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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00002718 |
RATIONALE: Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.
PURPOSE: Phase II trial to study the effectiveness of T-cell depleted bone marrow and G-CSF stimulated peripheral stem cell transplantation in treating patients with leukemia, lymphoblastic lymphoma, myelodysplastic syndrome, or aplastic anemia.
Condition | Intervention | Phase |
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Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: anti-thymocyte globulin Drug: cyclophosphamide Drug: cytarabine Drug: filgrastim Drug: methylprednisolone Drug: thiotepa Procedure: in vitro-treated bone marrow transplantation Procedure: in vitro-treated peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A PHASE II TRIAL OF T-CELL DEPLETED MARROW GRAFTS COMBINED WITH INFUSIONS OF G-CSF STIMULATED, CD34 CEPRATE STEM CELL COLUMN SELECTED, E-ROSETTE DEPLETED PERIPHERAL BLOOD PROGENITOR CELLS DERIVED FROM HLA HAPLOTYPE MATCHED RELATED DONORS FOR PATIENTS WITH LEUKEMIA LACKING AN HLA-MATCHED RELATED OR UNRELATED DONOR |
Study Start Date: | November 1995 |
OBJECTIVES:
OUTLINE: Patients are stratified by number of HLA-incompatible alleles (1 vs 2 or 3).
Patients with graft failure are offered autologous bone marrow transplantation (BMT) or second allogeneic BMT.
Patients are followed at 1, 3, 6, and 12 months and then annually for 3 years.
PROJECTED ACCRUAL: A total of 60 patients (30 patients per stratum) will be accrued for this study at a rate of 15 leukemia patients and 5 aplastic anemia patients per year.
Ages Eligible for Study: | up to 49 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
One of the following diagnoses:
Acute myelogenous leukemia (AML) meeting 1 of the following conditions:
In first remission but at high risk of relapse because of 1 of the following factors:
Acute lymphocytic leukemia (ALL) meeting 1 of the following conditions:
Availability of a healthy, 1-3 HLA-A, -B, and -DR mismatched related donor
PATIENT CHARACTERISTICS:
Age:
Performance status:
Age 16 and over:
Under age 16:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Richard J. O'Reilly, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000064557, MSKCC-95084, NCI-V96-0809 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00002718 |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia stage IV childhood lymphoblastic lymphoma recurrent childhood lymphoblastic lymphoma recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia relapsing chronic myelogenous leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission |
stage IV adult lymphoblastic lymphoma recurrent adult lymphoblastic lymphoma secondary acute myeloid leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes juvenile myelomonocytic leukemia childhood chronic myelogenous leukemia atypical chronic myeloid leukemia myelodysplastic/myeloproliferative disease, unclassifiable chronic myelomonocytic leukemia childhood myelodysplastic syndromes |
Juvenile myelomonocytic leukemia Leukemia, Lymphoid Chronic myelogenous leukemia Precancerous Conditions Methylprednisolone Chronic myelomonocytic leukemia Prednisolone acetate Cyclophosphamide Leukemia, Myeloid, Chronic-Phase Leukemia, Myeloid, Acute Acute lymphoblastic leukemia, adult Leukemia Preleukemia Neoplasm Metastasis Anemia, Aplastic |
Acute myeloid leukemia, adult Acute myelocytic leukemia Lymphoma Cytarabine Methylprednisolone Hemisuccinate Myelodysplastic syndromes Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Myelodysplasia Myelodysplastic Syndromes Acute myelogenous leukemia Myeloproliferative Disorders |
Antimetabolites Anti-Inflammatory Agents Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antiemetics Hormones Neuroprotective Agents Pathologic Processes Therapeutic Uses Syndrome |
Alkylating Agents Disease Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Gastrointestinal Agents Glucocorticoids Protective Agents Immunosuppressive Agents Antiviral Agents Pharmacologic Actions Neoplasms Autonomic Agents Myeloablative Agonists Antineoplastic Agents, Alkylating |