Trial on Lenalidomide Given as Maintenance Therapy for Relapsed Diffuse Large B Cell Lymphoma

• Status: Unknown status
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: IRCCS San Raffaele
• Collaborator: Celgene Corporation
• Treatments: Lenalidomide; Thalidomide

Criteria

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 or CR to second-line chemotherapy (ICE or DHAP/DHAOx or MINE regimen) + rituximab

• ECOG 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 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/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