Non Hodgkin Lymphoma Clinical Trial

A Phase 1 Dose-Escalation and Expansion Study of BGB-16673 in Patients With B-Cell Malignancies

Summary

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)

View Eligibility Criteria

Eligibility Criteria

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, FL, MCL, CLL/SLL, or WM.
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.
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; patients with CLL/SLL or MCL enrolling in the expansion cohorts must have been treated with a BTKi in a prior line of therapy.

Exclusion Criteria:

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, or history of or currently suspected Richter's transformation.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

76

Study ID:

NCT05006716

Recruitment Status:

Recruiting

Sponsor:

BeiGene

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There are 12 Locations for this study

See Locations Near You

5777 E. Mayo Boulevard
Phoenix Arizona, 85004, United States
The University of Arizona Cancer Center
Tucson Arizona, 85724, United States
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States
Norton Cancer Institute, St. Matthews Campus
Louisville Kentucky, 40207, United States
Mayo Clinic (Rochester)
Rochester Minnesota, 55905, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
The University of Texas, MD Anderson Cancer Center
Houston Texas, 77030, United States
Concord Repatriation General Hospital
Concord New South Wales, 2139, Australia
Peter MacCallum Cancer Institute
Melbourne Victoria, 3000, Australia
The Alfred Hospital
Melbourne Victoria, 3004, Australia
Perth Blood Institute
West Perth Western Australia, 6005, Australia
Linear Clinical Research
Nedlands , 6009, Australia

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

76

Study ID:

NCT05006716

Recruitment Status:

Recruiting

Sponsor:


BeiGene

How clear is this clinincal trial information?

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