Phase II multicentric study to evaluate the efficacy and the safety of Bendamustine in adjunct to Etoposide, Aracytabin and Melphalan (BeEAM) as a preparative regimen for autologous stem cell transplantation in refractory/relapsed lymphoma patients. - BeEAM

• Conditions: Diagnosis of Non-Hodgkin lymphoma of any subtype, chronic lymphocytic leukemia, or Hodgkin disease either refractory or relapsed after at least one line of chemotherapy.; MedDRA version: 9.1Level: HLGTClassification code 10025320; MedDRA version: 9.1Level: HLGTClassification code 10025319

• Registration Number: EUCTR2008-002736-15-IT
• Lead Sponsor: AZIENDA OSPEDALIERA OSPEDALE S. SALVATORE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Diagnosis of Non-Hodgkin lymphoma of any subtype, chronic lymphocytic leukemia, or Hodgkin disease either refractory or relapsed after at least one line of chemotherapy. Age ≥ 18 and ≤ 65 years. Signed Informed Consent. Karnofsky score > 70% or WHO ≤ 1. Adequate hematologic, renal, pulmonary and hepatic function.
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

HIV infection. 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 3 years event free survival of lymphoma patients submitted to BeEAM chemotherapy followed by the reinfusion of autologous hematopoietic stem cells.;Secondary Objective: To assess the safety of BeEAM chemotherapy followed by the reinfusion of autologous hematopoietic stem cells by considering the incidence of adverse event (graded according to WHO) and clinically significant abnormal laboratory values following reinfusion. To assess the percentage of patients entering complete remission (CR). To assess the overall survival of resistant or relapsed lymphoma patients exposed to BeEAM chemotherapy followed by the reinfusion of autologous hematopoietic stem cells as salvage treatment. To assess transplant-related toxicity.;Primary end point(s): To assess the 3 years event free survival of lymphoma patients submitted to BeEAM chemotherapy followed by the reinfusion of autologous hematopoietic stem cells.