Status:
ACTIVE_NOT_RECRUITING
Study of Bcl-2 Inhibitor Sonrotoclax (BGB-11417) in Participants With Mature B-Cell Malignancies
Lead Sponsor:
BeiGene
Conditions:
Mature B-Cell Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine the safety, tolerability; and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of t...
Eligibility Criteria
Inclusion
- Key
- Confirmed diagnosis of one of the following:
- NHL Cohorts:
- MZL i. R/R extranodal, splenic, or nodal MZL defined as disease that relapsed after, or was refractory to, at least one prior therapy ii. Active disease requiring treatment
- FL i. R/R FL (Grade 1, 2 or 3a based on the WHO 2008 classification of tumors of hematopoietic and lymphoid tissue) and defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy
- DLBCL i. R/R DLBCL (including all subtypes of DLBCL) defined as disease that relapsed after, or was refractory to, at least two prior systemic therapies and has either progressed following or is not a candidate for autologous stem cell transplant (due to comorbidities or non-responsiveness to salvage chemotherapy)
- Transformed indolent B-cell NHL i. Any lymphoma otherwise eligible for Part 1 that has transformed into a more aggressive lymphoma. Patients with transformation from CLL or SLL (Richter's transformation) are not eligible for Part 1
- CLL/SLL Cohorts:
- CLL/SLL diagnosis that meets the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria i. Disease characterized as Treatment Naive (TN) or R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy ii. Requiring treatment as defined by history
- MCL cohorts:
- WHO-defined MCL i. R/R MCL defined as disease that relapsed after, or was refractory to, at least 1 prior systemic therapy; ii. Requiring treatment in the opinion of the investigator
- WM cohorts:
- g. WHO-defined WM (clinical and definitive histologic diagnosis) i. R/R disease defined as disease that relapsed after, or was refractory to, at least 1 prior therapy; ii. Meeting at least 1 criterion for treatment according to consensus panel criteria from the Seventh International Workshop on Waldenström's Macroglobulinemia (Dimopoulos et al 2014)
- Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI), defined as:
- CLL: at least 1 lymph node \> 1.5 cm in longest diameter and measurable in 2 perpendicular dimensions or clonal lymphocytes measured by flow cytometry
- DLBCL, FL, MZL, MCL, or SLL: at least 1 lymph node \> 1.5 cm in longest diameter OR 1 extranodal lesion \> 1.0 cm in the longest diameter, measurable in at least 2 perpendicular dimensions. For MZL, isolated splenomegaly is considered measurable for this study
- WM: serum immunoglobulin (Ig) M level \> 0.5 g/dL
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Adequate organ function
- Adequate pancreatic function indicated by:
- Serum amylase ≤ 1.5 x upper limit of normal (ULN)
- Serum lipase ≤ 1.5 x ULN
- Key
Exclusion
- Known current central nervous system involvement by lymphoma/leukemia
- Known plasma cell neoplasm, prolymphocytic leukemia, history of or currently suspected Richter's syndrome
- Prior therapy ≥ 2 months with or progression on a B-cell lymphoma-2 (Bcl-2) inhibitor
- NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Key Trial Info
Start Date :
March 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 30 2027
Estimated Enrollment :
437 Patients enrolled
Trial Details
Trial ID
NCT04277637
Start Date
March 24 2020
End Date
August 30 2027
Last Update
February 17 2025
Active Locations (44)
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1
UCLA Hematologyoncology
Los Angeles, California, United States, 90095
2
Northwestern University
Chicago, Illinois, United States, 60611
3
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States, 66160
4
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114