R-CHOP and Alemtuzumab in Patients With Chronic Lymphocytic Leukemia — R-CHOP  

Chronic Lymphocytic Leukaemia Clinical Trial

Official title: Rescue Treatment With Rituximab-CHOP Therapy and Alemtuzumab (R-CHOP-A) in Refractory or Recidivant Patients With Chronic Lymphocytic Leukemia After Purine-analogous Treatment

Status Withdrawn

Clinical Trial Summary

Since there is no standard rescue therapy for refractory CLL or relapsed to the purine analogous, our target is to carry out a rescue therapy combining several chemotherapy agents (CHOP) adding the synergistic effect of Rituximab in order to act against tumour-like CLL forms, with assessable size lymph nodes. Afterwards, based in other studies, we shall study the role of Alemtuzumab as drug for consolidation or improvement of responses obtained with the initial therapy (CHOP-R), acting by "cleaning" from peripheral blood and bone marrow the CLL lymphocytes that may have had remain as residual after chemotherapy induction therapy. More precisely, the addition of Alemtuzumab as maintenance treatment would increase the complete responses with negative residual disease number and may prolong the duration of the response. For this, it is necessary to have not only an adequate and rigorous clinical follow-up but also biological, i.e. being able to analyze minimal residual disease by molecular biology techniques. This is the reason of writing this phase II clinical trial protocol.

Clinical Trial Description

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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukaemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Patients Relapsed With Purines Therapy
• Patients Resistant to a Purine Analogous

• NCT number: NCT00504491
• Study type: Interventional
• Source: CABYC
• Status: Withdrawn
• Phase: Phase 2
• Start date: July 2007
• Completion date: June 2012