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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2023
  • participants needed
    116
  • sponsor
    BeiGene
Updated on 27 September 2020
Investigator
Eric Hedrick, MD
Primary Contact
Concord REpatriation General Hospital (3.5 mi away) Contact
+3 other location

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 the ramp-up dosing schedule and at the RP2D of BGB-11417 monotherapy, and when given in combination with zanubrutinib.

Details
Treatment BGB-11417
Clinical Study IdentifierNCT04277637
SponsorBeiGene
Last Modified on27 September 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have Mature B-Cell Malignancies?
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 two prior therapies ii. Active disease requiring treatment b. 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 2 prior systemic therapies c. 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) d. 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
e. CLL/SLL diagnosis that meets the International Workshop on Chronic
Lymphocytic Leukemia (IWCLL) criteria i. Disease characterized as R/R disease
defined as disease that relapsed after, or was refractory to, at least 2 prior
therapies ii. Requiring treatment as defined by history
\. 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, 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
Serum amylase 1.5 x upper limit of normal (ULN)
Serum lipase 1.5 x ULN

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
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