Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00305708 |
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.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Congenital Amegakaryocytic Thrombocytopenia Diamond-Blackfan Anemia Fanconi Anemia Leukemia Severe Congenital Neutropenia |
Drug: anti-thymocyte globulin Drug: busulfan Drug: fludarabine phosphate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy Procedure: umbilical cord blood transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Bone Marrow Stem Cell Transplantation for Children With Stem Cell Defects, Marrow Failure Syndromes, or Myeloid Leukemia in 1Remission |
Estimated Enrollment: | 40 |
Study Start Date: | August 2000 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive one of the following cytoreductive regimens:
All patients undergo allogeneic bone marrow, umbilical cord blood, or peripheral blood stem cell transplantation on day 0.
After the completion of study treatment, patients are followed periodically for 20 years.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Ages Eligible for Study: | up to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following hematopoietic disorders:
Severe aplastic anemia with marrow aplasia (i.e., absolute neutrophil count < 500/mm^3, platelet and/or red blood cell transfusion dependent), meeting 1 of the following criteria:
Congenital marrow failure syndrome, including any of the following:
Hemoglobinopathy including any of the following:
Severe immunodeficiency disease including any of the following:
Chronic myelogenous leukemia in first chronic phase
Acute myeloid leukemia in first remission
Available donor, meeting 1 of the following criteria:
Unrelated donor, meeting one of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Comprehensive Cancer Center | |
San Francisco, California, United States, 94115 |
Study Chair: | Morton J. Cowan, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000462443, UCSF-01152, UCSF-H411-17802-06 |
Study First Received: | March 21, 2006 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00305708 |
Health Authority: | United States: Federal Government |
thrombocytopenia childhood acute myeloid leukemia in remission childhood chronic myelogenous leukemia Diamond-Blackfan anemia |
congenital amegakaryocytic thrombocytopenia Fanconi anemia severe congenital neutropenia chronic phase chronic myelogenous leukemia |
Severe congenital neutropenia Chronic myelogenous leukemia Leukocyte Disorders Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid, Acute Granulocytopenia Red-Cell Aplasia, Pure Leukemia Thrombocytopenia Fanconi's anemia Anemia, Aplastic Anemia, Diamond-Blackfan Acute myelocytic leukemia Congenital amegakaryocytic thrombocytopenia Metabolic Diseases |
Hematologic Diseases Fanconi Anemia Blood Platelet Disorders Aase syndrome Anemia Myeloproliferative Disorders Agranulocytosis Acute myelogenous leukemia Fludarabine monophosphate Leukemia, Myeloid Antilymphocyte Serum Thrombocytopathy Neutropenia Genetic Diseases, Inborn Busulfan |
Anemia, Hypoplastic, Congenital Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents DNA Repair-Deficiency Disorders |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Alkylating Agents |