At a glance
ClinicalIndex Comparison Record- ✓Chronic lymphocytic leukemia (CLL) with unmutated or mutated IgG VH genes, or mantle cell lymphoma (MCL) where transplant physicians believe patient would benefit from allogeneic HSCT
- ✓Age 18-76 years old
- ✓HLA-identical or nearly identical donor (9 of 10 or phenotypically matched); donor must be capable of G-CSF mobilization and apheresis
- ✓Adequate renal function (creatinine <2.4 mg/dL)
- ✕HLA 9 of 10 or 10 of 10 identical donor (high resolution molecular genotyping)
- ✕Pregnancy or lactation
- ✕Serious uncontrolled infection, HIV seropositivity, or hepatitis B or C seropositivity
- ✕Cardiac ejection fraction <40% or uncontrolled cardiac failure
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label, Phase 2 Trial of Prophylactic Rituximab Therapy for Prevention of Chronic Graft Versus Host Disease After TLI/ARG Nonmyeloablative Allogeneic Stem Cell Transplantation
In Brief
A Phase 2 clinical trial evaluating Total lymphoid irradiation, Rituximab, and 9 other interventions for Leukemia, Mast-Cell and Mantle-cell Lymphoma. Completed, enrolled 36 participants across 1 site.
Detailed Summary
To determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cGvHD)
Study Details
Timeline
Interventions
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.
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