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Sponsors and Collaborators: |
CABYC Francesc Bosch, MD Fundacion Clinic per a la Recerca Biomédica |
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Information provided by: | CABYC |
ClinicalTrials.gov Identifier: | NCT00504491 |
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.
Condition | Intervention | Phase |
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Chronic Lymphocytic Leukaemia Patients Resistant to a Purine Analogous Patients Relapsed With Purines Therapy |
Drug: Rituximab-CHOP-Alemtuzumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 60 |
Study Start Date: | July 2007 |
Estimated Study Completion Date: | June 2012 |
Arms | Assigned Interventions |
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1: Experimental
Four Rituximab – CHOP courses will be given The courses will be given every 21 days Drug Dose Day Rituximab (Mabthera) 500mg/m2 1(*) (**) Cyclophosphamide 750mg/m2 1 Adriamycin 50mg/m2 1 Vincristine 1,4 mg/m2 1 Prednisone 60mg/m2 1 to 5 (**) 1st course, 375 mg/m2 (*) If lymphocyte count is > 30 X 10 9/l, dose will be split up in two, which will be given in days 0 and 1 |
Drug: Rituximab-CHOP-Alemtuzumab
Four Rituximab – CHOP courses will be given The courses will be given every 21 days
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1 OBJECTIVES
The objectives of this clinical trial are the following:
1.1 Main objective of the study
Overall response rate obtained after R-CHOP regime followed by Alemtuzumab consolidation as second line therapy
1.2 Secondary objectives
As additional objectives will be considered:
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Active CLL defined by the presence of one or more of the following criteria:
Patients previously treated in first line with purine analogous and showing:
Exclusion Criteria:
Contact: Felipe Yunta, PhD | +34 916 590 433 | felipe.yunta@cabyc.com |
Contact: Jorge Enrique Diaz, MD | +34 916 590 433 | jorge.diaz@cabyc.com |
Spain | |
Hospital Santa Creu i Sant Pau | |
Barcelona, Spain, 08025 | |
Hospital del Mar | |
Barcelona, Spain, 08003 | |
Hospital Valle de Hebron | |
Barcelona, Spain, 08035 | |
Hospital de Basurto | |
Bilbao, Spain, 48013 | |
ICO Gerona | |
Girona, Spain, 17007 | |
Hospital Virgen de las Nieves | |
Granada, Spain, 18014 | |
Hospital Arnau de Vilanova | |
Lleida, Spain, 25198 | |
Hospital 12 de octubre | |
Madrid, Spain, 28041 | |
Hospital Clinico de Salamanca | |
Salamanca, Spain, 37007 | |
Hospital La Princesa | |
Madrid, Spain, 28006 | |
Hospital Ramón y Cajal | |
Madrid, Spain, 28034 | |
Hospital Clínico San Carlos | |
Madrid, Spain, 28040 | |
Hospital Gregorio Marañon | |
Madrid, Spain, 28007 | |
Hospital Morales Meseguer | |
Murcia, Spain, 30008 | |
Hospital Morales Meseguer | |
Murcia, Spain, 30008 | |
M.D.Anderson Internacional | |
Madrid, Spain, 28033 | |
Hospital Marques de Valdecilla | |
Santander, Spain, 39008 | |
Hospital Clinico Universitario de Santiago | |
Santiago de Compostela, Spain, 36680 | |
Hospital Joan XXIII | |
Tarragona, Spain, 43005 | |
Hospital General de Valencia | |
Valencia, Spain, 46018 | |
Hospital Clinico de Valencia | |
Valencia, Spain, 46011 | |
Hospital Virgen del Rocio | |
sevilla, Spain, 41013 | |
Hospital La Fe | |
Valencia, Spain, 46009 | |
Hospital Miguel Servet | |
Zaragoza, Spain, 50009 | |
Hospital Doctor Peset | |
Valencia, Spain, 46017 | |
Spain, Barcelona | |
ICO Badalona | |
Badalona, Barcelona, Spain, 08916 | |
ICO Bellvitge | |
Hospitalet de Llobregat, Barcelona, Spain, 08907 | |
Corporacion Sanitaria Parc Tauli | |
Sabadell, Barcelona, Spain, 08208 | |
Althaia | |
Manresa, Barcelona, Spain, 08243 | |
Spain, Cataluña | |
Hospital Clinic i Provincial. | |
Barcelona, Cataluña, Spain, 08036 | |
Spain, Gran Canaria | |
Hospital Universitario de Canarias | |
La Laguna, Gran Canaria, Spain, 38320 | |
Spain, Islas Baleares | |
Hospital de Son Dureta | |
Palma de Mallorca, Islas Baleares, Spain, 07014 | |
Spain, Valencia | |
Hospital Francisco de Borja | |
Gandia, Valencia, Spain, 46700 |
Principal Investigator: | Francesc Bosch, MD, PhD | Hospital Clinic de Barcelona |
Study ID Numbers: | GELLC-2 |
Study First Received: | July 19, 2007 |
Last Updated: | July 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00504491 History of Changes |
Health Authority: | Spain: Comité Ético de Investigación Clínica; Spain: Spanish Agency of Medicines |
Rituximab-CHOP Alemtuzumab Chronic lymphocytic leukaemia |
Leukemia, Lymphoid Immunoproliferative Disorders Immunologic Factors Rituximab Leukemia Lymphatic Diseases Chronic Lymphocytic Leukemia |
Leukemia, Lymphocytic, Chronic, B-Cell Alemtuzumab Leukemia, B-Cell Lymphoproliferative Disorders Leukemia, B-cell, Chronic Antirheumatic Agents |
Leukemia, Lymphoid Neoplasms by Histologic Type Immunoproliferative Disorders Immune System Diseases Immunologic Factors Antineoplastic Agents Rituximab Physiological Effects of Drugs Pharmacologic Actions |
Leukemia Lymphatic Diseases Neoplasms Leukemia, Lymphocytic, Chronic, B-Cell Therapeutic Uses Alemtuzumab Antirheumatic Agents Leukemia, B-Cell Lymphoproliferative Disorders |