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Venetoclax in combination with Ibrutinib and Rituximab or conventional chemotherapy (Bendamustine) and Ibrutinib and Rituximab in patients with Mantle Cell Lymphoma.
EU CTIS ID: 2022-501808-96-00
What this study is testing
To evaluate efficacy in both treatment arms: Failure-Free Survival (FFS) at 30 from randomization
- 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
- Histologically confirmed diagnosis of MCL according to WHO classification
- Creatinine ≤ 2 mg/dL or eGFR ≥ 50 mL/min
- Written informed consent form according to ICH/EU GCP and national regulations
- Sexually active men with female partners of child-bearing potential potential must agree to use highly effective contraceptives
- previously untreated stage II-IV (Ann Arbor), previous local therapyi e.g. radiation therapy to single lesion is eligible, a limited pre-phase treatment with steroids for patients at need is allowed (s. treatment)
- ≥ 60 years and not suitable for autologous SCT
You likely can't join if
- Major surgery within 4 weeks prior to first dose
- Cardiac (Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below LLN)
- Patients requiring double platelet inhibition, e.g due to cardiovascular intervention
- clinically significant pulmonary dysfunction interfering with the conduct of the trial treatment
- any other significant medical condition interfering with the conduct of the trial treatment
- Patients with unresolved hepatitis B or C infection or known HIV positive infection (mandatory test) Concomitant or previous malignancies within the last 3 years other than basal cell skin cancer, Prostate cancer in remission with PSA within normal range or in situ uterine cervix cancer
See the full eligibility criteria
Who can join
- Histologically confirmed diagnosis of MCL according to WHO classification
- Creatinine ≤ 2 mg/dL or eGFR ≥ 50 mL/min
- Written informed consent form according to ICH/EU GCP and national regulations
- Sexually active men with female partners of child-bearing potential potential must agree to use highly effective contraceptives
- previously untreated stage II-IV (Ann Arbor), previous local therapyi e.g. radiation therapy to single lesion is eligible, a limited pre-phase treatment with steroids for patients at need is allowed (s. treatment)
- ≥ 60 years and not suitable for autologous SCT
- At least 1 measurable lesion; in case of bone marrow infiltration only, bone marrow aspiration and biopsy is mandatory for all staging evaluations.
- ECOG performance status ≤ 2
- Absolute neutrophil count (ANC) ≥ 1000 cells/μL
- Platelets ≥75.000 cells/μL
- Transaminases (AST and ALT) ≤3 x ULN
- Total bilirubin ≤ 2 x ULN unless other reason known (Gilbert- Meulengracht-Syndrome)
What rules you out
- Major surgery within 4 weeks prior to first dose
- Cardiac (Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification or LVEF below LLN)
- Patients requiring double platelet inhibition, e.g due to cardiovascular intervention
- clinically significant pulmonary dysfunction interfering with the conduct of the trial treatment
- any other significant medical condition interfering with the conduct of the trial treatment
- Patients with unresolved hepatitis B or C infection or known HIV positive infection (mandatory test) Concomitant or previous malignancies within the last 3 years other than basal cell skin cancer, Prostate cancer in remission with PSA within normal range or in situ uterine cervix cancer
- Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon)
- History of stroke or intracranial hemorrhage within 6 months prior to first dose
- Treatment with strong or moderate CYP3A4/5 inhibitors/inducers within 7 days before first dose and during Venetoclax and Ibrutinib intake
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of Ibrutinib capsules, or put the study outcomes at undue risk
- Vaccinated with live, attenuated vaccines within 4 weeks prior to first dose
- Known CNS involvement of MCL
- Known bleeding disorder (e.g. von Willebrand disease; hemophilia) Serious concomitant disease interfering with a regular therapy according to the study protocol
The study team makes the final eligibility decision.
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.
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.