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-GR
- Lead Sponsor
- Janssen-Cilag International NV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 36
-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 14
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22
-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: The primary objective of Protocol Amendment 1 is to provide continued access to study treatment for participants who continued to benefit from treatment.nib + rituximab versus physician’s choice of lenalidomide + rituximab or bortezomib + rituximab;Secondary Objective: Not applicable;Primary end point(s): None, based on Protocol Amendment 1;Timepoint(s) of evaluation of this end point: Not applicable
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable<br>;Timepoint(s) of evaluation of this end point: Not applicable