Phase 2
N=36
A Study of Ibrutinib With Rituximab in Relapsed or Refractory Mantle Cell Lymphoma
Lymphoma, Mantle-Cell
Bottom Line
View on ClinicalTrials.gov: NCT05564052 ↗Enrolled (actual)
36
Serious AEs
33.3%
Results posted
Jan 2025
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and B — 1; 0; 0; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibrutinib (Drug); Lenalidomide (Drug); Rituximab (Drug); Bortezomib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen Research & Development, LLC
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Arms A1, A2, A3 and B |
1; 0; 0; 2; 0; 1 | — |
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation of Treatment: Monotherapy Arm |
1 | — |
| PRIMARY Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0: Arms A1, A2, A3 and B |
7; 3; 5; 8 | — |
| PRIMARY Number of Participants With Grade 3 or Higher TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version (v) 5.0: Monotherapy Arm |
1 | — |
| PRIMARY Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Arms A1, A2, A3 and B |
4; 3; 2; 5 | — |
| PRIMARY Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs): Monotherapy Arm |
1 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Arms A1, A2, A3 and B |
1; 3; 2; 2; 0; 3 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities: Hematology Parameters: Monotherapy Arm |
1; 8; 2; 5; 1; 5 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Arms A1, A2, A3 and B |
5; 9; 8; 6; 4; 0 | — |
| PRIMARY Number of Participants With Clinical Laboratory Abnormalities: Chemistry Parameters: Monotherapy Arm |
8; 6; 2; 8; 8; 8 | — |
Summary
The purpose of this study is to provide continued access to treatment for participants who continue to benefit from treatment.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT05564052). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.