Rescue Treatment With Rituximab-CHOP Therapy and Alemtuzumab (R-CHOP-A) in Refractory or Recidivant Patients With Chronic Lymphocytic Leukemia After Purine-analogous Treatment
OBJECTIVES
The objectives of this clinical trial are the following:
- Main objective of the study: Overall response rate obtained after R-CHOP regime
followed by Alemtuzumab consolidation as second line therapy
- Secondary objectives
- Determine the molecular complete response rate after R-CHOP regimen
- Determine the efficacy of Alemtuzumab in response improvement after R-CHOP
regimen: conversion of PR to CR and of MRD+ to MRD-.
- Applicability (toxicity profile) of Alemtuzumab consolidation therapy.
- As additional objectives will be considered:
1. Prognostic value of several biological variables (ZAP-70 and cytogenetics)
having influence on the response
2. Response duration
3. Progression free survival
4. Overall survival
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response rate obtained after R-CHOP regimen followed by consolidation therapy with Alemtuzumab, as second line therapy. Haematological and non haematological toxicity will be graded in accordance with the WHO system
57 months
Francesc Bosch, MD, PhD
Principal Investigator
Hospital Clinic de Barcelona
Spain: Spanish Agency of Medicines
GELLC-2
NCT00504491
July 2007
June 2012
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