Non Hodgkin Lymphoma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Key Inclusion Criteria:

1.

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 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

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 investigatorr

WM cohorts:

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.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

418

Study ID:

NCT04277637

Recruitment Status:

Recruiting

Sponsor:

BeiGene

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There are 21 Locations for this study

See Locations Near You

Stanford University
Stanford California, 94305, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
John Theurer Cancer-Hackensack University
Hackensack New Jersey, 07601, United States
Columbia University Medical Center
New York New York, 10032, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
The James Cancer Hospital and Solove Research Institute
Columbus Ohio, 43210, United States
MD Anderson Cancer Center
Houston Texas, 77030, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
St Vincent's Hospital Sydney (Kinghorn)
Darlinghurst New South Wales, 2010, Australia
John Flynn Private Hospital
Tugun Queensland, 4224, Australia
Royal Adelaide Hospital
Adelaide South Australia, , Australia
St Vincent's Hospital Melbourne
East Melbourne Victoria, 3002, Australia
Flinders Medical Centre
Adelaide , 5042, Australia
Pindara Private Hospital
Benowa , 4217, Australia
Monash Medical Centre
Clayton , 3168, Australia
Concord Repatriation General Hospital
Concord , 2139, Australia
Peter McCallum Cancer Center
Melbourne , 3000, Australia
Linear Clinical Research
Nedlands , 6009, Australia
Orange Health Service
Orange , 2800, Australia
North Shore Hospital
Takapuna Auckland, , New Zealand
Auckland City Hospital
Grafton Aukland, , New Zealand
Wellington Hospital
Newtown , 6021, New Zealand
ICO H Duran I Reynals
Barcelona , 08035, Spain
Vall D Hebron Institute of Oncology
Barcelona , 08035, Spain
Hospital Clinic de Barcelona
Barcelona , , Spain
Start Madrid-Fundacion Jimenez Diaz
Madrid , 28040, Spain
Hospital Universitario de Salamanca
Salamanca , , Spain

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

418

Study ID:

NCT04277637

Recruitment Status:

Recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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