Non Hodgkin Lymphoma Clinical Trial
A Phase 1 Dose-Escalation and Expansion Study of BGB-16673 in Patients With B-Cell Malignancies
Study consists of two parts to explore BGB-16673 recommended dosing, a part 1 monotherapy dose finding and a part 2 (cohort expansion in two cohorts)
Inclusion Criteria :
Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection
Age ≥ 18 years
Confirmed diagnosis (per World Health Organization [WHO] guidelines, unless otherwise noted) of one of the following: MZL (Part 1a and 1b only), FL (Part 1a only), MCL, CLL/SLL, WM (Part 1a and 1b only), DLBCL (Part 1a only), or >2 treatments per the Richter's transformation to DLBCL (Part 1a only).
Patients who have previously received a covalently-binding BTK inhibitor in any line of therapy must have received treatment with the BTK inhibitor for ≥ 8 weeks (unless reason for discontinuation is intolerance).
For dose-finding and dose-expansion, patients who had previously received a covalently-binding BTK inhibitor as monotherapy or in combination with other anticancer agents are eligible for the study if they meet any of the following criteria: discontinued the previous BTK inhibitor due to disease progression, experienced disease progression after completing treatment with a BTK inhibitor or discontinued the BTK inhibitor due to toxicity or intolerance.
Measurable disease by radiographic assessment or serum IgM level (WM only)
ECOG Performance Status of 0 to 2
Patients enrolling in the dose finding phase of the study may be previously treated with a BTKi or may be naïve to BTKi therapy depending on the diagnosis and country of enrollment; patients with CLL/SLL or MCL enrolling in the expansion cohorts (Part 2) must have been treated with a BTKi in a prior line of therapy.
Prior malignancy (other than the disease under study) within the past 2 years, except for curatively treated basal or squamous skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer
Requires ongoing systemic treatment for any other malignancy
Requires ongoing systemic (defined as ≥ 10 mg/day of prednisone or equivalent) corticosteroid treatment.
Current or history of central nervous system involvement including the brain, spinal cord, leptomeninges, and cerebrospinal fluid (as documented by imaging, cytology, or biopsy) by B-cell malignancy, regardless of whether patient had received treatment for central nervous system disease
Known active plasma cell neoplasm, prolymphocytic leukemia, T-cell lymphoma, Burkitt lymphoma, acquired immunodeficiency syndrome (AIDS)-related B-cell lymphoma, Castleman disease, post-transplant lymphoproliferative disorders, hairy cell leukemia, GCB DLBCL, EBV+ DLBCL NOS, primary DLBCL of the central nervous system (CNS), primary cutaneous DLBCL - leg type, DLBCL associated with chronic inflammation, primary mediastinal (thymic) large B-cell lymphoma, intravascular large B-cell lymphoma, ALK+ large B-cell lymphoma, primary effusion lymphoma, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements, high-grade B-cell lymphoma - NOS, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, or history of or currently suspected Richter's transformation of an indolent lymphoma to an aggressive histology (only patients with Richter Transformation to DLBCL are eligible for Part 1a).
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 16 Locations for this study
Phoenix Arizona, 85004, United States
Tucson Arizona, 85724, United States
Los Angeles California, 90067, United States
Santa Monica California, 90404, United States
Jacksonville Florida, 32224, United States
Louisville Kentucky, 40207, United States
Rochester Minnesota, 55905, United States
Omaha Nebraska, 68130, United States
New York New York, 10065, United States
New York New York, 10065, United States
Houston Texas, 77030, United States
Concord New South Wales, 2139, Australia
Fitzroy Victoria, 3065, Australia
Melbourne Victoria, 3000, Australia
Melbourne Victoria, 3004, Australia
West Perth Western Australia, 6005, Australia
Nedlands , 6009, Australia
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