Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

June 30, 2005

Primary Completion Date

November 30, 2010

Study Completion Date

December 31, 2010

Conditions
Leukemia, Mast-CellMantle-cell Lymphoma
Interventions
PROCEDURE

Total lymphoid irradiation

Total lymphoid irradiation (TLI) administered at 80cGy for 10 days

DRUG

Rituximab

Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses.

DRUG

Anti-thymoglobulin, rabbit (ATG, rabbit ATG)

Rabbit anti-thymoglobulin (ATG) administered from Day -11 through Day -7 (5 doses) at 1.5 mg/kg/day, for a total dose of 7.5 mg/kg.

DRUG

Cyclosporine

Cyclosporine (CSP) administered orally at 6.25 mg/kg twice-a-day (BID) from Day -3 until through Day +56 post-peripheral blood progenitor cell (PBPC) infusion. Dose may be adjusted to maintain a therapeutic level of cyclosporine, or in response to renal insufficiency. If at Day +56, chimerism assessment demonstrates \> 40% donor cells in the CD3+ lineage, and the patient is without evidence of GvHD, then cyclosporine taper will begin (6% reduction per week).

DRUG

Mycophenylate mofetil

Mycophenylate mofetil (MMF) will be administered at 15 mg/kg po Day 0, at 5 to 10 hours after mobilized PBPC infusion is complete

DRUG

Filgrastim

Filgrastim provided as needed for neutrophil support

DRUG

Granisetron

Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI

DRUG

Solumedrol

Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG)

DRUG

Acetaminophen

Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC

DRUG

Diphenhydramine

Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC

DRUG

Hydrocortisone

Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC

Trial Locations (1)

94305

Stanford University School of Medicine, Stanford

All Listed Sponsors
collaborator

The Leukemia and Lymphoma Society

OTHER

collaborator

National Cancer Institute (NCI)

NIH

lead

Stanford University

OTHER

NCT00186628 - Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD | Biotech Hunter | Biotech Hunter