Save

Study to Evaluate the Efficacy and Safety of Sonrotoclax in Participants With Waldenström's Macroglobulinemia

PHASE2RECRUITING

This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 (sonrotoclax) in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) and in combination with zanubrutinib in adult participants with previously untreated WM.

Simpliy with AI

Study details:

This study will test whether BGB-11417 (sonrotoclax) can be used to improve outcomes in participants with Waldenström's Macroglobulinemia (WM) both when used alone in those who have not responded well to conventional treatments and when used in combination with zanubrutinib in those who have not yet received treatment. The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment, and to determine what adverse events, or side effects, participants might experience. BCL2 is a key protein involved in cell death, and abnormal levels of BCL2 are associated with many cancers.

Blocking the action of BCL2 proteins is a promising approach with potential therapeutic benefits in participants with different types of cancers, including WM. This study will enroll approximately 105 participants. All participants will receive sonrotoclax orally as a tablet.

The study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 5 years. Treatments will continue until participants experience worsening disease status, too many side effects, or withdraw consent.

Simplify with AI

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Clinical and definitive histologic diagnosis of WM.

Meeting ≥ 1 criterion for treatment according to consensus panel criteria from the 2nd International Workshop on Waldenström's Macroglobulinemia (IWWM).

For Cohorts 1-3, refractory or relapsed disease to the most recent therapy at study entry unless participants had intolerance to the most recent therapy. Refractory disease is defined as not attaining at least a major response, or progressing while on or within 6 months of completing therapy. Relapsed disease is defined as attaining at least a major response to therapy and meeting the criteria for disease progression beyond 6 months after completing therapy.

For Cohort 4, patients must not have received prior therapy for WM.

Adequate organ function.

Exclusion criteria

Central nervous system (CNS) involvement by WM.

Transformation to aggressive lymphoma, such as diffuse large B-cell lymphoma.

History of other malignancies ≤ 2 years before study entry.

Uncontrolled active systemic infection or recent infection requiring parenteral antimicrobial therapy that was completed ≤ 14 days before the first dose of the study drug.

Simplify with AI

Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-09-28

Primary completion: 2027-11-01

Study completion finish: 2028-09-01

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05952037

Intervention or treatment

DRUG: BGB-11417

DRUG: Zanubrutinib

Conditions

• Waldenstrom Macroglobulinemia
• Waldenstrom's Macroglobulinemia Recurrent
• Waldenstrom's Macroglobulinemia Refractory

Image related to Waldenstrom Macroglobulinemia

Condition: Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent and more
DRUG: BGB-11417 and other drugs
Concord, New South Wales, Australia and more
Sponsor: BeiGene

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Concord Repatriation General Hospital

Research sites nearby

Select from list below to view details:

Concord Repatriation General Hospital
Concord, New South Wales, Australia
Monash Health
Clayton, Victoria, Australia
Flinders Medical Centre
Bedford PK, South Australia, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cohort 1 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.	DRUG: BGB-11417 Administered orally as a tablet.
EXPERIMENTAL: Cohort 2 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.	DRUG: BGB-11417 Administered orally as a tablet.
EXPERIMENTAL: Cohort 3 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.	DRUG: BGB-11417 Administered orally as a tablet.
EXPERIMENTAL: Cohort 4 Participants with previously untreated WM will receive sonrotoclax and zanubrutinib combination therapy with fixed duration.	DRUG: BGB-11417 Administered orally as a tablet.

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Cohort 1: Major Response Rate (MRR)	MRR is defined as the proportion of participants achieving partial response (PR) or better, as assessed by the Independent Review Committee (IRC) per the 11th International Workshop on Waldenström Macroglobulinemia (IWWM-11) WM response criteria.	Up to approximately 4 years

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Cohorts 2 and 3: MRR as assessed by the IRC	MRR is defined as the proportion of participants achieving PR or better.	Up to approximately 5 years
All Cohorts: MRR as assessed by the Investigator	MRR is defined as the proportion of participants achieving PR or better.	Up to approximately 5 years
Cohorts 1, 2, and 3: Duration of Major Response (DoMR) as assessed by the IRC	DoMR is defined as the time from first determination of major response until first documentation of progression or death, whichever occurs first.	Up to approximately 5 years
All Cohorts: DoMR as assessed by the Investigator	DoMR is defined as the time from first determination of major response until first documentation of progression or death, whichever occurs first.	Up to approximately 5 years
Cohorts 1, 2, and 3: Complete Response (CR) + Very Good Partial Response (VGPR) as assessed by the IRC	CR + VGPR is defined as the percentage of participants who achieve CR or VGPR.	Up to approximately 5 years
All Cohorts: CR + VGPR as assessed by the Investigator	CR + VGPR is defined as the percentage of participants who achieve CR or VGPR.	Up to approximately 5 years
Cohorts 1, 2, and 3: Overall Response Rate (ORR) as assessed by the IRC	ORR is defined as the percentage of participants with minor response (MR) or better.	Up to approximately 5 years
All cohorts: ORR as assessed by the investigator	ORR is defined as the percentage of participants with MR or better.	Up to approximately 5 years
Cohorts 1, 2, and 3: Duration of Response (DOR) as assessed by the IRC	DOR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first.	Up to approximately 5 years
All Cohorts: DOR as assessed by the investigator	DOR is defined as the time from first determination of response until first documentation of progression or death, whichever occurs first.	Up to approximately 5 years
Cohorts 1, 2, and 3: Progression-Free Survival (PFS)	PFS is defined as the time from first dose until first documentation of progression or death, whichever comes first, as assessed by the IRC and by the investigator.	Up to approximately 5 years
Cohorts 1, 2, and 3: Time to major response as assessed by the IRC	Time to major response is defined as the time from start of study treatment to the first documentation of major response.	Up to approximately 5 years
All Cohorts: Time to major response as assessed by the investigator	Time to major response is defined as the time from start of study treatment to the first documentation of major response.	Up to approximately 5 years
Cohorts 1, 2, and 3: Overall Survival (OS)	OS is defined as the time from first study drug administration to the date of death due to any cause.	Up to approximately 5 years
Time to next treatment in cohort 4	Defined as the time from the start of treatment to the start of first subsequent therapy for WM.	Up to approximately 5 years
Number of participants reporting adverse events	Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities, physical examination results, and vital signs.	Up to approximately 5 years
Health-Related Quality of Life (HRQoL): NFLymSI-18	HRQoL based on participant-reported outcomes using National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy Lymphoma Cancer Symptom Index - 18 Item (NFLymSI-18) Version 4. The questionnaire contains 18 items, each of which utilizes a Likert scale with 5 possible responses ranging from 0 'Not at all' to 4 'Very much' and is divided into a total score.	Up to approximately 5 years

Frequently Asked Questions

Please note: some questions and answers are submitted by anonymous patients or using AI, and have not been verified by Clinrol

No questions submitted. Be the first to ask a question!

You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

Clinical Trials Gov: Study to Evaluate the Efficacy and Safety of Sonrotoclax in Participants With Waldenström's Macroglobulinemia