A Study of Ibrutinib in Combination With Rituximab Versus Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab, in Relapsed/Refractory Mantle Cell Lymphoma
- Conditions
- Relapsed or Refractory Mantle Cell LymphomaMedDRA version: 20.0Level: HLTClassification code 10026798Term: Mantle cell lymphomasSystem Organ Class: 100000004851Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2022-000364-21-PL
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 490
-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
ANC = 1000/mm^3
Platelets =50,000 cells/mm^3
Hemoglobin =8 g/dL
ALT/AST =3 X ULN
Total bilirubin =1.5 X ULN
CrCl =30 mL/min
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90
-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 (e.g., 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 (if >1 yr., a cardiology consultation documenting cardiac clearance is required) or uncontrolled HTN under treatment with 3 or more HTN medications, screening systolic BP>160 mm HG or diastolic BP>100mm Hg
-Anticancer therapy including chemotherapy, radiotherapy, small molecule, monoclonal antibody and investigational agents =21 days (or at least 5 drug half-lives, whichever is shorter) prior to first administration of study treatment.
-Uncontrolled active systemic infection or any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the participant’s safety, or interfere with the absorption or metabolism of ibrutinib (including uncontrolled diabetes mellitus or HbA1C>7)
-HIV, active Hep B/C and E infection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Phase 2: To determine the recommended dosage of ibrutinib when administered in combination with rituximab in participants with r/r MCL<br>Phase 3: To compare the PFS of ibrutinib + rituximab versus physician’s choice of lenalidomide + rituximab or bortezomib + rituximab;Secondary Objective: Phase 2: Not applicable<br>Phase 3: To compare overall response rate, overall survival, complete response rate, time to next treatment, and to evaluate safety.;Primary end point(s): Phase 2: CR rate, incidence and severity of AEs and SAEs, PFS<br>Phase 3: PFS;Timepoint(s) of evaluation of this end point: Time from randomization to disease progression or death
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Phase 2: not applicable<br>Phase 3: <br>•Overall response (CR+ PR) <br>•OS <br>•CR <br>•TTNT <br>•Incidence, type, and severity of AEs<br>;Timepoint(s) of evaluation of this end point: •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.<br>•TTNT - the date of commencement of the next line of therapy<br>•OS - time from the date of randomization to the date of death from any cause<br>•Incidence, type, and severity of adverse events (AEs) - throughout the study