Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies

PHASE2CompletedINTERVENTIONAL
Enrollment

303

Participants

Timeline

Start Date

March 31, 2003

Primary Completion Date

April 30, 2014

Study Completion Date

January 31, 2016

Conditions
Blood CancerLeukemia
Interventions
DRUG

Cyclosporine

Starting day -3 at a dose of 5 mg/kg orally twice daily with a target trough level of 350 to 450 ng/mL

DRUG

Anti-thymocyte globulin (ATG)

1.5 mg/kg for total dose of 7.5mg/kg, IV starting on day -11 to day -7 before HCT

DRUG

Mycophenolate mofetil (MMF)

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.

DRUG

Filgrastim

"* Donors mobilized with 16 µg/kg/day filgrastim.~* As needed, myelosuppression in transplant recipients will be managed with subcutaneous filgrastim 5 µg/kg/day"

RADIATION

Total Lymphoid Irradiation (TLI)

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.

Trial Locations (1)

94305

Stanford University School of Medicine, Stanford

All Listed Sponsors
lead

Stanford University

OTHER

NCT00185640 - Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies | Biotech Hunter | Biotech Hunter