A phase III, multicentric randomized study for the treatment of young patients with unfavorable prognosis Diffuse Large Cell B Lymphoma IPI 2-3 . Dose-dense chemotherapy Rituximab +/- intensive and high-dose chemo-immunotherapy with autologus pheripherical staminal cells. - IIL/DLCL04

• Conditions: Patients with Diffuse Large B Cell Lymphoma.; Level: PTClassification code 10012826

• Registration Number: EUCTR2007-000275-42-IT
• Lead Sponsor: IIL INTERGRUPPO ITALIANO LINFOMI ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-01-16
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 376

Inclusion Criteria

61553; Age 18-60 61553; Diagnosis of B DLCL CD 20 new diagnosis or shift from low grade NHL not pre-treated or grade 3b Follicular Lymphoma 61553; Stage II advanced, III, IV with two or more risk factors 61553; Age-adjusted IPI 2-3 61553; PS 3 not due to the lymphoma 61553; Cardiac ejection fraction 45 61553; No impairment of renal, hepatic and pulmonary function 61553; Markers HIV, HBV e HCV negative 61553; HCV if without replication signs, istologically confirmed 61553; AntiHBc , HbsAg-, AntiHBs /- portatori occulti with HBV-DNA negative or weakly positive 61553; Life espectation 3 months 61553; No pregnancy at the start of chemotherapy 61553; Writted 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

61553; Lymphoblastic NHL 61553; Burkitt s Lymphoma 61553; CD20 negative Lymphoma 61553; Follicular or Mantle Lymphoma 61553; Primitive mediastinic Lymphoma with only intrathoracic localization 61553; Age 60 61553; Stage I 61553; Age-adjusted IPI 0-1 61553; PS 3 if not due to the Lymphoma 61553; Creatinine 1.2 mg/dl o creatinine clearance 60 ml/min. 61553; AST/ALT o bilirubine 2.5 the normal value if not due to the Lymphoma. 61553; Serious arterial hypertension not controlled, cardiac arrhythmia not controlled, symptomatic ventricular arrhytmias, congestive heart failure classe NYHA classe III-IV, acute myocardial infarction. 61553; Ventricular ejecton fractionr 45 61553; Important pulmonary disease. Impairment of pulmonary function BPCO, pulmonary fibrosis, TBC 61553; No evidence of active opportunistic infection 61553; HIV positivity 61553; HBV positivity 61553; AntiHBc , HbsAg-, AntiHBs /- with HBV-DNA positive 61553; HCV positivity with active replication signs HCV , PCR , AST 1.5-2x normal 61553; No evidence of symptomatic CNS disease 61553; No prior diagnosis of neoplasm within 3 years, except cervical intraepithelial neoplasia type 1 CIN1 or localized non-melanomatous skin cancer or localized prostatic carcinoma surgically treated, good prognosis DCIS only surgically treated 61553; Pregnancy at the start of chemotherapy 61553; No appropriate contraceptive method in women of childbearing potential or men during the chemotherapy and next six months. 61553; Psychiatric illness precluding understanding concepts of the trial or signing informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified