Intensive chemo-immunotherapy as first-line treatment in adult patients with peripheral T-cell Lymphoma PTCL - PTCL intensive chemo-immunotherapy

Conditions: on Hodgkin peripheral T-cell lymphomas
MedDRA version: 6.1Level: PTClassification code 10034623

Registration Number: EUCTR2006-004234-33-IT

Lead Sponsor: ISTITUTO NAZIONALE PER LA CURA TUMORI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 111

Inclusion Criteria

Age 18 and 60 years for Study A patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures and 60 and 75 years for Study B patients older than 75 years are excluded because of the intensive chemo-immunotherapy program Histologically proven diagnosis of PTCL, including the following categories PTCL-U peripheral T-cell lymphoma, unspecified , AILD-T angioimmunoblastic-like T-cell lymphoma , ALKneg ALCL ALK-negative anaplastic large cell lymphoma ,intestinal T - NHL Advanced stage disease stage II-IV or stage I and aaIPI score 2 Written informed consent CD52 expression on neoplastic cells
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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Histological PTCL subset other than PTCL-U, AILD-T, ALKneg-ALCL, intestinal T - NHL Central nervous system localization Positive serologic markers for human immunodeficiency virus HIV , hepatitis B virus HBV , and hepatitis C virus HCV infection Serum bilirubin levels 2 the upper normal limit Clearance of creatinine 50 ml/min DLCO 50 Ejection fraction 45 or myocardial infarction in the last 12 months Pregnancy or lactation Patient not agreeing to take adequate contraceptive measures during the study Psychiatric disease Any active, uncontrolled infection Type I hypersensivity or anaphylactic reactions to proteins drugs Active secondary malignancy

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy ie complete clinical response at one year of an intensified chemo-immunotherapy program in patients with PTCL;Secondary Objective: Overall survival Disease free-survival Treatment related mortality;Primary end point(s): Efficacy of innovative therapies in non Hodgkin peripheral T-cell lymphomas

Secondary Outcome Measures