NCT00185640

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

Allogeneic Hematopoietic Cell Transplantation Using a Non-Myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Older Patients With Hematologic Malignancies

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Blood Cancer
• Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2003-03-01
• Primary completion: 2014-04-01
• Completion: 2016-01-01
• First posted: 2005-09-16
• Last updated: 2021-06-29
• Results posted: 2017-10-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study