Trial Title:
Study to Evaluate the Efficacy and Safety of Sonrotoclax in Participants With Waldenström's Macroglobulinemia
NCT ID:
NCT05952037
Condition:
Waldenstrom Macroglobulinemia
Waldenstrom's Macroglobulinemia Recurrent
Waldenstrom's Macroglobulinemia Refractory
Conditions: Official terms:
Waldenstrom Macroglobulinemia
Zanubrutinib
Conditions: Keywords:
Waldenström's macroglobulinemia
Waldenstrom's Macroglobulinemia Recurrent
Waldenstrom's Macroglobulinemia Refractory
Lymphoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
BGB-11417
Description:
Administered orally as a tablet.
Arm group label:
Cohort 1
Arm group label:
Cohort 2
Arm group label:
Cohort 3
Arm group label:
Cohort 4
Other name:
Sonrotoclax
Intervention type:
Drug
Intervention name:
Zanubrutinib
Description:
Administered orally as a tablet.
Arm group label:
Cohort 4
Other name:
BRUKINSA
Other name:
BGB-3111
Summary:
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.
Detailed description:
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.
Criteria for 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).
- 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.
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Colorado Blood Cancer Institute
Address:
City:
Denver
Zip:
80218
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Facility:
Name:
Huntsman Cancer Institute
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Facility:
Name:
Concord Repatriation General Hospital
Address:
City:
Concord
Zip:
2139
Country:
Australia
Status:
Recruiting
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford PK
Zip:
5042
Country:
Australia
Status:
Recruiting
Facility:
Name:
Monash Health
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450000
Country:
China
Status:
Recruiting
Facility:
Name:
Institute of Hematology and Hospital of Blood Disease
Address:
City:
Tianjin
Zip:
300020
Country:
China
Status:
Recruiting
Facility:
Name:
Chu Clermont Ferrand Therapie Cellulaire and Hematolo
Address:
City:
Clermont Ferrand
Zip:
63003
Country:
France
Status:
Recruiting
Facility:
Name:
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Address:
City:
Milano
Zip:
20162
Country:
Italy
Status:
Recruiting
Facility:
Name:
Irccs Policlinico San Matteo, Universita Degli Studi Di Pavi
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Churchill Hospital Oxford University Hospital Nhs Trust
Address:
City:
Headington
Zip:
OX3 7LE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
St Jamess University Hospital
Address:
City:
Leeds
Zip:
LS9 7TF
Country:
United Kingdom
Status:
Recruiting
Start date:
September 28, 2023
Completion date:
September 2028
Lead sponsor:
Agency:
BeiGene
Agency class:
Industry
Source:
BeiGene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05952037
