A Phase II Study of Dose Augmented Rituximab and Ice for Patients With Primary Refractory and Poor Risk Relapsed Aggressive B-Cell Non-Hodgkin's Lymphoma Undergoing Second-Line Therapy Prior to Stem Cell Transplantation
The purpose of this study is to determine if dose escalation of the rituximab-ICE (RICEesc)
program can improve the overall response rate of patients with primary refractory or poor
risk relapsed aggressive B cell lymphoma. R-ICEesc will be administered for 2 cycles with
peripheral blood progenitor cells (PBPCs) collected after cycle 2.
A two-stage design will be employed, such that the study will be terminated if in the first
cohort of patients it appears that the overall response rate is <50% or if >25% patients
fail to mobilize at least 2 x 106 CD34+ cells/kg.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To assess the ability R-ICEesc chemotherapy to improve the overall response rate in primary refractory or poor risk relapsed aggressive B cell lymphoma patients from 50% to 70%
Craig Moskowitz, MD
Memorial Sloan-Kettering Cancer Center
United States: Institutional Review Board
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