Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patien… (NCT06547866) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia
France102 participantsStarted 2025-12-01
Plain-language summary
This is a French multicenter open label non-randomized Phase II trial evaluating the efficacy and tolerance of a combination of oral zanubrutinib and BGB-11417 in subjects aged 18 years and older with previously treated Waldenström macroglobulinemia (WM) who require therapy according to the consensus panel criteria from the Second International Workshop on Waldenström's macroglobulinemia.
population : Patients with previously treated Waldenstrom macroglobulinemia
The investigational medicinal products (IMP) are Zanubrutinib (BGB- 3111) and BGB-11417.Treatment will be administered for a total of twenty 28 day cycles:
* Cycle 1 with zanubrutinib only
* Cycle 2 with zanubrutinib plus BGB-11417 ramp-up
* cycle 2, day 1 : 10mg
* cycle 2, day 2 : 20 mg
* cycle 2, day 3 : 40mg
* cycle 2, day 4-7 : 80md daily
* cycle 2, day 8 and beyond : 160 mg daily
* Cycles 3-20 with zanubrutinib plus BGB-11417 full dose
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Be ≥ 18-year-old.
✓. Have received at least 1 prior line of treatment (excluding treatment with any BTKi or Bcl-2 antagonist, see non-inclusion criteria).
✓. Provide written informed consent.
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
✓. Have adequate renal function defined as creatinine clearance ≥ 50 mL/min as determined by the Cockroft-Gault equation.
✓. Have adequate hepatic function defined as:
✓. Have adequate BM function defined as:
✓. For women of childbearing potential, a negative pregnancy test must be documented prior to enrollment.
Exclusion criteria
✕. Have previously been treated with a BTK inhibitor.
✕. Have been previously treated with a bcl-2 antagonist.
✕. Have active central nervous system (CNS) disease as evidenced by cytology or pathology. In the absence of clinical signs of CNS disease, a lumbar puncture is not mandatory.
✕. Have significant or active cardiovascular disease:
✕. Have a history of stroke or intracranial hemorrhage within 6 months before first dose of study drug, have a history of a severe bleeding disorder such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring blood transfusion or other medical intervention:
✕. Have received live vaccine within 4 weeks of inclusion.
✕. Receive other concomitant investigational therapy.
✕. Have a history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, or hepatic condition that, in the opinion of the Investigator, would adversely affect a subject's participation in the study.