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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: | NCT00079391 |
RATIONALE: Giving chemotherapy and total body irradiation before a donor bone marrow transplant or 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. Removing the T cells from the donor cells before transplant and giving cyclosporine before and after the transplant and may stop this from happening. Giving an infusion of the donor's T cells (donor lymphocyte infusion) later may help the patient's immune system see any remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect).
PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients who are undergoing donor stem cell transplant followed by T-cell add-back (reinfusion) for hematologic malignancies.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Lymphoma Myelodysplastic Syndromes |
Drug: cyclophosphamide Drug: cyclosporine Drug: etoposide Drug: fludarabine phosphate Drug: therapeutic allogeneic lymphocytes Procedure: allogeneic bone marrow transplantation 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 Peritransplant Cyclosporine on Chimerism |
Estimated Enrollment: | 20 |
Study Start Date: | December 2003 |
OBJECTIVES:
OUTLINE:
NOTE: *Patients with high-risk leukemias (marrow blasts > 10% on admission) receive etoposide IV over 4 hours on day -3 and cyclophosphamide IV over 1 hour on day -2.
Patients are followed at least weekly up to day 120 post-transplantation, at 6 and 12 months, every 6 months for 1 year, and then annually for at least 3 years.
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 1 of the following hematologic malignancies:
Chronic myelogenous leukemia, including any of the following:
In chronic phase, meeting 1 of the following criteria:
Acute lymphoblastic leukemia, including any of the following:
Over 18 years of age and in first remission with the following high-risk features:
Acute myeloid leukemia, including any of the following:
Myelodysplastic syndromes, including any of the following:
Myeloproliferative disorders in transformation to acute leukemia, including any of the following:
Chronic lymphocytic leukemia, meeting one of the following criteria:
Non-Hodgkin's lymphoma (including mantle cell lymphoma), meeting the following criteria:
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 | |
NIH - 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: | CDR0000355413, NHLBI-04-H-0112 |
Study First Received: | March 8, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00079391 |
Health Authority: | United States: Federal Government |
chronic phase chronic myelogenous leukemia relapsing chronic myelogenous leukemia adult acute lymphoblastic leukemia in remission adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myeloid leukemia in remission recurrent adult acute lymphoblastic leukemia recurrent adult acute myeloid leukemia childhood acute myeloblastic leukemia with maturation (M2) childhood acute myeloblastic leukemia without maturation (M1) childhood acute basophilic leukemia childhood acute monocytic leukemia (M5b) childhood acute eosinophilic leukemia childhood acute erythroleukemia (M6) childhood acute lymphoblastic leukemia in remission |
recurrent childhood acute lymphoblastic leukemia refractory chronic lymphocytic leukemia childhood acute megakaryocytic leukemia (M7) childhood acute minimally differentiated myeloid leukemia (M0) childhood chronic myelogenous leukemia recurrent childhood acute myeloid leukemia childhood acute myeloid leukemia in remission childhood acute monoblastic leukemia (M5a) chronic idiopathic myelofibrosis de novo myelodysplastic syndromes previously treated myelodysplastic syndromes secondary myelodysplastic syndromes polycythemia vera essential thrombocythemia refractory anemia with excess blasts in transformation |
Polycythemia Blast Crisis Cyclosporine Chronic myelogenous leukemia Chronic myelomonocytic leukemia Refractory anemia Miconazole Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Di Guglielmo's syndrome Cyclosporins Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Preleukemia Anemia, Refractory |
Leukemia, Lymphocytic, Chronic, B-Cell Hemorrhagic thrombocythemia Neoplasm Metastasis Thrombocythemia, Hemorrhagic Acute myeloid leukemia, adult Etoposide 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, Myelomonocytic, Chronic |
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 |