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Seamless Phase 2/3 Study of Ibrutinib With Rituximab in Relapsed/Refractory Mantle Cell Lymphoma
EU CTIS ID: 2023-503618-64-00
What this study is testing
To provide continued access to study treatment for participants who continued to benefit from treatment
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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/mm3 Platelets ≥50,000 cells/mm3 Hemoglobin ≥8 g/dL ALT/AST ≤3 X ULN Total bilirubin ≤1.5 X ULN CrCl ≥30 mL/min
You likely can't join if
- Prior therapy with BTKi
- Known history of HIV
- Active Hep B/C and E infection
- Prior therapy with both Lenalidomide and Bortezomib
- Major surgery within 4 weeks
- History of stroke or intracranial hemorrhage within 6 month prior to randomization
See the full eligibility 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: ANC ≥ 1000/mm3 Platelets ≥50,000 cells/mm3 Hemoglobin ≥8 g/dL ALT/AST ≤3 X ULN Total bilirubin ≤1.5 X ULN CrCl ≥30 mL/min
- Must not be diagnosed or treated for malignancy other than MCL (with exceptions)
- FOCBP and male participants with partners of childbearing potential must also comply with strict pregnancy prevention plan
- Prior therapy with BTKi
- Known history of HIV
- Active Hep B/C and E infection
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Thailand
- Brazil
- Taiwan
- Turkey
- Malaysia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Thailand; Brazil; Taiwan; Turkey; Malaysia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.