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R-CHOP and Alemtuzumab in Patients With Chronic Lymphocytic Leukemia

NCT00504491 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2011-12-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Rituximab-CHOP-Alemtuzumab

Four Rituximab - CHOP courses will be given The courses will be given every 21 days

Sponsors & Collaborators

  • Francesc Bosch, MD

    collaborator UNKNOWN

  • Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

    collaborator OTHER

  • Fundacion Clinic per a la Recerca Biomédica

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • CABYC

    lead INDUSTRY

Principal Investigators

  • Francesc Bosch, MD, PhD · Hospital Clinic of Barcelona

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2012-01-31
Completion
2012-06-30

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00504491 on ClinicalTrials.gov