Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of CGVHD

Part of paid clinical trials in Stanford, California.

Sponsor
Stanford University
Study ID
NCT00186628
Phase
PHASE2
Status
Completed

Conditions

  • Leukemia, Mast-Cell
  • Mantle-cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 76 Years
Healthy Volunteers
Not accepted

Interventions

  • Total lymphoid irradiation — PROCEDURE
    Total lymphoid irradiation (TLI) administered at 80cGy for 10 days
  • Rituximab — DRUG
    Rituximab 375 mg/m2 administered as an intravenous (IV) infusion once weekly for 4 doses.
  • Anti-thymoglobulin, rabbit (ATG, rabbit ATG) — DRUG
    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.
  • Cyclosporine — DRUG
    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 — DRUG
    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 — DRUG
    Filgrastim provided as needed for neutrophil support
  • Granisetron — DRUG
    Granisetron administered as an anti-nausea agent (anti-emetic) at 1 mg orally 30 to 60 minutes before TLI
  • Solumedrol — DRUG
    Solumedrol, an anti-inflammatory glucocorticoid containing methylprednisolone sodium succinate, administered at 1 mg/kg as a premedication for anti-thymoglobulin (ATG)
  • Acetaminophen — DRUG
    Acetaminophen administered orally at 650 mg 1 hour prior to infusion of PBPC
  • Diphenhydramine — DRUG
    Diphenhydramine administered by intravenous infusion at 50 mg 1 hour prior to infusion of PBPC
  • Hydrocortisone — DRUG
    Hydrocortisone administered by intravenous infusion at 100 mg 1 hour prior to infusion of PBPC

Study Details

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

Key Dates

Start date
Jun 30, 2005
Status verified
Oct 2017
Primary completion
Nov 30, 2010
Completion
Dec 31, 2010

Study Design

Enrollment
36 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Prophylactic Rituximab
    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)

Primary Outcome Measure

Chronic Graft-vs-Host Disease (cGvHD) [ Time Frame: 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-

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By research site
Stanford University School of Medicine· Stanford, CA

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