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Clinical Trial Summary

Phase II, multicenter, randomized trial, exploring intensified Rituximab prephase monotherapy before standard Fludarabine-Cyclophosphamide-Rituximab FC-R regimen in previously untreated symptomatic B-cell chronic lymphocytic leukemia CLL.

A Study from the Goelams GCFLLCMW intergroup


Clinical Trial Description

Young fit medically B Cell untreated patients Comparison between FCR treatment = 6 FCR cycles and a the addition of a prephase with R Dense treatment before the 6 FCR cycles. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms

  • B-cell Chronic Lymphocytic Leukemia CLL
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid

NCT number NCT01370772
Study type Interventional
Source French Innovative Leukemia Organisation
Contact
Status Completed
Phase Phase 2
Start date May 2011
Completion date March 2016