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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: | NCT00398346 |
RATIONALE: Giving chemotherapy, such as fludarabine and cyclophosphamide, and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cancer or abnormal 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 T cells from the donor cells before transplant and giving cyclosporine or tacrolimus before and after transplant 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 or abnormal cells as not belonging to the patient's body and destroy them (graft-versus-tumor effect).
PURPOSE: This phase II trial is studying how well a donor peripheral blood stem cell transplant works in treating patients with hematologic cancer or other disease.
Condition | Intervention | Phase |
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Cancer-Related Problem/Condition Chronic Myeloproliferative Disorders Graft Versus Host Disease Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases Small Intestine Cancer |
Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Drug: tacrolimus Drug: therapeutic allogeneic lymphocytes Procedure: allogeneic hematopoietic stem cell transplantation Procedure: in vitro-treated peripheral blood stem cell transplantation Procedure: peripheral blood stem cell transplantation Procedure: total-body irradiation |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Peripheral Blood Stem Cell Allotransplantation for Hematological Malignancies Using a Positive Stem Cell Selection Technique for T-Cell Depletion, Followed by Delayed T-Cell Add-Back |
Estimated Enrollment: | 68 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE:
NOTE: *Patients over 55 years of age receive reduced-dose TBI.
After completion of study therapy, patients are followed periodically for 3 years.
Ages Eligible for Study: | 10 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of 1 of the following:
Chronic myelogenous leukemia (CML), meeting 1 of the following criteria:
Ten to 75 years of age with CML in chronic phase, meeting 1 of the following criteria:
Acute lymphoblastic leukemia, meeting 1 of the following criteria:
In first remission with any of the following high-risk features:
Acute myeloid leukemia (AML), meeting 1 of the following criteria:
In first remission
Myelodysplastic syndromes (MDS), including any of the following subtypes:
Myeloproliferative disorders, including any of the following subtypes:
Chronic lymphocytic leukemia
Refractory to fludarabine phosphate treatment AND meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, Maryland | |
NIH - Warren Grant Magnuson Clinical Center | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Clinical Trials Office - NIH - Warren Grant Magnuson Clinical 800-411-1222 |
Study Chair: | Aarthi Shenoy, MD | National Heart, Lung, and Blood Institute (NHLBI) |
Responsible Party: | NHLBI - Hematology Branch ( Aarthi Shenoy ) |
Study ID Numbers: | CDR0000512813, NHLBI-06-H-0248, NHLBI-IDE-13058 |
Study First Received: | November 9, 2006 |
Last Updated: | November 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00398346 |
Health Authority: | Unspecified |
graft versus host disease secondary myelofibrosis de novo myelodysplastic syndromes Philadelphia chromosome negative chronic myelogenous leukemia refractory anemia with excess blasts refractory anemia refractory anemia with excess blasts in transformation previously treated myelodysplastic syndromes atypical chronic myeloid leukemia chronic neutrophilic leukemia chronic idiopathic myelofibrosis polycythemia vera essential thrombocythemia stage III multiple myeloma refractory multiple myeloma |
Waldenstrom macroglobulinemia refractory chronic lymphocytic leukemia childhood chronic myelogenous leukemia relapsing chronic myelogenous leukemia blastic phase chronic myelogenous leukemia adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(15;17)(q22;q12) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) adult acute myeloid leukemia in remission recurrent adult acute myeloid leukemia childhood acute myeloid leukemia in remission recurrent childhood acute myeloid leukemia secondary acute myeloid leukemia |
Philadelphia Chromosome Blast Crisis Cyclosporine Chronic myelogenous leukemia Refractory anemia Lymphoma, small cleaved-cell, diffuse Tacrolimus Cyclosporins Ileal Diseases Small non-cleaved cell lymphoma Lymphoma, large-cell, immunoblastic Lymphomatoid granulomatosis Preleukemia Hemorrhagic Disorders Hemorrhagic thrombocythemia |
Neoplasm Metastasis Thrombocythemia, Hemorrhagic Myelodysplastic syndromes Essential thrombocytosis Precursor Cell Lymphoblastic Leukemia-Lymphoma Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Acute myelogenous leukemia Leukemia, Myeloid Myelodysplastic myeloproliferative disease Waldenstrom Macroglobulinemia Leukemia, Myeloid, Accelerated Phase B-cell lymphomas |
Antimetabolites Anti-Infective Agents Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Neoplasms by Site Pathologic Processes Jejunal Diseases Syndrome Therapeutic Uses Antifungal Agents |
Cardiovascular Diseases Alkylating Agents Dermatologic Agents Disease Neoplasms by Histologic Type Immune System Diseases Enzyme Inhibitors Immunosuppressive Agents Pharmacologic Actions Neoplasms Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents |