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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 is a Phase 1 study that has completed, run by University of California, San Francisco. The registered enrollment target is 21 participants.

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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 Registry Record Tells You About NCT00295971

The ClinicalTrials.gov registry entry for NCT00295971 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, San Francisco, which has 1,713 total studies on file at ClinicalTrials.gov.

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

NCT00295971 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.