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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 below

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I have been diagnosed with Waldenstrom macroglobulinemia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My lymphoma has changed into a more aggressive form.

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 5 years for reporting.

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 more

Awards & 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

0 / 3Eligibility criteria met