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NCT01497184 · ClinicalTrials.gov registry record · Phase 1
Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 95
- Enrollment target
NCT01497184: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01497184 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 95 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01497184, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 95 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if researchers can successfully and safely give HSCT patients an infusion of white blood cells (called T-cells) that have been genetically changed. The process of changing the DNA (the genetic material in cells) of these T-cells is called "gene transfer." Researchers want to learn if these genetically-changed T-cells are effective in attacking cancer cells in patients with advanced B-cell lymphoma or leukemia, after they have received standard allogeneic HSCT. Researchers want to find out the highest dose of these special T-cells that can be given safely to leukemia and lymphoma patients. Researchers also want to learn how long the changed T-cells stay in your body, and if adding them to standard transplant can improve how you respond to treatment.
Primary Outcome
MTD is highest dose level where 2 of 6 treated participants have dose limiting toxicity (DLT). DLT defined as new adverse event attributable to donor lymphocyte infusion (DLI) grade 3 or \> involving cardiopulmonary, gastrointestinal, hepatic (excluding albumin), neurological, or renal common toxicity criteria (CTC) version 4 parameters, lasts \> 3 days and possibly related to DLI within 30 days of infusion.
Interventions
- PROCEDURE HSCT
- GENETIC DLI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 2011-12 |
| Est. Completion | 2021-03-08 |
| Phase | Phase 1 |
What the finished NCT01497184 record still lists
NCT01497184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 95 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (58% higher).
The record links to 0 conditions, and to 2 interventions - of which HSCT is the first listed.
NCT01497184 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01497184 about?
NCT01497184 is a clinical study titled "Infusion of Allogeneic CD19-Specific T Cells From Peripheral Blood". The goal of this clinical research study is to learn if researchers can successfully and safely give HSCT patients an infusion of white blood cells (called T-cells) that have been genetically changed. The process of changing the DNA (the genetic material in cells) of these T-cells is called "gene tr...
What is the current status of trial NCT01497184?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2011-12. Estimated completion is 2021-03-08.
What interventions are being tested in trial NCT01497184?
The interventions under investigation include: HSCT (PROCEDURE), DLI (GENETIC).
Who is sponsoring clinical trial NCT01497184?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01497184's enrollment target sits among peer trials
95 610th of 2000 higher than 1,386 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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