Clinical trial · Interventional
A Study to Evaluate the Efficacy of Lenalidomide as Maintenance Therapy After Completion of First-line Combination Chemotherapy in Patients With Mantle Cell Lymphoma (MCL).
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated by sponsor due to new unpublished data that rendered the current design of the study no longer clinically relevant. There were no safety concerns.
Summary
Brief summary (as posted)
A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR). This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lenalidomide
- description
- Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
- interventionNames
- Drug: Lenalidomide
- type
- EXPERIMENTAL
- label
- Placebo
- description
- Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically-proven mantle cell non-Hodgkin's lymphoma, * One of the following first-line induction chemotherapy regimens with rituximab: (1) combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen such as FC (fludarabine, cyclophosphamide) * Achieved a PR or better response after the first-line induction chemotherapy regimen (assessed by 2007 Revised Response Criteria for Malignant Lymphoma) * ECOG performance status score of ≤ 2 * Willing to follow pregnancy precaution Exclusion Criteria: * Patients who have received more than 1 line of induction chemotherapy; * Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are ineligible; * Patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy; * Any of the following laboratory abnormalities: * Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5\*10\^9/L) * Platelet count \< 60,000/mm\^3 (60\*10\^9/L) * Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) \> 3.0 times upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma * Serum bilirubin \> 1.5 times ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma * Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of \< 30 mL /min * Active or any history of central nervous system (CNS) lymphoma or leptomeningeal involvement by lymphoma * Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT prophylaxis * Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)
References
Publications (1)
- 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