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 DLBCL, Not Eligible for High-dose Chemotherapy and ASCT (Autologous Stem-Cell Transplantation)

2008-003729-18

This phase II multi-institutional trial will explore the safety and efficacy of lenalidomide monotherapy given as maintenance therapy following salvage chemo-immunotherapy in patients with relapsed or refractory chemosensitive diffuse large B-cell lymphoma

2009-03-01

2017-03-01

2021-08-01

Completed

Early phase I

48

Inclusion Criteria: * Age \> 65 years * Age \< 65 but not eligible to high-dose chemotherapy and autologous stem cell transplantation * Biopsy-proven DLBCL relapsed to previous combination chemotherapy regimen ± rituximab * PR (Partial Response) or CR (Complete Response) to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab * ECOG (Eastern Cooperative Oncology Group) performance status score \< 4 * 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 Exclusion Criteria: * CNS (Central Nervous System) involvement * Prior ASCT * TTP (Time To Progression) \<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 (Hepatitis B Virus) or HCV (Hepatitis C Virus) - positivity * Impaired liver function (Bilirubin \>2 x upper normal limit; ALT (alanine aminotransferase) /AST (aspartate aminotransferase) /GGT (γ-glutamyltransferase) \> 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/microL * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 48, 'type': 'ACTUAL'}}

2024-04-10