Non Hodgkin Lymphoma Clinical Trial
Study of Bcl-2 Inhibitor BGB-11417 in Participants With Mature B-Cell Malignancies
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.
Key Inclusion Criteria:
Confirmed diagnosis of one of the following:
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 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
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
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) 2.
Measurable disease by computed tomography (CT)/magnetic resonance imaging (MRI), defined as:
a. 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 b. 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
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 4. Adequate organ function 5.
Adequate pancreatic function indicated by:
Serum amylase ≤ 1.5 x upper limit of normal (ULN)
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.
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There are 21 Locations for this study
Stanford California, 94305, United States
Boston Massachusetts, 02114, United States
Hackensack New Jersey, 07601, United States
New York New York, 10032, United States
New York New York, 10065, United States
Columbus Ohio, 43210, United States
Houston Texas, 77030, United States
Seattle Washington, 98109, United States
Darlinghurst New South Wales, 2010, Australia
Tugun Queensland, 4224, Australia
Adelaide South Australia, , Australia
East Melbourne Victoria, 3002, Australia
Adelaide , 5042, Australia
Benowa , 4217, Australia
Clayton , 3168, Australia
Concord , 2139, Australia
Melbourne , 3000, Australia
Nedlands , 6009, Australia
Orange , 2800, Australia
Takapuna Auckland, , New Zealand
Grafton Aukland, , New Zealand
Newtown , 6021, New Zealand
Barcelona , 08035, Spain
Barcelona , 08035, Spain
Barcelona , , Spain
Madrid , 28040, Spain
Salamanca , , Spain
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