PHASE II STUDY OF 90Y-IBRITUMOMAB TIUXETAN AND FOTEMUSTINE ASSOCIATED WITH CYTARABINE ETOPOSIDE MELPHALAN AS CONDITIONING CHEMORADIOIMMUNOTHERAPY IN PATIENTS AFFECTED BY LYMPHOMA (HODGKIN AND NON-HODGKIN) CD20+ REFRACTORY/RELAPSED WITH MINIMAL RESIDUAL PERSISTANT DISEASE PRE-AUTOLOGOUS TRANSPLANT - Z-FEAM

Conditions: PATIENTS <= 65 YEARS AFFECTED BY LYMPHOMA (HODGKIN AND NON-HODGKIN) CD20+ REFRACTORY/RELAPSED WITH MINIMAL RESIDUAL PERSISTANT DISEASE PRE-AUTOLOGOUS TRANSPLANT
MedDRA version: 9.1Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cell
MedDRA version: 9.1Level: HLGTClassification code 10025319Term: Lymphomas Hodgkin's disease

Registration Number: EUCTR2008-006899-30-IT

Lead Sponsor: ISTITUTI FISIOTERAPICI OSPITALIERI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

PATIENTS <= 65 YEARS AFFECTED BY LYMPHOMA (HODGKIN AND NON-HODGKIN) CD20+ REFRACTORY/RELAPSED WITH MINIMAL RESIDUAL PERSISTANT DISEASE PRE-AUTOLOGOUS TRANSPLANT
KARNOFSKY PERFORMANCE STATUS >= 70
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

SECOND CONCOMITANT NEOPLASM
HIV SEROPOSITIVITY

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: TO ESTABILISH FACTIBILITY AND SAFETY OF Z-FEAM BY ASSESSMENT:<br>1. HEMATOLOGICAL AND EXTRA-HEMATOLOGICAL TOXICITY<br>2. TRANSPLANT RELATED MORTALITY<br>3. MYELOID RECOVERY<br>4. IMMUNOLOGICAL RECONSTITUTION;Secondary Objective: TREATMENT EFFICACY IN TERMS OF:<br>1. COMPLETE RESPONSE<br>2. PROGRESSION FREE SURVIVAL<br>3. EVENT FREE SURVIVAL<br>4. OVERALL SURVIVAL;Primary end point(s): HEMATOLOGICAL AND EXTRAHEMATOLOGICAL TOXICITY RATE

Secondary Outcome Measures