Busulfan, Antithymocyte Globulin, and Fludarabine Followed By a Donor Stem Cell Transplant in Treating Young Patients With Blood Disorders, Bone Marrow Disorders, Chronic Myelogenous Leukemia in First Chronic Phase, or Acute Myeloid Leukemia in First Remission
NCT00305708 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2012-11-12
Summary
RATIONALE: Drugs used in chemotherapy, such as busulfan and fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. A donor peripheral blood, bone marrow , or umbilical cord blood transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving antithymocyte globulin before the transplant may stop this from happening.
PURPOSE: This phase I/II trial is studying the side effects of busulfan, antithymocyte globulin, and fludarabine when given together with a donor stem cell transplant in treating young patients with blood disorders, bone marrow disorders, chronic myelogenous leukemia in first chronic phase, or acute myeloid leukemia in first remission.
Conditions
- Congenital Amegakaryocytic Thrombocytopenia
- Diamond-blackfan Anemia
- Fanconi Anemia
- Leukemia
- Severe Congenital Neutropenia
- Thrombocytopenia
Interventions
- BIOLOGICAL
-
anti-thymocyte globulin
- DRUG
-
busulfan
- DRUG
-
fludarabine phosphate
- PROCEDURE
-
allogeneic bone marrow transplantation
- PROCEDURE
-
peripheral blood stem cell transplantation
- PROCEDURE
-
umbilical cord blood transplantation
- RADIATION
-
radiation therapy
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
University of California, San Francisco
lead OTHER
Principal Investigators
-
Morton J. Cowan, MD · University of California, San Francisco
Study Design
- Purpose
- TREATMENT
- Masking
- NONE
Eligibility
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-08-31
- Primary Completion
- 2004-07-31
- Completion
- 2004-07-31
Countries
- United States
Study Locations
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