Donor Bone Marrow Transplant in Treating Patients With Leukemia, Lymphoma, or Nonmalignant Hematologic Disorders
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.
|Chronic Myeloproliferative Disorders Leukemia Multiple Myeloma and Malignant Plasma Cell Neoplasms Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms||Drug: cyclophosphamide Radiation: TBI||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Allogeneic Bone Marrow Transplantation Using Closely Matched Related and Unrelated Donors|
- event free survival (EFS) [ Time Frame: five year post transplant ]EFS determined by the Kaplan-Meier product limit method
- Incidence of graft versus host disease [ Time Frame: five years post transplant ]incidence and severity of acute and chronic GVHD
|Study Start Date:||May 1996|
|Study Completion Date:||July 2009|
|Primary Completion Date:||September 2005 (Final data collection date for primary outcome measure)|
cyclophosphamide and total body irradiation (TBI)
Cyclophosphamide is administered at a dose of 60 mg/kg on each of two successive days (Days -6 and -5)Radiation: TBI
FTBI is performed on day -3 through day 0 The total dose of radiation is 1,320 cGy.
- Determine the survival of allogeneic bone marrow transplantation using closely matched related and unrelated donors in patients with malignant or nonmalignant hematological disorders.
- Determine the incidence and severity of acute and chronic graft versus host disease with this treatment regimen in these patients.
- Determine the relapse rates with this treatment regimen in those patients with malignant disorders.
- Determine the incidence and severity of infectious complications associated with this treatment regimen in these patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005622
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||Teresa Field, MD, PhD||H. Lee Moffitt Cancer Center and Research Institute|