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

PHASE2CompletedINTERVENTIONAL
Enrollment

11

Participants

Timeline

Start Date

August 31, 2006

Primary Completion Date

August 31, 2007

Study Completion Date

April 30, 2010

Conditions
LeukemiaLymphoma, Non-HodgkinHematologic DiseasesAcute GVHD
Interventions
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

Trial Locations (1)

94305

Stanford University School of Medicine, Stanford

All Listed Sponsors
lead

Stanford University

OTHER

NCT00350181 - Sirolimus & Mycophenolate Mofetil as GVHD Prophylaxis in Myeloablative, Matched Related Donor HCT | Biotech Hunter | Biotech Hunter