Clinical trial · Interventional
A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma
A Randomized, Controlled, Open-label, Multicenter, Inferentially Seamless Phase 2/3 Study of Ibrutinib in Combination With Rituximab Versus Physician's Choice of Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab in Participants With Relapsed or Refractory Mantle Cell Lymphoma
NCT05564052CI-TRIAL-00096364VEGAcompletedPhase 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)
The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.
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 |
|---|---|---|---|
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Ibrutinib | Drug | Ibrutinib | ALIAS |
| Lenalidomide | Drug | Lenalidomide | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Phase 2: Treatment Arm A1 (Rituximab plus Ibrutinib)
- description
- Participants will receive rituximab 375 milligrams per meter square (mg/m\^2) intravenously (IV) on Day 1 of Cycles 1 to 6 with ibrutinib 560 milligrams (mg) orally, once daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days).
- interventionNames
- Drug: Ibrutinib
- Drug: Rituximab
- type
- EXPERIMENTAL
- label
- Phase 2: Treatment Arm A2 (Rituximab plus Ibrutinib)
- description
- Participants will receive rituximab 375 mg/m\^2 IV on Day 1 of Cycles 1 to 6 with ibrutinib 420 mg orally, once daily starting on Day 1 of Cycle 1 until disease progression or unacceptable toxicity (each cycle length is 28 days).
- interventionNames
- Drug: Ibrutinib
- Drug: Rituximab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least 1 prior treatment regimen for mantle cell lymphoma (MCL) excluding inhibitor of Bruton's tyrosine kinase (BTKi) * Documented disease progression or relapse following the last anti-MCL treatment * At least 1 measurable site of disease on cross-sectional imaging that is greater than or equal to (\>=) 2.0 centimeters (cm) in the longest diameter and measurable in 2 perpendicular dimensions per computed tomography (CT) * Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 Exclusion Criteria: * Prior therapy with ibrutinib or other BTK inhibitor * Prior treatment with both lenalidomide and bortezomib. Prior treatment with only 1 of these therapies is allowed * Major surgery within 4 weeks of randomization * Concurrent enrollment in another therapeutic investigational study * Known central nervous system lymphoma * History of stroke or intracranial hemorrhage within 6 months prior to randomization
References
Publications (0)
Data not yet available
No reference posted for this study.