B-cell malignancies MedDRA version: 20.0 Level: LLT Classification code 10003901 Term: B-cell lymphoma NOS System Organ Class: 100000004864
Conditions
Interventions
Product Name: Zanubrutinib
Product Code: [BGB-3111]
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Zanubrutinib
CAS Number: 1691249-45-2
Current Sponsor code: BGB-3111
Concentration unit: mg
Sponsors
BeiGene Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. As part of a BeiGene parent study: a. Currently participating, or b. Participated recently 2. Intent to continue or start zanubrutinib treatment after occurrence of any of the following: a. At time of final analysis or study closure of the eligible BeiGene parent study: •For zanubrutinib-naive patients, rationale for initiation of zanubrutinib treatment must be discussed with and approved by the medical monitor b. At time of progressive disease (PD) after occurrence of either of the following: i Patient was receiving zanubrutinib at the time of progressive disease (PD), and the investigator and patient agree it is in the patient's best interest to continue zanubrutinib (discussion with and approval by the medical monitors of the parent study and this study required) ii Patient was receiving a non-BTK inhibitor drug at the time of progressive disease (PD), and the investigator and patient agree that the patient may clinically benefit from zanubrutinib treatment (discussion with and approval by the medical monitors of the parent study and this study required) c. At an alternative timepoint for an alternative reason (discussion with and approval by the medical monitor required) 3. Patient who is currently on zanubrutinib treatment: Does not meet any criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 422 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 78
Exclusion criteria
Exclusion criteria: 1. Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent 2. Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy 3. Life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk 4. Concomitant chemotherapy, targeted therapy, radiation therapy,antibody-based therapy, or any prohibited concomitant therapy outlined in the protocol 5. Pregnant or lactating woman 6. Inability to comply with study procedures 7. Concurrent participation in another therapeutic clinical study 8. History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the long-term safety of zanubrutinib, as monotherapy or in combination, in patients with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib;Secondary Objective: To evaluate the long-term efficacy of zanubrutinib, as monotherapy or in combination, by measuring the following: - Progression-free survival (PFS) - Duration of response (DOR) - Overall survival (OS);Primary end point(s): The primary endpoint of the study is safety as assessed by incidence of all TEAEs and SAEs.;Timepoint(s) of evaluation of this end point: on or after the first dose of study drug up to 30 days after the last dose of study drug or initiation of new antineoplastic therapy, whichever comes first | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • PFS in base alla valutazione dello sperimentatore • DOR in base alla valutazione dello sperimentatore • OS;Timepoint(s) of evaluation of this end point: - the time from the starting date of zanubrutinib to the date of first documentation of PD or death, whichever occurs first - the time from the date that the response criteria are first met after the start of zanubrutinib to the date that PD is documented or death - the time from the starting date of zanubrutinib to the date of death due to any reason | — |
Countries
Australia, China, Italy, Korea, Democratic People's Republic of, Korea, Republic of, New Zealand, United Kingdom, United States
Contacts
Public ContactBeiGene Clinical Support
BeiGene, Ltd.
Outcome results
None listed