Venetoclax in combination with Ibrutinib and Rituximab or conventional chemotherapy (Bendamustine) and Ibrutinib and Rituximab in patients with Mantle Cell Lymphoma.
Key facts
- Where
- Berlin, Brandenburg an der Havel, Chemnitz, Dortmund, Essen, Halle Saale, Hamburg, Homburg, Karlsruhe, Kiel, Koblenz, Mainz, Minden, Moenchengladbach, Munich, Mutlangen, Paderborn, Regensburg, Rostock, Traunstein, Trier és Ulm, NémetországSee the 25 sites
- Phase
- 2. fázis
Where in Németország
- Charite Universitaetsmedizin Berlin KöRBerlin, NémetországTaking people
- Staedtisches Klinikum Brandenburg GmbHBrandenburg an der Havel, NémetországTaking people
- Klinikum Chemnitz gGmbHChemnitz, NémetországTaking people
- Kath. St. Paulus GmbHDortmund, NémetországTaking people
- KLINIKEN ESSEN SUED Evangelisches Krankenhaus Essen-Werden gGmbHEssen, NémetországTaking people
- Universitaetsklinikum Essen (AoR)Essen, NémetországTaking people
- Universitaetsklinikum Halle (Saale) AöRHalle Saale, NémetországTaking people
- OncoResearch Lerchenfeld GmbHHamburg, NémetországTaking people
- University Medical Center Hamburg-EppendorfHamburg, NémetországTaking people
- Universitaet Des SaarlandesHomburg, NémetországTaking people
- Staedtisches Klinikum Karlsruhe gGmbHKarlsruhe, NémetországTaking people
- Universitaetsklinikum Schleswig-HolsteinKiel, NémetországTaking people
- Gemeinschaftsklinikum Mittelrhein gGmbHKoblenz, NémetországTaking people
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöRMainz, NémetországTaking people
- Johannes Wesling Klinikum MindenMinden, NémetországTaking people
- Kliniken Maria Hilf GmbH MoenchengladbachMoenchengladbach, NémetországTaking people
- Klinikum der Universitaet Muenchen AöRMunich, NémetországTaking people
- Klinikum rechts der Isar der TU Muenchen AöRMunich, NémetországTaking people
- Kliniken Ostalb gemeinnuetzige kommunale Anstalt des oeffentlichen RechtsMutlangen, NémetországTaking people
- Medizinisches Versorgungszentrum des Bruederkrankenhauses St. Josef Paderborn gGmbHPaderborn, NémetországTaking people
- Barmherzige Brueder gemeinnuetzige Krankenhaus GmbHRegensburg, NémetországTaking people
- Rostock University Medical CenterRostock, NémetországTaking people
- Kliniken Suedostbayern AGTraunstein, NémetországTaking people
- Klinikum Mutterhaus der Borromaeerinnen gGmbHTrier, NémetországTaking people
- Universitaetsklinikum Ulm AoRUlm, NémetországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Universitatsmedizin der Johannes Gutenberg-Universitat Mainz KöR
- Trial code
- EU 2022-501808-96-00
- Record updated
- 2026. november 3.
- Original description
To evaluate efficacy in both treatment arms: Failure-Free Survival (FFS) at 30 from randomizationRead full original descriptionShow less
Venetoclax in combination with the BTK inhibitor Ibrutinib and Rituximab or conventional chemotherapy (Bendamustine) and Ibrutinib and Rituximab in patients with treatment naive Mantle Cell Lymphoma not eligible for high dose therapy
To evaluate efficacy in both treatment arms: Failure-Free Survival (FFS) at 30 from randomization
Inclusion: 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).
Exclusion: Major surgery within 4 weeks prior to first dose; 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; Vaccinated with live, attenuated vaccines within 4 weeks prior to first dose; Known bleeding disorder (e.g. von Willebrand disease; hemophilia) Serious concomitant disease interfering with a regular therapy according to the study protocol; 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; 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; 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; Requires anticoagulation with warfarin or equivalent vitamin K antagonists (e.g. phenprocoumon); Known CNS involvement of MCL.