To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
To test if prophylactic anti-B-cell therapy (weekly rituximab) given within 60 to 90 days after allogeneic transplantation will decrease allogeneic donor B-cell immunity and possibly the incidence of chronic graft-vs-host disease (cGvHD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
Total lymphoid irradiation (TLI) administered at 80cGy for 10 days
Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses.
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.
Stanford University School of Medicine
Stanford, California, United States
Chronic Graft-vs-Host Disease (cGvHD)
The cumulative percentage of participants who develop chronic graft-vs-host disease (cGvHD). Chronic cGvHD was defined as at least one instance of a clinically-accepted marker for cGvHD (see Filipovich, et al. Biology of Blood and Marrow Transplantation. 2005;11:945-955)
Time frame: 4 years
Incidence of Relapse
Subjects who Relapsed following after Allogeneic HSCT
Time frame: 4 years
Mortality
Number of participants who died within 100 days and within 1 year, non-relapse and associated with relapse.
Time frame: Day 100 and 1 year
Overall Survival
Time frame: 4 years
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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).
Mycophenylate mofetil (MMF) will be administered at 15 mg/kg po Day 0, at 5 to 10 hours after mobilized PBPC infusion is complete
Filgrastim provided as needed for neutrophil support
Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI
Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG)
Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC
Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC
Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC