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Study Evaluating the Efficacy and Tolerance of a Zanubrutinib and BGB-11417 Combination in Patients Previously Treated for Waldenström Macroglobulinemia

ConditionWaldenstrom Macroglobulinemia
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrench Innovative Leukemia Organisation

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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%

Trial design

Design model

Single group

Treatments tested in this trial

  • zanubrutinib + BGB-11417

    Drug

    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

Treatment groups

102 Participants
are divided into 1 treatment group
Group A: Zanubrutinb + BGB-11417Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary endpoint

Number of subjects achieving a CR or VGPR at any time during the course of treatment

Time frame
twenty 28-days cycles

Secondary outcomes

1

Overall response rate (ORR)

Number of subjects achieving a best response (CR, VGPR, PR or minor response)

Time frame
at any time during the course of study treatment (twenty 28-days cycles)
2

Major response rate (MRR)

Number of subjects achieving a best response (CR, VGPR or PR)

Time frame
at any time during the course of study treatment (twenty 28-days cycles)
3

Time to response (TTR)

time to achieve of at least a minor response

Time frame
From start to end of treatment (twenty 28-days cycles)
4

Progression free survival (PFS)

time to disease progression or death from any cause

Time frame
From start of treatment to end fo Fup (twenty 28-days cycles + 3 years Fup)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

French Innovative Leukemia Organisation

Lead sponsor

BeiGene

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: