A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation

PHASE1CompletedINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

May 16, 2008

Primary Completion Date

July 5, 2012

Study Completion Date

October 16, 2013

Conditions
Graft vs Host DiseasePeripheral Blood Stem Cell TransplantationTransplantation, Homologous
Interventions
DRUG

Tacrolimus

Tacrolimus as a continuous IV infusion will begin on day -3. (Levels will be monitored at least every 3 days to target 5-10 ng/mL)

DRUG

Sirolimus

Sirolimus oral loading dose on day -3, followed by oral daily dose. (Levels will be monitored at least every 3 days to target 3-12 ng/mL)

DRUG

Bortezomib

"Administered intravenously on day 0 (a minimum of 6 hours post-infusion of PBSC), and on day +3. The following dose levels will be used:~Cohort 1 (3-6 pts): 1 mg/m2 on days 0 and +3~Cohort 2 (3-6 pts): 1.3 mg/m2 on days 0 and +3~Cohort 3 (3-10 pts): 1.6 mg/m2 on days 0 and +3"

Trial Locations (1)

46202

Indiana University Melvin and Bren Simon Cancer Center, Indianapolis

Sponsors
All Listed Sponsors
collaborator

Millennium Pharmaceuticals, Inc.

INDUSTRY

lead

Jennifer E. Schwartz

OTHER

NCT00670423 - A Study Using Tacrolimus, Sirolimus and Bortezomib as Acute Graft Versus Host Disease (GVHD) Prophylaxis in Allogeneic Peripheral Blood Stem Cell (PBSC) Transplantation | Biotech Hunter | Biotech Hunter