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RECRUITING Phase 1

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

NCT04315324 · View on ClinicalTrials.gov ↗

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.

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

212 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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. 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 212 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04315324 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Illinois, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04315324?

This trial is sponsored by SWOG Cancer Research Network, which has 212 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial