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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00066300 |
RATIONALE: Peripheral stem cell transplantation may be able to replace 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 may prevent this from happening. Infusions of donor lymphocytes may decrease the body's rejection of the transplanted peripheral stem cells.
PURPOSE: Phase II trial to study the effectiveness of allogeneic stem cell transplantation followed by donor lymphocyte infusions in treating patients who have hematologic cancer.
Condition | Intervention | Phase |
---|---|---|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: therapeutic allogeneic lymphocytes Procedure: allogeneic bone marrow transplantation Procedure: graft-versus-tumor induction therapy Procedure: peripheral blood stem cell transplantation Procedure: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Peripheral Blood Mobilized Hematopoietic Precursor Cell Transplantation Followed By T Cell Add-Back For Hematological Malignancies - Effect Of Irradiated Donor Lymphocytes On Chimerism |
Study Start Date: | May 2003 |
OBJECTIVES:
OUTLINE:
Patients are followed at 3, 6, and 12 months and then annually thereafter.
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Ages Eligible for Study: | 10 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of any of the following hematologic malignancies:
Chronic myelogenous leukemia (CML) in chronic phase meeting 1 of the following criteria:
Acute lymphoblastic leukemia meeting any of the following criteria:
Acute myeloid leukemia meeting any of the following criteria:
Myelodysplastic syndromes of any of the following types:
Myeloproliferative disorders in transformation to acute leukemia, of any of the following types:
Chronic lymphocytic leukemia that is refractory to fludarabine with 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Maryland | |
Warren Grant Magnuson Clinical Center | |
Bethesda, Maryland, United States, 20892-1182 |
Study Chair: | Austin J. Barrett, MD, FRCP | NHLBI - Bone Marrow Transplantation Unit |
Study ID Numbers: | CDR0000315460, NHLBI-03-H-0192 |
Study First Received: | August 6, 2003 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00066300 |
Health Authority: | United States: Federal Government |
chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia blastic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia chronic idiopathic myelofibrosis polycythemia vera essential thrombocythemia adult acute lymphoblastic leukemia in remission recurrent adult acute lymphoblastic leukemia adult acute myeloid leukemia in remission recurrent adult acute myeloid leukemia refractory chronic lymphocytic leukemia recurrent adult diffuse large cell lymphoma recurrent adult diffuse mixed cell lymphoma recurrent adult Burkitt lymphoma |
recurrent adult immunoblastic large cell lymphoma recurrent adult lymphoblastic lymphoma recurrent grade 3 follicular lymphoma recurrent mantle cell lymphoma refractory anemia with excess blasts in transformation refractory anemia with excess blasts chronic myelomonocytic leukemia refractory anemia childhood acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission recurrent childhood acute lymphoblastic leukemia recurrent childhood acute myeloid leukemia previously treated myelodysplastic syndromes secondary myelodysplastic syndromes de novo myelodysplastic syndromes |
Polycythemia Blast Crisis Cyclosporine Chronic myelogenous leukemia Chronic myelomonocytic leukemia Refractory anemia Miconazole Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Cyclosporins Lymphoma, large-cell, immunoblastic Preleukemia Anemia, Refractory Leukemia, Lymphocytic, Chronic, B-Cell Hemorrhagic thrombocythemia |
Neoplasm Metastasis Thrombocythemia, Hemorrhagic Acute myeloid leukemia, adult Essential thrombocytosis Chronic lymphocytic leukemia Myelodysplastic syndromes Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, B-cell, chronic Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Acute myelogenous leukemia Myeloproliferative Disorders |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Immune System Diseases Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Pathologic Processes Antifungal Agents Syndrome Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Dermatologic Agents Alkylating Agents |