Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies

Overview

About this study

The purpose of this study is to determine the safety and tolerability of and to define the maximum tolerated dose (MTD) and Recommended Phase 2 Dose (RP2D); and to evaluate the safety and tolerability of the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Key Inclusion Criteria:

- Confirmed diagnosis of one of the following:

NHL Cohorts:

1. 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

2. 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

3. 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)

4. 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:

5. 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:

6. 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
investigatorr

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:

1. 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

2. DLBCL, FL, MZL, 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

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

- Adequate organ function

- Adequate pancreatic function indicated by:

1. Serum amylase ≤ 1.5 x upper limit of normal (ULN)

2. Serum lipase ≤ 1.5 x ULN

Key Exclusion Criteria:

- Known 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.

Eligibility last updated 5/18/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Paul Hampel, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
.
CLS-20539921

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