A phase II trial to evaluate the safety and activity of single-agent lenalidomide given as maintenance therapy after response to second-line therapy in patients with relapsed diffuse large B cell lymphoma, not eligible for high-dose chemotherapy and autologous transplantation [Lenalidomide and DLBCL - ND

Phase 1

• Conditions: patients affected by diffused linfoma with big cells; MedDRA version: 9.1Level: LLTClassification code 10012818Term: Diffuse large B-cell lymphoma

• Registration Number: EUCTR2008-003729-18-IT
• Lead Sponsor: OSPEDALE S. RAFFAELE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-06-13
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

- Age  65 years or younger but not eligible to high-dose chemotherapy and autologous stem cell transplantation - biopsy-proven DLBCL relapsed to previous combination chemotherapy regimen ± rituximab - PR or CR to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab - ECOG performance status score  3 - Female of childbearing potential (FCBP) must demonstrate to practice a proper contraception to avoid any pregnancy risk during the study and at least 28 days after the discontinuation of the study - Male subjects must agree to practice a proper contraception during any sexual contact with females childbearing potential
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

- CNS involvement - Prior ASCT - TTP <6 months after first-line therapy - Use of experimental drugs during second-line salvage chemotherapy - Severe concomitant illnesses / medical conditions (e.g. impaired respiratory and/or cardiac function, uncontrolled diabetes mellitus ) - Active infectious disease - HIV, HBV or HCV- positivity - Impaired liver function (Bilirubin >2 x upper normal limit; ALT/AST/GGT > 3 x upper normal limit) at one month from salvage chemotherapy conclusion - Impaired renal function (creatinine clearance <50 ml/min) at one month from salvage chemotherapy conclusion - Absolute neutrophil count (ANC) <1000/L - Platelet count <75.000 /mm3 - Hemoglobin <9 g/dL - Non-co-operative behaviour or non-compliance - Psychiatric diseases or conditions that might impair the ability to give informed consent - Pregnant or lactating females

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To explore the efficacy of lenalidomide monotherapy given as maintenance therapy following salvage chemotherapy in patients with relapsed or refractory DLBCL;Secondary Objective: To evaluate the safety of Lenalidomide maintenance therapy in this setting;Primary end point(s): One-year progression free survival