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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00295971 |
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.
Condition | Intervention | Phase |
---|---|---|
Congenital Amegakaryocytic Thrombocytopenia Leukemia Myelodysplastic Syndromes Severe Congenital Neutropenia |
Drug: anti-thymocyte globulin Drug: fludarabine phosphate Drug: therapeutic allogeneic lymphocytes Drug: thiotepa Procedure: allogeneic bone marrow transplantation Procedure: allogeneic hematopoietic stem cell transplantation Procedure: in vitro-treated peripheral blood stem cell transplantation Procedure: total-body irradiation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Stem Cell Enriched, T Cell Depleted Haplocompatible Peripheral Blood Transplantation for Children With Myelodysplastic Disease, Leukemia, Marrow Failure Syndromes, or Severe Immunodeficiency Diseases |
Estimated Enrollment: | 21 |
Study Start Date: | April 2005 |
OBJECTIVES:
OUTLINE: This is a dose-escalation study of donor CD3+ cells and antithymocyte globulin (ATG).
Cohorts of 3-6 patients receive escalating doses of donor CD3+ cells and ATG until the optimum is determined. The optimum dose is defined as the dose at which both engraftment and T-cell recovery occur, without dose-limiting toxicity, in ≥ 5 of 6 patients.
After the completion of study treatment, patients are followed periodically for 5 years and then every 5 years thereafter.
PROJECTED ACCRUAL: A total of 21 patients will be accrued for this study.
Ages Eligible for Study: | 1 Year to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of one of the following:
High-risk myelodysplastic syndromes
Chronic myelogenous leukemia in second chronic phase
Severe aplastic anemia, defined as absolute neutrophil count < 500/mm^3 and platelet and/or red blood cell transfusion dependent
Inherited immunodeficiency disease involving neutrophils or lymphocytes, including any of the following:
Haplocompatible related donor, including parent, cousin, aunt, uncle, grandparent, half-sibling, or sibling (≥ 12 years of age), available
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
UCSF Helen Diller Family Comprehensive Cancer Center | Recruiting |
San Francisco, California, United States, 94115 | |
Contact: Clinical Trials Office - UCSF Helen Diller Family Comprehensi 877-827-3222 | |
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente 877-668-0683; 919-966-4432 |
Study Chair: | Morton J. Cowan, MD | UCSF Helen Diller Family Comprehensive Cancer Center |
Study ID Numbers: | CDR0000462168, UCSF-01151, UCSF-H411-17122-07 |
Study First Received: | February 23, 2006 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00295971 |
Health Authority: | Unspecified |
childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes secondary acute myeloid leukemia juvenile myelomonocytic leukemia |
chronic phase chronic myelogenous leukemia refractory anemia with excess blasts in transformation refractory anemia with excess blasts severe congenital neutropenia congenital amegakaryocytic thrombocytopenia childhood chronic myelogenous leukemia childhood myelodysplastic syndromes |
Juvenile myelomonocytic leukemia Leukemia, Lymphoid Severe congenital neutropenia Chronic myelogenous leukemia Precancerous Conditions Refractory anemia Bone Marrow failure syndromes Leukocyte Disorders Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid, Acute Granulocytopenia Leukemia Preleukemia Thrombocytopenia Anemia, Refractory |
Neoplasm Metastasis Acute myelocytic leukemia Myelodysplastic syndromes Congenital amegakaryocytic thrombocytopenia Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Blood Platelet Disorders Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia Anemia Agranulocytosis Pancytopenia Fludarabine monophosphate Leukemia, Myelomonocytic, Juvenile |
Antimetabolites Neoplasms by Histologic Type Disease Antimetabolites, Antineoplastic Immune System Diseases Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions Neoplasms Pathologic Processes Therapeutic Uses Syndrome |