 1
Development phase
67
Enrollment target
20
Study locations

NCT04315324 is a Phase 1 study of Recurrent T Acute Lymphoblastic Leukemia and Refractory T Acute Lymphoblastic Leukemia that is actively recruiting participants, run by SWOG Cancer Research Network. The registered enrollment target is 67 participants. The trial reports 20 study locations across 9 states.

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The verdict

NCT04315324, a Phase 1 study of Recurrent T Acute Lymphoblastic Leukemia and Refractory T Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by SWOG Cancer Research Network.

RECRUITING
Registry status
Phase 1
Development phase
67 participants
Enrollment target
20
Study locations

Study 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.

Conditions Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Computed Tomography
  • PROCEDURE Biopsy Procedure
  • DRUG AKR1C3-activated Prodrug AST-3424

Study Locations (20)

Illinois

  • Loyola Center for Health at Burr Ridge - Burr Ridge
  • Lurie Children's Hospital-Chicago - Chicago
  • Northwestern University - Chicago
  • University of Illinois - Chicago
  • University of Chicago Comprehensive Cancer Center - Chicago

California

  • PCR Oncology - Arroyo Grande
  • City of Hope Comprehensive Cancer Center - Duarte
  • Loma Linda University Medical Center - Loma Linda
  • Children's Hospital of Orange County - Orange

Florida

  • Golisano Children's Hospital of Southwest Florida - Fort Myers
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital - Hollywood
  • Johns Hopkins All Children's Hospital - St. Petersburg

Georgia

  • Emory University Hospital/Winship Cancer Institute - Atlanta
  • Children's Healthcare of Atlanta - Arthur M Blank Hospital - Atlanta
  • Augusta University Medical Center - Augusta

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Arizona

  • Kingman Regional Medical Center - Kingman

Arkansas

  • Arkansas Children's Hospital - Little Rock

Colorado

  • Children's Hospital Colorado - Aurora

Trial Details

FieldValue
Enrollment Target 67 participants
Start Date 2021-02-08
Est. Completion 2028-08-01
Phase Phase 1

Sponsor

SWOG Cancer Research Network

270 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04315324

The ClinicalTrials.gov registry entry for NCT04315324 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 67 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is SWOG Cancer Research Network, which has 270 total studies on file at ClinicalTrials.gov.

The record links to 4 conditions, with Recurrent T Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT04315324 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Illinois, California, Florida.

Frequently Asked Questions

What is clinical trial NCT04315324 about?

NCT04315324 is a clinical study titled "Study to Test OBI-3424 in Patients With T-Cell Acute Lymphoblastic Leukemia (T-ALL) or 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 ...

What is the current status of trial NCT04315324?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 67 participants. The study started on 2021-02-08. Estimated completion is 2028-08-01.

What conditions does trial NCT04315324 study?

This clinical trial studies the following conditions: Recurrent T Acute Lymphoblastic Leukemia, Refractory T Acute Lymphoblastic Leukemia, Refractory T Lymphoblastic Lymphoma, T Lymphoblastic Lymphoma.

What interventions are being tested in trial NCT04315324?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Computed Tomography (PROCEDURE), Biopsy Procedure (PROCEDURE), AKR1C3-activated Prodrug AST-3424 (DRUG).

Who is sponsoring clinical trial NCT04315324?

This trial is sponsored by SWOG Cancer Research Network, which has 270 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04315324 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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