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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: Recruiting Phase 1 study of Recurrent T Acute Lymphoblastic Leukemia and Refractory T Acute Lymphoblastic Leukemia, sponsored by SWOG Cancer Research Network.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The regimen will be considered safe and the MTD determined if the dose-limiting toxicity rate is \< 33%.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2021-02-08 |
| Est. Completion | 2028-08-01 |
| Phase | Phase 1 |
What NCT04315324 shows while recruiting
NCT04315324 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (12% higher).
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 names 20 study sites across 9 states, led by 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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Where NCT04315324's enrollment target sits among peer trials
67 783rd of 2000 higher than 1,215 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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