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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00066300 |
Purpose
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 |
Biological: graft-versus-tumor induction therapy Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Procedure: allogeneic bone marrow transplantation Procedure: peripheral blood stem cell transplantation Radiation: 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:
PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000315460, NHLBI-03-H-0192 |
| Study First Received: | August 6, 2003 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00066300 History of Changes |
| 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 Chronic Myelomonocytic Leukemia Blast Crisis Cyclosporine Lymphoma, Mantle-Cell Mantle Cell Lymphoma Cyclosporins Follicular Lymphoma Refractory Anemia Preleukemia Acute Myelocytic Leukemia Anemia, Refractory Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis |
Thrombocythemia, Hemorrhagic Myelodysplastic Myeloproliferative Disease Lymphoma, Large B-Cell, Diffuse Precursor Cell Lymphoblastic Leukemia-Lymphoma Immunoproliferative Disorders Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Myeloproliferative Disorders Leukemia, Myeloid B-cell Lymphomas Leukemia, Myeloid, Accelerated Phase Fludarabine Chronic Myelogenous Leukemia Lymphoma, Non-Hodgkin |
|
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Cyclosporine Molecular Mechanisms of Pharmacological Action Precancerous Conditions Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Cyclophosphamide Cyclosporins Leukemia Preleukemia Pathologic Processes Antifungal Agents |
Therapeutic Uses Syndrome Dermatologic Agents Alkylating Agents Lymphoma Immunoproliferative Disorders Neoplasms by Histologic Type Disease Immune System Diseases Hematologic Diseases Myelodysplastic Syndromes Myeloproliferative Disorders Enzyme Inhibitors Fludarabine monophosphate Immunosuppressive Agents |