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
- Conditions
- Health Condition 1: D758- Other specified diseases of bloodand blood-forming organs
- Registration Number
- CTRI/2023/02/049675
- Lead Sponsor
- Johnson & Johnson Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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
-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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Phase 2 - CR rate, incidence and severity of AEs and SAEs, PFS <br/ ><br>Phase 3 - PFSTimepoint: â?¢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 Outcome Measures
Name Time Method Phase 2 - NA <br/ ><br>Phase 3 - <br/ ><br>-Overall response CR and PR----OS <br/ ><br>-TTNT <br/ ><br>-Incidence, type, and severity of AEsTimepoint: -Overall response <br/ ><br>CR - every 12 weeks for the first year - then every 16 <br/ ><br>weeks up to 3 years - then every 24 weeks until disease progression <br/ ><br>-TTNT - the date of commencement of the next line of therapy <br/ ><br>-OS - time from the date of randomization to the date of death from any cause <br/ ><br>-Incidence, type, and severity of adverse events - throughout the study