A Study of Ibrutinib in Combination With Rituximab Versus Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab, in patients with Mantle Cell Lymphoma who have Relapsed or are Refractory to current treatments

A Randomized, Controlled, Open-label, Multicenter, Inferentially Seamless Phase 2/3 Study of Ibrutinib in Combination With Rituximab Versus Physicians Choice of Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab in Participants with Relapsed or Refractory Mantle Cell Lymphoma - VEGA

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/02/049675

Enrollment

490

Registered

2023-02-13

Start date

Unknown

Completion date

Unknown

Last updated

2024-12-09

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

Conditions

Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs

Interventions

Intervention1: Ibrutinib in Combination With Rituximab: Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab Intervention2: Ibrutinib: Ibrutinib –560 mg QD (4×140 mg) - capsules- oral Ibrutinib –4

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients with confirmed MCL -At least 1 prior treatment regimen for MCL excl. BTKi -Documented disease progression or relapse following the last anti-MCL treatment -Measurable nodal disease -ECOG =1 -Adequate organ function

Exclusion criteria

Exclusion criteria: -Prior therapy with BTKi -Prior therapy with both Lenalidomide and Bortezomib -Major surgery within 4 weeks -History of stroke or intracranial hemorrhage within 6 month prior to randomization -Central nervous system lymphoma -Bleeding disorder -Clinically significant cardiovascular disease uncontrolled arrhythmia, or Class II-IV congestive heart failure as defined by NYHA or a history of MI, unstable angina, or acute coronary syndrome within 1 year prior to randomization or uncontrolled HTN under treatment with 3 or more HTN medications -Anticancer therapy -Uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction -HIV, active Hep B or C and E infection

Design outcomes

Primary

Measure	Time frame
Phase 2 - CR rate, incidence and severity of AEs and SAEs, PFS Phase 3 - PFSTimepoint: •Overall response, CR - every 12 weeks for the first year, then every 16 weeks up to 3 years, then every 24 weeks until disease progression.	—

Secondary

Measure	Time frame
Phase 2 - NA Phase 3 - -Overall response CR and PR----OS -TTNT -Incidence, type, and severity of AEsTimepoint: -Overall response CR - every 12 weeks for the first year - then every 16 weeks up to 3 years - then every 24 weeks until disease progression -TTNT - the date of commencement of the next line of therapy -OS - time from the date of randomization to the date of death from any cause -Incidence, type, and severity of adverse events - throughout the study	—

Measure

Time frame

Phase 2 - NA Phase 3 - -Overall response CR and PR----OS -TTNT -Incidence, type, and severity of AEsTimepoint: -Overall response CR - every 12 weeks for the first year - then every 16 weeks up to 3 years - then every 24 weeks until disease progression -TTNT - the date of commencement of the next line of therapy -OS - time from the date of randomization to the date of death from any cause -Incidence, type, and severity of adverse events - throughout the study

—

Countries

Brazil, China, Croatia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Malaysia, Mexico, Norway, Peru, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, United States of America

Contacts

Public ContactDr Sanish Davis

Johnson and Johnson Private Limited

SDavis20@ITS.JNJ.com9820958943

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026