Bone Marrow Transplant in Treating Patients With Hematologic Cancers
- Conditions
- Multiple Myeloma and Malignant Plasma Cell NeoplasmsMyelodysplastic/Myeloproliferative NeoplasmsLeukemiaChronic Myeloproliferative DisordersMyelodysplastic Syndromes
- Interventions
- Radiation: Fractionated Total Body Irradiation (FTBI)
- Registration Number
- NCT00005797
- Brief Summary
RATIONALE: Giving chemotherapy drugs 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 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.
PURPOSE: This phase II trial is studying how well donor bone marrow transplant works in treating patients with hematologic cancers.
- Detailed Description
OBJECTIVES:
* Determine the progression free survival (PFS) and overall survival (OS) of patients with low risk myeloid disorders or older allogeneic recipients who are treated with high dose busulfan and cyclophosphamide and allogeneic bone marrow transplantation (BMT).
* Determine the PFS and OS in patients with lymphoid and high risk myeloid disorders who are treated with etoposide, total body irradiation, and allogeneic BMT.
* Evaluate the toxicities of these 2 regimens when combined with cyclosporine and methotrexate as graft versus host disease prophylaxis in these patients.
* Evaluate the PFS and OS of allogeneic BMT in patients with multiple myeloma and chronic lymphocytic leukemia.
OUTLINE:
* Regimen A: Patients with chronic myelogenous leukemia (CP1, AP/CP2) and other myeloproliferative disorders, myelodysplastic disorders, acute myelogenous leukemia (CR1), or multiple myeloma (not eligible to receive total body irradiation due to prior radiation) are treated with high dose busulfan and cyclophosphamide followed by allogeneic bone marrow transplantation (BMT). Patients receive oral busulfan every 6 hours on days -7 to -4 and cyclophosphamide IV over 1 hour on days -3 and -2. Allogeneic bone marrow is infused on day 0.
* Regimen B: Patients with acute myelogenous leukemia (at least CR2, relapsed), acute lymphoid leukemia (ALL), any acute leukemia with CNS involvement, multiple myeloma, or chronic lymphocytic leukemia are treated with total body irradiation and etoposide followed by allogeneic BMT. Patients receive total body irradiation (TBI) on days -7 to -4 for a total of 11 fractions and etoposide IV over 4 hours on day -3. Male patients with ALL receive a testicular boost in 2 fractions on 2 successive days during TBI. Allogeneic bone marrow is infused on day 0.
Patients in both regimens receive cyclosporine and methotrexate as graft versus host disease prophylaxis.
Patients are followed weekly for 3 months and then monthly for 1 year.
PROJECTED ACCRUAL: At least 50 patients with low risk myeloid disease, 50 patients with lymphoid malignancies, and 60 patients with high risk myeloid disease will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 125
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VP16/TBI Fractionated Total Body Irradiation (FTBI) Fractionated Total Body Irradiation + VP-16 BuCy2 busulfan Busulfan \& Cyclophosphamide BuCy2 Cyclophosphamide Busulfan \& Cyclophosphamide VP16/TBI VP-16 Fractionated Total Body Irradiation + VP-16
- Primary Outcome Measures
Name Time Method Relapse-free survival 5 years post transplant Relapse free survival 5 post transplant deteremiend by the Kaplan-Meier product-limit method.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
🇺🇸Tampa, Florida, United States