Conditions: Blood Cancer Leukemia
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 303
Healthy volunteers: no

Brief summary:
To measure how frequently and to what degree a complication of transplant cell acute graft versus host disease (GvHD) occurs.

Detailed description:
This study evaluated whether TLI-ATG conditioning followed by allogeneic hematpoietic cell transplant (HCT), which has provided excellent overall survival for patients with relapsed lymphoma after failed autologous HCT, provides a similar benefit in the setting of elderly patients with hematologic malignancies.

Arms:
arm 1: Pre-transplant total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG) infusion with Day 0 allogeneic hematopoietic cell transplant (HCT), followed by post-transplant immunosuppression by cyclosporine and mycophenolate mofetil.

Interventions: intervention 1: Cyclosporine intervention 2: Anti-thymocyte globulin (ATG) intervention 3: Mycophenolate mofetil (MMF) intervention 4: Filgrastim intervention 5: Total Lymphoid Irradiation (TLI)
Intervention descriptions: intervention 1: Starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL intervention 2: 1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT intervention 3: Begins on day 0 after HCT at a dose of 15 mg/kg. Transplant recipients who received related donor grafts received MMF twice daily and those who received unrelated donor grafts received MMF 3 times daily. intervention 4: * Donors mobilized with 16 µg/kg/day filgrastim.
* As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day intervention 5: 0.8 Gy/day from day -11 to day -7 (inclusive) from day -4 to day -2 (inclusive) with 2 additional fractions of 0.8 Gy delivered on day -1 for total dose of 8 Gy.

Protocol document: