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BCL2 Inhibitor
BGB-11417 for Waldenström's Macroglobulinemia
Phase 2
Recruiting
Research Sponsored by BeiGene
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Clinical and definitive histologic diagnosis of WM
Be older than 18 years old
Must not have
Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma
Central nervous system (CNS) involvement by WM
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to approximately 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test a drug for a rare form of cancer to see if it’s safe and effective.
Who is the study for?
This trial is for people with Waldenström's Macroglobulinemia who have tried other treatments that didn't work or stopped working. They should not have had any other cancers in the last two years, no brain involvement from their disease, and no recent serious infections.
What is being tested?
The study tests BGB-11417, a drug designed to block a protein called BCL2 that helps cancer cells survive. Participants are grouped into three cohorts to assess how well the drug works and its safety in those with relapsed/refractory Waldenström's Macroglobulinemia.
What are the potential side effects?
While specific side effects of BGB-11417 aren't listed here, similar drugs often cause nausea, diarrhea, fatigue, low blood cell counts increasing infection risk, and potential liver issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with Waldenstrom macroglobulinemia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My lymphoma has changed into a more aggressive form.
Select...
My cancer has spread to my brain or spinal cord.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to approximately 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cohort 1: Major Response Rate (MRR)
Secondary study objectives
All Cohorts: CR + VGPR as assessed by the Investigator
All Cohorts: DOR as assessed by the investigator
All Cohorts: DoMR as assessed by the Investigator
+14 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment2 Interventions
Participants with previously untreated WM will receive sonrotoclax and zanubrutinib combination therapy with fixed duration.
Group II: Cohort 3Experimental Treatment1 Intervention
Participants with R/R disease to a BTK inhibitor treatment and are unsuitable for chemoimmunotherapy will receive sonrotoclax at a standard dose, given orally once daily.
Group III: Cohort 2Experimental Treatment1 Intervention
Participants with R/R disease to anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor and were intolerant to BTK inhibitor will receive sonrotoclax at a standard dose, given orally once daily.
Group IV: Cohort 1Experimental Treatment1 Intervention
Participants with R/R disease to both Bruton tyrosine kinase (BTK) inhibitor and anti-CD20 antibody-based systemic therapy containing chemotherapy or proteasome inhibitor will receive sonrotoclax at a standard dose, given orally once daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Zanubrutinib
2017
Completed Phase 3
~2160
Find a Location
Who is running the clinical trial?
BeiGeneLead Sponsor
200 Previous Clinical Trials
31,540 Total Patients Enrolled
9 Trials studying Waldenstrom Macroglobulinemia
1,351 Patients Enrolled for Waldenstrom Macroglobulinemia
Study DirectorStudy DirectorBeiGene
1,289 Previous Clinical Trials
502,268 Total Patients Enrolled
5 Trials studying Waldenstrom Macroglobulinemia
1,104 Patients Enrolled for Waldenstrom Macroglobulinemia