Spots Global Cancer Trial Database for R-CHOP and Alemtuzumab in Patients With Chronic Lymphocytic Leukemia
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Trial Identification
Brief Title: R-CHOP and Alemtuzumab in Patients With Chronic Lymphocytic Leukemia
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
Study ID: NCT00504491
Interventions
Study Description
Brief 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.
Detailed 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
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
ICO Badalona, Badalona, Barcelona, Spain
ICO Bellvitge, Hospitalet de Llobregat, Barcelona, Spain
Althaia, Manresa, Barcelona, Spain
Corporacion Sanitaria Parc Tauli, Sabadell, Barcelona, Spain
Hospital Clinic i Provincial., Barcelona, Cataluña, Spain
Hospital Universitario de Canarias, La Laguna, Gran Canaria, Spain
Hospital de Son Dureta, Palma de Mallorca, Islas Baleares, Spain
Hospital Francisco de Borja, Gandia, Valencia, Spain
Hospital del Mar, Barcelona, , Spain
Hospital Santa Creu i Sant Pau, Barcelona, , Spain
Hospital Valle de Hebron, Barcelona, , Spain
Hospital de Basurto, Bilbao, , Spain
ICO Gerona, Girona, , Spain
Hospital Virgen de las Nieves, Granada, , Spain
Hospital Arnau de Vilanova, Lleida, , Spain
Hospital La Princesa, Madrid, , Spain
Hospital Gregorio Marañon, Madrid, , Spain
M.D.Anderson Internacional, Madrid, , Spain
Hospital Ramón y Cajal, Madrid, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital 12 de octubre, Madrid, , Spain
Hospital Morales Meseguer, Murcia, , Spain
Hospital Clinico de Salamanca, Salamanca, , Spain
Hospital Marques de Valdecilla, Santander, , Spain
Hospital Clinico Universitario de Santiago, Santiago de Compostela, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Hospital Joan XXIII, Tarragona, , Spain
Hospital La Fe, Valencia, , Spain
Hospital Clinico de Valencia, Valencia, , Spain
Hospital Doctor Peset, Valencia, , Spain
Hospital General de Valencia, Valencia, , Spain
Hospital Miguel Servet, Zaragoza, , Spain
Contact Details
Name: Francesc Bosch, MD, PhD
Affiliation: Hospital Clinic of Barcelona
Role: PRINCIPAL_INVESTIGATOR
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