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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-503618-64-00

Acronym

54179060MCL3004

Enrollment

Registered

2023-11-17

Start date

2022-11-16

Completion date

2024-09-18

Last updated

2024-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed/Refractory Mantle Cell Lymphoma

Brief summary

None

Interventions

DRUGLenalidomide Accord 10 mg hard capsules

DRUGLenalidomide Accord 20 mg hard capsules

DRUGLenalidomide Accord 5 mg hard capsules

DRUGLenalidomide Accord 2.5 mg hard capsules

DRUGIMBRUVICA 140 mg hard capsules

DRUGVELCADE 3.5 mg powder for solution for injection

DRUGLenalidomide Accord 15 mg hard capsules

DRUGJNJ-54179060

DRUGRuxience 500 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
None	—

Countries

Czechia, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026