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Donor Bone Marrow Transplantation in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
This study is currently recruiting patients.
Sponsored by: | H. Lee Moffitt Cancer Center and Research Institute |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or total-body irradiation used to kill leukemia and lymphoma cells. Bone marrow transplantation using donated bone marrow may be an effective treatment for malignant or nonmalignant hematologic disorders.
PURPOSE: Phase II trial to study the effectiveness of donor bone marrow transplantation in treating patients who have leukemia, lymphoma, or nonmalignant hematologic disorders.
Condition | Treatment or Intervention | Phase |
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acute leukemia atypical chronic myeloid leukemia chronic leukemia chronic myeloproliferative disorders myelodysplastic and myeloproliferative disease plasma cell neoplasm |
Drug: cyclophosphamide Drug: leucovorin calcium Drug: methotrexate Procedure: allogeneic bone marrow transplantation Procedure: biological response modifier therapy Procedure: bone marrow ablation with stem cell support Procedure: bone marrow transplantation Procedure: chemotherapy Procedure: radiation therapy |
Phase II |
MedlinePlus related topics: Bone Marrow Diseases; Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood; Lymphoma
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors In Patients With Malignant or Nonmalignant Hematologic Disorders
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.
Eligibility
Ages Eligible for Study: 15 Years - 50 Years, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Location and Contact Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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