R-CHOP and Alemtuzumab in Patients With Chronic Lymphocytic Leukemia
Status:
Withdrawn
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
CABYC
Collaborators:
Bayer Francesc Bosch, MD Fundacion Clinic per a la Recerca Biomédica Genzyme, a Sanofi Company Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea