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NCT00376519 · ClinicalTrials.gov registry record · Phase 1
Umbilical Cord Blood T-Regulatory Cell Infusion Followed by Donor Umbilical Cord Blood Transplant in Treating Patients With High-Risk Leukemia or Other Hematologic Diseases
A Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Terminated
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT00376519: Clinical Trial Phase 1 study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT00376519 is a Phase 1 study that was terminated before completion, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00376519, a Phase 1 study, was terminated before completion, sponsored by Masonic Cancer Center, University of Minnesota.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer or abnormal cells (graft-versus-tumor effect). Giving an infusion of the donor's T-regulatory cells before the transplant may help increase this effect. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of umbilical cord blood T-regulatory cell infusion followed by donor umbilical cord blood transplant in treating patients with high-risk leukemia or other hematologic diseases.
Primary Outcome
Dose limiting toxicities (DLT) are defined as any grade 3-4 toxicity within 24 hours of Treg cell infusion, excluding hematological .
Interventions
- DRUG cyclophosphamide
- DRUG fludarabine phosphate
- DRUG cyclosporine
- DRUG mycophenolate mofetil
- PROCEDURE Treg cell infusion
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2007-05 |
| Est. Completion | 2008-03 |
| Phase | Phase 1 |
Why NCT00376519 stopped before completion
NCT00376519 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 5 interventions - of which cyclophosphamide is the first listed.
NCT00376519 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00376519 about?
NCT00376519 is a clinical study titled "Umbilical Cord Blood T-Regulatory Cell Infusion Followed by Donor Umbilical Cord Blood Transplant in Treating Patients With High-Risk Leukemia or Other Hematologic Diseases". RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer or abnormal cells and prepares the patient's bone marrow for the stem cells. When the healthy stem cells from ...
What is the current status of trial NCT00376519?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2007-05. Estimated completion is 2008-03.
What interventions are being tested in trial NCT00376519?
The interventions under investigation include: cyclophosphamide (DRUG), fludarabine phosphate (DRUG), cyclosporine (DRUG), mycophenolate mofetil (DRUG), Treg cell infusion (PROCEDURE).
Who is sponsoring clinical trial NCT00376519?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00376519's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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