Back to resultsStudy to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia
Primary Purpose
Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory
Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BGB-11417
Sponsored by
About this trial
This is an interventional treatment trial for Waldenstrom Macroglobulinemia focused on measuring Waldenström's macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory, Lymphoma
Eligibility Criteria
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). 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. 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. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sites / Locations
- Hattiesburg Hematology and Oncology ClinicRecruiting
- Genesiscare North ShoreRecruiting
- Princess Alexandra HospitalRecruiting
- Flinders Medical CentreRecruiting
- Monash HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Major Response Rate (MRR) in Cohort 1
MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the Independent Review Committee (IRC).
Secondary Outcome Measures
MRR in Cohorts 1, 2, and 3
MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the investigator (Cohorts 1, 2, and 3) and by the IRC (Cohorts 2 and 3).
Duration of Response (DOR)
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC and by the investigator.
CR + VGPR rate
CR + VGPR is defined as the percentage of participants who achieve CR or VGPR, as assessed by the IRC and by the investigator.
Overall Response Rate (ORR)
ORR is defined as the percentage of participants with minor response (MR) or better, as assessed by the IRC and by the investigator.
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.
Time to major response
Time to major response is defined as the time from start of study treatment to the first documentation of major response, as assessed by the IRC and by the investigator.
Overall Survival (OS)
OS is defined as the time from first study drug administration to the date of death due to any cause.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05952037
Brief Title
Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia
Official Title
An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2023 (Actual)
Primary Completion Date
November 2027 (Anticipated)
Study Completion Date
September 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BeiGene
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.
Detailed Description
This study will test whether BGB-11417 can be used to improve outcomes in participants with Waldenström's Macroglobulinemia (WM) who have not responded well to conventional treatments. 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 85 patients. All patients will receive BGB-11417 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Waldenstrom Macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory
Keywords
Waldenström's macroglobulinemia, Waldenstrom's Macroglobulinemia Recurrent, Waldenstrom's Macroglobulinemia Refractory, Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
85 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
BGB-11417
Other Intervention Name(s)
Sonrotoclax
Intervention Description
Administered orally as a tablet.
Primary Outcome Measure Information:
Title
Major Response Rate (MRR) in Cohort 1
Description
MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the Independent Review Committee (IRC).
Time Frame
Up to approximately 4 years
Secondary Outcome Measure Information:
Title
MRR in Cohorts 1, 2, and 3
Description
MRR is defined as the percentage of participants who achieved complete response (CR), very good partial response (VGPR), or partial response (PR), as assessed by the investigator (Cohorts 1, 2, and 3) and by the IRC (Cohorts 2 and 3).
Time Frame
Up to approximately 5 years
Title
Duration of Response (DOR)
Description
DOR is defined as the time from the date that response criteria are first met to the date that progressive disease is objectively documented or death, whichever comes first, as assessed by the IRC and by the investigator.
Time Frame
Up to approximately 5 years
Title
CR + VGPR rate
Description
CR + VGPR is defined as the percentage of participants who achieve CR or VGPR, as assessed by the IRC and by the investigator.
Time Frame
Up to approximately 5 years
Title
Overall Response Rate (ORR)
Description
ORR is defined as the percentage of participants with minor response (MR) or better, as assessed by the IRC and by the investigator.
Time Frame
Up to approximately 5 years
Title
Progression-Free Survival (PFS)
Description
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.
Time Frame
Up to approximately 5 years
Title
Time to major response
Description
Time to major response is defined as the time from start of study treatment to the first documentation of major response, as assessed by the IRC and by the investigator.
Time Frame
Up to approximately 5 years
Title
Overall Survival (OS)
Description
OS is defined as the time from first study drug administration to the date of death due to any cause.
Time Frame
Up to approximately 5 years
Title
Number of participants reporting adverse events
Description
Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), including laboratory abnormalities, physical examination results, and vital signs.
Time Frame
Up to approximately 5 years
Title
Health-Related Quality of Life (HRQoL): NFLymSI-18
Description
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.
Time Frame
Up to approximately 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
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.
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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Director
Phone
1-877-828-5568
Email
clinicaltrials@beigene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
BeiGene
Official's Role
Study Director
Facility Information:
Facility Name
Hattiesburg Hematology and Oncology Clinic
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39401
Country
United States
Individual Site Status
Recruiting
Facility Name
Genesiscare North Shore
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Individual Site Status
Recruiting
Facility Name
Princess Alexandra Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Individual Site Status
Recruiting
Facility Name
Flinders Medical Centre
City
Bedford PK
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Individual Site Status
Recruiting
Facility Name
Monash Health
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
Country
Australia
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Study to Evaluate the Efficacy and Safety of BGB-11417 in Participants With Waldenström's Macroglobulinemia
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