Trial on Lenalidomide Given as Maintenance Therapy for Relapsed Diffuse Large B Cell Lymphoma (NCT00799513) | Clinical Trial Compass
CompletedPhase 2
Trial on Lenalidomide Given as Maintenance Therapy for Relapsed Diffuse Large B Cell Lymphoma
Italy48 participantsStarted 2009-03
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …