study to evaluate the efficacy of a preparative regimen for transplantation in refractory/relapsed non-Hodgkin lymphoma patients.

• Conditions: Adult agressive B-cell non-Hodgkin lymphoma patients.; MedDRA version: 14.1Level: PTClassification code 10012821Term: Diffuse large B-cell lymphoma recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.1Level: SOCClassification code 10005329Term: Blood and lymphatic system disordersSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]; MedDRA version: 14.1Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; MedDRA version: 14.1Level: PTClassification code 10012822Term: Diffuse large B-cell lymphoma refractorySystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2011-001246-14-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-16
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Aggressive B-Cell non-Hodgkin lymphoma patients either resistant or relapsed
• Age >18 and <70 years
• Signed Informed Consent
• Karnofsky score > 70%
•Adequate hematologic, renal, pulmonary and hepatic function.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

• HIV infection
• HCV positivity
•Secondary lymphoma following prior chemotherapy/ radiotherapy or an
active second malignancy
• Pregnancy or nursing
•Absence of patient’s written informed consent
• Current uncontrolled infections
•Intercurrent organ damage or medical problems that would interfere with therapy

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 1-year complete remission (CR) rate.;Secondary Objective: • To assess the safety of the regimen<br>• To assess the disease-free survival<br>• To assess the overall survival;Primary end point(s): To assess the 1-year complete remission (CR) rate.;Timepoint(s) of evaluation of this end point: 1-year

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • To assess the safety of the regimen<br>• To assess the disease-free survival<br>• To assess the overall survival;Timepoint(s) of evaluation of this end point: 100 days (safety)<br>3-years (event-free and overall survival).