Clinical trial · Interventional
Trial on Lenalidomide Given as Maintenance Therapy for Relapsed Diffuse Large B Cell Lymphoma
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)
NCT00799513CI-TRIAL-00075906RV-NHL-PI351completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lenalidomide
- description
- single-agent lenalidomide 25 mg once daily for 21 days out of 28, as maintenance treatment after the end of second-line chemotherapy until progression of disease.
- interventionNames
- Drug: Lenalidomide
Primary outcomes (1)
- measure
- 1-year Progression-free Survival
- timeFrame
- 1-year
- description
- It is defined as the number of participants alive after 1 year from enrolment to progression or relapse of lymphoma (if post-induction disease status was PR (Partial Response) or CR (Complete Response), respectively). Patients alive at last follow-up will be censored.
Secondary outcomes (4)
- measure
- Progression Free Survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDFerreri AJ, Sassone M, Zaja F, Re A, Spina M, Rocco AD, Fabbri A, Stelitano C, Frezzato M, Rusconi C, Zambello R, Couto S, Ren Y, Arcari A, Bertoldero G, Nonis A, Scarfo L, Calimeri T, Cecchetti C, Chiozzotto M, Govi S, Ponzoni M. Lenalidomide maintenance in patients with relapsed diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplantation: an open label, single-arm, multicentre phase 2 trial. Lancet Haematol. 2017 Mar;4(3):e137-e146. doi: 10.1016/S2352-3026(17)30016-9. Epub 2017 Feb 17. PMID 28219694
- DERIVEDVose JM, Habermann TM, Czuczman MS, Zinzani PL, Reeder CB, Tuscano JM, Lossos IS, Li J, Pietronigro D, Witzig TE. Single-agent lenalidomide is active in patients with relapsed or refractory aggressive non-Hodgkin lymphoma who received prior stem cell transplantation. Br J Haematol. 2013 Sep;162(5):639-47. doi: 10.1111/bjh.12449. Epub 2013 Jul 9. PMID 23834234