MAINTENANCE TREATMENT WITH ALEMTUZUMAB Campath AS AN ALTERNATIVE TO ALLOGENIC TRANSPLANTATION IN PATIENTS WITHOUT COMPATIBLE DONOR IN PATIENTS WITH PERIPHERAL T CELL LYMPHOMA - ND

• Conditions: patients with Perpheral T cell Lymphoma; MedDRA version: 6.1Level: HLGTClassification code 10025321

• Registration Number: EUCTR2006-001164-24-IT
• Lead Sponsor: G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-08-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

- Histologically confirmed diagnosis of Peripheral T cell Lymphoma Entheropathy-type T-cell Lymphoma; Hepatosplenic T-cell Lymphoma; Subcutaneous Panniculitis-like T-cell Lymphoma; Angioimmunoblastic T-cell Lymphoma; Peripheral T-cell Lymphoma, unspecified - Stage I IV - Performance Status ECOG 0 3 - Age 18 65 years - CD52 positivity - Previous induction therapy with CHOP or DHAP, followed by autologous bone marrow transplantion - Complete or partial 75 response at the time of inclusion into the study - HIV, HbsAg, HCV negativity - CMV Ag and/or Ab anti CMV IgM negativity - ANC 1.500 x 109/L and PLT 75 x 109/L - Normal renal and hepatic functions - LVEF 50 - Documented absence of infections - No previous or concomitant neoplasms - No CNS involvement - Use of effective contraception - Negative pregnancy test - Written Informed Consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Cardiopathy- LVEF 40 - No previous treatment - Myelodysplasic syndromes - HbsAg, HIV and HCV-RNA positivity

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: to assess the efficacy of Campath as maintenance therapy in T cell lymphomas, after induction therapy with chemotherapy followed by autologous bone marrow transplantation, in terms of progression free survival;Secondary Objective: to assess overall survival, response duration and toxicity;Primary end point(s): progression free survival