Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced Hematologic Cancer
- Conditions
- Myelodysplastic SyndromesLeukemia
- Interventions
- Procedure: allogeneic bone marrow transplantationProcedure: allogeneic hematopoietic stem cell transplantationProcedure: peripheral blood stem cell transplantationRadiation: total-body irradiation
- Registration Number
- NCT00534430
- Lead Sponsor
- City of Hope Medical Center
- Brief Summary
RATIONALE: Giving chemotherapy and total-body irradiation before a donor stem cell transplant or a donor bone marrow transplant helps stop the growth of cancer and abnormal cells and 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. Giving mycophenolate mofetil and cyclosporine before and after transplant may stop this from happening.
PURPOSE: This phase II trial is studying the side effects and best way to give busulfan together with etoposide and total-body irradiation and to see how well they work in treating patients who are undergoing a donor stem cell or bone marrow transplant for advanced hematologic cancer.
- Detailed Description
OBJECTIVES:
* To determine the efficacy of a preparative regimen comprising dose targeted busulfan, etoposide, and fractionated total-body irradiation followed by allogeneic hematopoietic stem cell or bone marrow transplantation in patients with advanced hematologic malignancies.
* To determine the efficacy of this regimen in patients with acute myeloid leukemia in first remission with unfavorable cytogenetics.
* To evaluate the early and late toxicities of this regimen.
OUTLINE:
* Preparative chemotherapy regimen: Patients receive busulfan IV over 2 hours once every 6 hours on days -14 to -8 for a total of 16 doses and etoposide IV on day -3.\* NOTE: \*Patients also receive oral or IV dilantin 1-3 times daily on days -18 to -5 for prophylaxis of grand mal seizures.
* Fractionated total-body irradiation (FTBI): Patients undergo FTBI on days -7 to -4 for a total of 10 fractions.
* Allogeneic transplantation: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0.
* Graft-versus-host disease (GVHD) prophylaxis: Patients receive cyclosporine IV or orally on days -1 to 50 followed by a taper to day 180 in the absence of GVHD. Patients also receive mycophenolate mofetil orally or IV over 2 hours twice daily on days 0-27, followed by a taper until day 56.
After completion of study treatment, patients are followed annually for 2 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Busulfan, FTBI and VP16 cyclosporine IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant Busulfan, FTBI and VP16 allogeneic bone marrow transplantation IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant Busulfan, FTBI and VP16 allogeneic hematopoietic stem cell transplantation IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant Busulfan, FTBI and VP16 peripheral blood stem cell transplantation IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant Busulfan, FTBI and VP16 total-body irradiation IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant Busulfan, FTBI and VP16 busulfan IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant Busulfan, FTBI and VP16 etoposide IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant Busulfan, FTBI and VP16 mycophenolate mofetil IV Busulfan + 12 cGy FTBI + VP16 prior to allogeneic Bone Marrow Transplant
- Primary Outcome Measures
Name Time Method Overall Survival at 5 Years Post-Transplant. Date of Transplant to Five Years post-Transplant Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%.
Disease-free Survival at Five Years Post-transplant Date of transplant to five years post-transplant Kaplan-Meier estimate of an event of relapse or death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%.
Overall Survival Comparing Diagnosis Groups Date of Transplant to Five Years post-Transplant Kaplan-Meier estimate of an event of death estimated at five years post-transplant. 95% confidence intervals were calculated from the logit transform of the Greenwood variance. The transformation was necessary to keep the estimate within the probability space of 0 to 100%.
Cumulative Incidence of Relapse With Transplant-related Death as the Competing Risk: Diagnosis Groups Are Compared. Date of Transplant to Five Years post-Transplant. Estimate is at Five Years post-Transplant. Fine and Gray estimate of cumulative incidence of Relapse, with Death as the competing risk. Estimate is at five years post-transplant. Ninety-five percent confidence interval is by logit transformation of Greenwood variance to keep the interval within the probability space of 0% to 100%.
- Secondary Outcome Measures
Name Time Method