A Phase II Study Evaluating Three Cyslces of Ifosfamide, Carboplatin, Etoposide, and Rituximab (RICE) Followed by Two Cycles of Gallium Nitrate, Rituximab and Dexamethasone (GARD) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma MA
This is a Phase 2 trial evaluating the efficacy of adding the combination of GaRD x 2 cycles
following 3 cycles of the standard salvage regimen of RICE for the treatment of relapsed or
refractory diffuse, large B-cell lymphoma (DLBCL). The study will include patients who have
relapsed after 1 prior treatment regimen or who are refractory to initial chemotherapy. We
will evaluate patients for response rate (both partial and complete), toxicities, as well as
overall and progression free survival. Eligible patients will receive standard RICE x 3
cycles followed by GaRD x 2 cycles. Patients who would otherwise be eligible, may then
proceed to autologous stem cell transplant (ASCT).
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine CR rates of standard salvage chemotherapy with rituximab, ifosfamide, carboplatin and etoposide (RICE) for relapsed/refractory diffuse aggressive NHL followed by a novel regimen of gallium nitrate, rituximab, and dexamethasone (GARD)
12 weeks
No
Scott Smith, MD, PhD, FACP
Principal Investigator
Loyola University
United States: Institutional Review Board
200119
NCT00836173
July 2008
May 2012
Name | Location |
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Loyola Univeristy Medical Center, Cardinal Bernardin Cancer Center | Maywood, Illinois 60153 |