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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Treatments: Alemtuzumab; Immunologic Factors

Criteria

Inclusion Criteria:

• Age ≥18 <60 years (patients older than 60 years are excluded because of the intensive chemotherapy and transplant procedures)

• 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

Exclusion Criteria:

• Histological PTCL subset other than PTCL-U, AILD-T ALCL-ALKneg, 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 hypersensitivity or anaphylactic reactions to proteins drugs

• Active secondary malignancy