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NCT01362452 · ClinicalTrials.gov registry record · Phase 1
Infusion of Allogeneic Umbilical Cord Blood-Derived Cluster of Differentiation Antigen 19 (CD19)-Specific T Cells
A Phase 1 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT01362452: Completed Phase 1 study, sponsored by M.D. Anderson Cancer Center.
NCT01362452 is a Phase 1 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 5 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01362452, a Phase 1 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if an infusion of white blood cells (called T cells) that have been genetically changed is safe to give patients who have received an umbilical cord blood transplant (UCBT). 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 an UCBT, how long the changed T-cells stay in the body, and if adding them to standard transplant could improve how patients respond to treatment. Funding Source - FDA OOPD
Primary Outcome
MTD is highest dose level in which 6 participants treated with at most 2 experiencing dose-limiting toxicity (DLT) using Common Toxicity Criteria (CTC) following the t-cell infusion Day 42 to Day 100.
Interventions
- PROCEDURE Cord Blood Infusion
- GENETIC T-Cell Infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2012-12-07 |
| Est. Completion | 2017-07-25 |
| Phase | Phase 1 |
What the finished NCT01362452 record still lists
NCT01362452 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Cord Blood Infusion is the first listed.
NCT01362452 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01362452 about?
NCT01362452 is a clinical study titled "Infusion of Allogeneic Umbilical Cord Blood-Derived Cluster of Differentiation Antigen 19 (CD19)-Specific T Cells". The goal of this clinical research study is to learn if an infusion of white blood cells (called T cells) that have been genetically changed is safe to give patients who have received an umbilical cord blood transplant (UCBT). Researchers want to learn if these genetically changed T-cells are effect...
What is the current status of trial NCT01362452?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2012-12-07. Estimated completion is 2017-07-25.
What interventions are being tested in trial NCT01362452?
The interventions under investigation include: Cord Blood Infusion (PROCEDURE), T-Cell Infusion (GENETIC).
Who is sponsoring clinical trial NCT01362452?
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 NCT01362452's enrollment target sits among peer trials
5 1989th of 2000 higher than 6 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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