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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005622 |
RATIONALE: Giving chemotherapy and total-body irradiation before a donor bone marrow 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 stem cells from a related or unrelated donor, that closely matches the patient's blood, are infused into the patient they may help the patient's bone marrow to make stem cells, red blood cells, white blood cells, and platelets.
PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with leukemia, lymphoma, or nonmalignant hematologic disorders.
Condition | Intervention | Phase |
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Chronic Myeloproliferative Disorders Leukemia Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Diseases |
Drug: cyclophosphamide Drug: leucovorin calcium Drug: methotrexate Procedure: allogeneic bone marrow transplantation Radiation: radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors |
Study Start Date: | June 2000 |
OBJECTIVES:
OUTLINE: Patients receive cyclophosphamide IV over 1 hour on days -6 and -5, total body radiotherapy on days -3 through 0, and allogeneic bone marrow transplantation on day 0.
Patients with acute lymphocytic leukemia (ALL) receive intrathecal methotrexate at the beginning of the study. If CNS involvement is documented, patients receive a second dose of methotrexate 48 hours later followed by oral leucovorin calcium every 6 hours for 4 doses. Patients with ALL and/or CNS involvement receive intrathecal methotrexate every other week for 12 weeks after transplant.
Patients with prior CNS involvement receive radiotherapy for 2.5 weeks prior to transplant. Patients with ALL receive total body radiotherapy for 5 consecutive days prior to transplant.
Patients are followed once a week for 3 months, and then monthly for 1 year.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study over 6 years.
Ages Eligible for Study: | 15 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed diagnosis of one of the following:
Acute lymphocytic leukemia (ALL):
Acute myelogenous leukemia (AML):
Chronic myelogenous leukemia (CML):
Chronic lymphocytic leukemia (CLL):
Multiple myeloma:
Severe aplastic anemia (SAA):
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, Florida | |
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida | |
Tampa, Florida, United States, 33612-9497 |
Study Chair: | Teresa Field, MD, PhD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | CDR0000067763, MCC-11282, MCC-IRB-4189, NCI-G00-1755 |
Study First Received: | May 2, 2000 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00005622 History of Changes |
Health Authority: | United States: Federal Government |
recurrent childhood acute lymphoblastic leukemia refractory multiple myeloma stage I multiple myeloma stage II multiple myeloma stage III multiple myeloma stage I chronic lymphocytic leukemia stage II chronic lymphocytic leukemia stage III chronic lymphocytic leukemia stage IV chronic lymphocytic leukemia recurrent childhood acute myeloid leukemia recurrent adult acute myeloid leukemia recurrent adult acute lymphoblastic leukemia refractory chronic lymphocytic leukemia chronic phase chronic myelogenous leukemia accelerated phase chronic myelogenous leukemia |
blastic phase chronic myelogenous leukemia adult acute myeloid leukemia in remission adult acute lymphoblastic leukemia in remission childhood acute myeloid leukemia in remission childhood acute lymphoblastic leukemia in remission polycythemia vera chronic idiopathic myelofibrosis essential thrombocythemia refractory anemia refractory anemia with ringed sideroblasts refractory anemia with excess blasts refractory anemia with excess blasts in transformation chronic myelomonocytic leukemia de novo myelodysplastic syndromes previously treated myelodysplastic syndromes |
Polycythemia Chronic Myelomonocytic Leukemia Blast Crisis Refractory Anemia Preleukemia Acute Myelocytic Leukemia Anemia, Refractory Hemorrhagic Disorders Acute Myeloid Leukemia, Adult Leukemia, Lymphocytic, Chronic, B-Cell Neoplasm Metastasis Methotrexate Thrombocythemia, Hemorrhagic Myelodysplastic Myeloproliferative Disease Precursor Cell Lymphoblastic Leukemia-Lymphoma |
Immunoproliferative Disorders Hematologic Diseases Leukemia, Myeloid, Chronic, Atypical, BCR-ABL Negative Leukemia, Myelomonocytic, Chronic Blood Coagulation Disorders Myeloproliferative Disorders Leukemia, Myeloid Multiple Myeloma Folic Acid Leukemia, Myeloid, Accelerated Phase Chronic Myelogenous Leukemia Antimetabolites Acute Lymphoblastic Leukemia, Childhood Leukemia, Lymphoid Immunologic Factors |
Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Preleukemia Hemorrhagic Disorders Pathologic Processes Therapeutic Uses Abortifacient Agents Methotrexate Cardiovascular Diseases Dermatologic Agents Nucleic Acid Synthesis Inhibitors Immunoproliferative Disorders Immune System Diseases Hematologic Diseases |
Myeloproliferative Disorders Abortifacient Agents, Nonsteroidal Multiple Myeloma Neoplasms Antimetabolites Precancerous Conditions Immunologic Factors Blood Protein Disorders Antineoplastic Agents Leucovorin Paraproteinemias Cyclophosphamide Reproductive Control Agents Hemostatic Disorders Leukemia |