NCT00350181

Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT

Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor Hematopoietic Cell Transplantation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 2 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

GVHD prophylaxis of sirolimus and mycophenolate mofetil for patients undergoing matched related allogeneic transplant for acute and chronic leukemia, MDS, high risk NHL and HL

Detailed description

To explore the novel combination of sirolimus and mycophenolate mofetil (MMF) as graft versus host disease (GVHD) prevention in HLA matched related donor blood or marrow transplantation (BMT). This study will report the toxicities associated with this drug combination and also explore possible correlations between specific blood cell types and antibody production during this therapy.

Conditions

• Leukemia
• Lymphoma, Non-Hodgkin
• Hematologic Diseases
• Acute GVHD

Interventions

Type	Name	Description
DRUG	Sirolimus	Immunosuppressant beginning day -3 with 12 mg oral loading dose, 4 mg/day orally for adults
DRUG	MMF	Immunosuppressant given through IV on day 0 at 15 mg/kg twice daily ≥ 2hr after the completion for the donor cell infusion
DRUG	BCNU	15 mg/kg, IV
DRUG	VP-16	60 mg/kg, IV
DRUG	CY	For subjects aged 18-60 with lymphoma 100 mg/kg, IV For subjects aged with AML, ALL or CML 18-50 60 mg/kg, IV For subjects aged 51-60 with MDS, AML or ALL or patients age 18-60 with MDS, secondary AML or non-CML myeloproliferative disease 45 mg/kg
DRUG	FTBI	1320 cGy delivered in 11 120 cGy fractions over 4 day
DRUG	BU	BU 1 mg/kg every 6hr x 4 doses, IV

Timeline

• Start date: 2006-08-01
• Primary completion: 2007-08-01
• Completion: 2010-04-01
• First posted: 2006-07-10
• Last updated: 2021-09-23

Locations

1 site across 1 country: United States