Clinical trial · Interventional
Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma.
Lenalidomide, Bendamustine and Rituximab as First-line Therapy for Patients Over 65 Years With Mantle Cell Lymphoma - a Nordic Lymphoma Group Trial
NCT00963534CI-TRIAL-00032016LENA-BERITcompletedPhase 1 / Phase 2ClinicalTrials.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)
In phase I: Establishing maximally tolerated dose of lenalidomide in combination with bendamustine and rituximab. In phase II: Evaluation of progression free survival with treatment with lenalidomide, bendamustine and rituximab
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 |
|---|---|---|---|
| Mantle Cell Lymphoma | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lenalidomide, bendamustine, rituximab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- lenalidomide, bendamustine, rituximab
- interventionNames
- Drug: lenalidomide, bendamustine, rituximab
Primary outcomes (1)
- measure
- MTD of lenalidomide (phase I) Progression free survival (phase II)
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age over 65 years, or age under 65 years, unable to tolerate high dose chemotherapy with autologous stem cell support * Histologically confirmed mantle cell lymphoma, stage II-IV at time of diagnosis * No previous treatment for lymphoma except radiotherapy or one cycle of any chemotherapy regimen for lymphoma * WHO Performance Status 0-3 * Written informed concent * Female subjects of childbearing potential must agree to use and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, through study drug therapy and for 4 weeks after the end of study drug therapy * Male subjects must agree to use condoms throughout study drug therapy if their partner is of childbearing potential, and has no contraception, and agree to not donate semen during study drug therapy and for one week after end of study drug therapy * All subjects must agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation, and agree not to share study medication with another person Exclusion Criteria: * Impaired liver function * ANC less than 1.0 x 10 9, unless caused by bone marrow infiltration by lymphoma * Platelet count less than 60 x 10 9, unless caused by bone marrow infiltration by lymphoma * Creatinine clearance below 50 ml/min (cockcroft formula)) * Known HIV positivity * Known seropositivity for HCV, HBsAG, anti-HBc, or other active infection uncontrolled by treatment * Psychiatric illness or condition which could interfere with the subject´s ability to understand the requirements of the study * Requirement of corticosteroid therapy at a dose over 10 mg prednisolone/day * Pregnant or lactating females
References
Publications (1)
- DERIVEDAlbertsson-Lindblad A, Kolstad A, Laurell A, Raty R, Gronbaek K, Sundberg J, Pedersen LB, Ralfkiaer E, Karjalainen-Lindsberg ML, Sundstrom C, Ehinger M, Geisler C, Jerkeman M. Lenalidomide-bendamustine-rituximab in patients older than 65 years with untreated mantle cell lymphoma. Blood. 2016 Oct 6;128(14):1814-1820. doi: 10.1182/blood-2016-03-704023. Epub 2016 Jun 27. PMID 27354719