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
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 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.
stage III to IV congestive heart failure (CHF) as determined by the New York Heart Association (NYHA) classification system for heart failure and/or with left ventricular ejection fraction < 50%
French Innovative Leukemia Organisation
Lead sponsor
BeiGene
Collaborator