Conditions: Leukemia, Mast-Cell Mantle-cell Lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 36
Healthy volunteers: no

Brief summary:
To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)

Detailed description:
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).

Arms:
arm 1: Rituximab will be infused after a non-myeloablative transplantation regimen of total lymphoid irradiation (TLI) + anti-thymoglobulin (ATG), with the intention of reducing chronic graft-vs-host disease (cGvHD)

Interventions: intervention 1: Total lymphoid irradiation intervention 2: Rituximab intervention 3: Anti-thymoglobulin, rabbit (ATG, rabbit ATG) intervention 4: Cyclosporine intervention 5: Mycophenylate mofetil intervention 6: Filgrastim intervention 7: Granisetron intervention 8: Solumedrol intervention 9: Acetaminophen intervention 10: Diphenhydramine intervention 11: Hydrocortisone
Intervention descriptions: intervention 1: Total lymphoid irradiation (TLI) administered at 80cGy for 10 days intervention 2: Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses. intervention 3: 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. intervention 4: 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). intervention 5: Mycophenylate mofetil (MMF) will be administered at 15 mg/kg po Day 0, at 5 to 10 hours after mobilized PBPC infusion is complete intervention 6: Filgrastim provided as needed for neutrophil support intervention 7: Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI intervention 8: Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG) intervention 9: Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC intervention 10: Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC intervention 11: Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC

Protocol document: