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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have been diagnosed with Waldenstrom macroglobulinemia.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Major Response Rate (MRR) in Cohort 1

Secondary outcome measures

CR + VGPR rate

Duration of Response (DOR)

Health-Related Quality of Life (HRQoL): NFLymSI-18

+6 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort 3Experimental Treatment1 Intervention

Participants with R/R disease to a BTK inhibitor treatment and are unsuitable for chemoimmunotherapy will receive BGB-11417 at a standard dose, given orally once daily.

Group II: 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 BGB-11417 at a standard dose, given orally once daily.

Group III: 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 BGB-11417 at a standard dose, given orally once daily.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

BeiGeneLead Sponsor

175 Previous Clinical Trials

28,740 Total Patients Enrolled

Study DirectorStudy DirectorBeiGene

1,211 Previous Clinical Trials

489,187 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings available for participation in this experiment?

"Per the information on clinicaltrials.gov, this medical trial is actively searching for participants. The experiment was first published on October 1st 2023 and has been updated as recently as September 18th 2023."

Answered by AI

Has the FDA issued official clearance for Cohort 1?

"Cohort 1 was rated a 2 out of 3 on our team's safety scale, as the Phase 2 trial has provided preliminary evidence for its security but lacks any efficacy data."

Answered by AI

What is the size of the patient sample for this experiment?

"Affirmative, the data posted on clinicaltrials.gov affirms that this research is presently seeking participants. The study commenced on October 1st 2023 and was last modified on September 18th 2023. This medical experiment needs to recruit 85 individuals from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia

2023. "Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05952037.

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