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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00080925 |
RATIONALE: Donor peripheral stem cell transplantation may be able to replace bone marrow and immune cells that were destroyed by chemotherapy. Sometimes the transplanted cells from a donor are rejected by the body's normal cells. Eliminating the T cells from the donor cells before transplanting them and giving cyclosporine may prevent this from happening.
PURPOSE: This phase I trial is studying the side effects of T-cell-depleted allogeneic stem cell transplantation after immunoablative induction chemotherapy and reduced-intensity transplantation conditioning (chemotherapy) in treating patients with hematologic malignancies.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclophosphamide Drug: cyclosporine Drug: cytarabine Drug: doxorubicin hydrochloride Drug: etoposide Drug: filgrastim Drug: fludarabine phosphate Drug: prednisone Drug: rituximab Drug: therapeutic allogeneic lymphocytes Drug: vincristine sulfate Procedure: graft-versus-tumor induction therapy Procedure: peripheral blood stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | T-Cell Depleted, Reduced-Intensity Allogeneic Stem Cell Transplantation From Haploidentical Related Donors For Hematologic Malignancies |
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following hematologic malignancies:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
In first complete remission (CR1), meeting 1 of the following criteria:
Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, fluorescence in situ hybridization (FISH), or polymerase chain reaction (PCR), defined as 1 of the following:
Acute lymphoblastic leukemia, meeting 1 of the following criteria:
In CR1, meeting 1 of the following criteria:
Adverse cytogenetics with minimal residual disease detectable by flow cytometry, cytogenetic analysis, FISH, or PCR, defined as the following:
Myelodysplastic syndromes (MDS)
Chronic myelogenous leukemia (CML), meeting 1 of the following criteria:
Myeloproliferative disorders, meeting 1 of the following criteria:
Agnogenic myeloid metaplasia with adverse-risk features, meeting at least 2 of the following criteria:
Myelodysplastic/myeloproliferative disease
Hodgkin's lymphoma or non-Hodgkin's lymphoma
Chronic lymphocytic leukemia
Prolymphocytic leukemia (PLL), meeting 1 of the following criteria:
T-PLL
B-PLL
Multiple myeloma, meeting 1 of the following criteria:
Adverse cytogenetics, defined as 1 of the following:
Less than 10% blasts in bone marrow and no circulating blasts in peripheral blood for the following diagnoses:
No active CNS involvement by malignancy*
Availability of a donor who is a sibling, parent, or offspring who shares 1 full haplotype (HLA-A, -B, or -DR)
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
No chronic active hepatitis B infection
No hepatitis C viral infection
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Maryland | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937 |
Study Chair: | Michael R. Bishop, MD | National Cancer Institute (NCI) |
Study ID Numbers: | CDR0000357432, NCI-04-C-0116 |
Study First Received: | April 7, 2004 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00080925 |
Health Authority: | Unspecified |
prolymphocytic leukemia accelerated phase chronic myelogenous leukemia chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia refractory chronic lymphocytic leukemia de novo myelodysplastic syndromes myelodysplastic/myeloproliferative disease, unclassifiable previously treated myelodysplastic syndromes secondary myelodysplastic syndromes secondary acute myeloid leukemia recurrent adult Hodgkin lymphoma refractory anemia with excess blasts refractory multiple myeloma chronic idiopathic myelofibrosis recurrent adult diffuse large cell lymphoma |
recurrent adult diffuse mixed cell lymphoma recurrent adult diffuse small cleaved cell lymphoma recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 1 follicular lymphoma recurrent grade 2 follicular lymphoma recurrent grade 3 follicular lymphoma recurrent adult Burkitt lymphoma recurrent mantle cell lymphoma adult acute lymphoblastic leukemia in remission adult acute myeloid leukemia in remission chronic myelomonocytic leukemia polycythemia vera essential thrombocythemia stage II multiple myeloma |
Polycythemia Prednisone Cyclosporine Chronic myelogenous leukemia Chronic myelomonocytic leukemia Refractory anemia Miconazole Hodgkin lymphoma, adult Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Cyclosporins Lymphoma, large-cell, immunoblastic Preleukemia Hemorrhagic Disorders Leukemia, Prolymphocytic |
Anemia, Refractory Multiple myeloma Leukemia, Lymphocytic, Chronic, B-Cell Hemorrhagic thrombocythemia Neoplasm Metastasis Thrombocythemia, Hemorrhagic Acute myeloid leukemia, adult Etoposide Hodgkin Disease Essential thrombocytosis Chronic lymphocytic leukemia Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders |
Anti-Inflammatory Agents Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Antibiotics, Antineoplastic Hormones Neoplasms by Site Pathologic Processes Syndrome Therapeutic Uses |
Antifungal Agents Cardiovascular Diseases Alkylating Agents Dermatologic Agents Disease Neoplasms by Histologic Type Antineoplastic Agents, Hormonal Immune System Diseases Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Glucocorticoids Antiviral Agents Immunosuppressive Agents Pharmacologic Actions |