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NCT00295971 · ClinicalTrials.gov registry record · Phase 1

Donor Stem Cell Transplant in Treating Young Patients With Myelodysplastic Syndrome, Leukemia, Bone Marrow Failure Syndrome, or Severe Immunodeficiency Disease

A Phase 1 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 1
Development phase
21
Enrollment target

NCT00295971: Completed Phase 1 study, sponsored by University of California, San Francisco.

NCT00295971 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 21 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00295971, a Phase 1 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 1
Development phase
21 participants
Enrollment target

Study Summary

RATIONALE: Giving chemotherapy and total body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's 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. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin and removing the T cells from the donor cells before transplant may stop this from happening. PURPOSE: This phase I trial is studying the side effects and best dose of donor T cells and antithymocyte globulin when given together with chemotherapy and total-body irradiation in treating young patients who are undergoing T-cell depleted donor stem cell transplant for myelodysplastic syndrome, leukemia, bone marrow failure syndrome, or severe immunodeficiency disease.

Interventions

  • DRUG fludarabine phosphate
  • DRUG thiotepa
  • PROCEDURE allogeneic bone marrow transplantation
  • BIOLOGICAL anti-thymocyte globulin
  • BIOLOGICAL therapeutic allogeneic lymphocytes

Trial Details

FieldValue
Enrollment Target 21 participants
Start Date 2005-04
Est. Completion 2011-12
Phase Phase 1

What the finished NCT00295971 record still lists

NCT00295971 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 5 interventions - of which fludarabine phosphate is the first listed.

NCT00295971 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00295971 about?

NCT00295971 is a clinical study titled "Donor Stem Cell Transplant in Treating Young Patients With Myelodysplastic Syndrome, Leukemia, Bone Marrow Failure Syndrome, or Severe Immunodeficiency Disease". RATIONALE: Giving chemotherapy and total body irradiation before a donor bone marrow transplant or peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a don...

What is the current status of trial NCT00295971?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2005-04. Estimated completion is 2011-12.

What interventions are being tested in trial NCT00295971?

The interventions under investigation include: fludarabine phosphate (DRUG), thiotepa (DRUG), allogeneic bone marrow transplantation (PROCEDURE), anti-thymocyte globulin (BIOLOGICAL), therapeutic allogeneic lymphocytes (BIOLOGICAL).

Who is sponsoring clinical trial NCT00295971?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00295971's enrollment target sits among peer trials

21 1615th of 2000 higher than 372 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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Source: ClinicalTrials.gov NCT00295971, the US trial registry maintained by the National Library of Medicine. NCT00295971 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.