Intensive Chemo-immunotherapy as First Line Treatment in Adult Patients With Peripheral T- Cell Lymphoma
Status:
Completed
Trial end date:
2012-08-01
Target enrollment:
Participant gender:
Summary
Peripheral T cell lymphomas (PTCL) are a rare hematologic disease. Five-year overall survival
(OS) of PTCL patients (pts) ranges between 20 and 30%. Allogeneic stem cell transplantation
(allo-STC) may have a curative role for these pts but its toxicity is high when myeloablative
conditioning is used. Reduced intensity conditionings (RIC) can decrease transplant related
toxicity and mortality. The investigators have recently proved feasibility and potential
efficacy of a RIC regimen in relapsed PTCL patients.
We want to investigate whether it is possible to improve the outcome of alk negative PTCL
pts, stage II-IV at diagnosis, by intensifying the therapeutic approach.
The intensification will be obtained by combining intensive chemotherapy, alemtuzumab
(anti-CD52 humanised antibody) and auto- or allo-SCT in pts aged between 18 and 60 years
(Clinical Study A) or adding alemtuzumab to standard chemotherapy (CHOP) in pts aged between
61 and 70 years(Clinical Study B).
Phase:
Phase 2
Details
Lead Sponsor:
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano