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

NCT00295971 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2012-11-12

No results posted yet for this 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.

Conditions

Interventions

BIOLOGICAL

anti-thymocyte globulin

BIOLOGICAL

therapeutic allogeneic lymphocytes

DRUG

fludarabine phosphate

DRUG

thiotepa

PROCEDURE

allogeneic bone marrow transplantation

PROCEDURE

allogeneic hematopoietic stem cell transplantation

PROCEDURE

in vitro-treated peripheral blood stem cell transplantation

RADIATION

total-body irradiation

Sponsors & Collaborators

Principal Investigators

  • Morton J. Cowan, MD · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00295971 on ClinicalTrials.gov