An unblinded, multi-center study evaluating long-term treatment with Zanubrutinib (BGB-3111) regimens in patients with blood cancer in the lymph nodes
- Conditions
- B-cell malignanciesMedDRA version: 20.0Level: LLTClassification code 10003901Term: B-cell lymphoma NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-000547-31-PL
- Lead Sponsor
- BeiGene, Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 700
1. As part of a BeiGene-sponsored 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-sponsored parent study.
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 (following discussion with the medical
monitor or designee of the parent study and this study) *The following signs and symptoms may be indicators of non-clinically significant progression warranting continued use of zanubrutinib despite
radiologic progression: absence of clinical symptoms and signs of disease progression (including clinically significant worsening of laboratory values), stable Eastern Cooperative Oncology Group Performance Scale (ECOG PS), absence of rapid progression of disease or of progressive tumor at critical anatomical sites that requires urgent alternative medical intervention. In these scenarios, investigators must inform patients that continuing treatment is not considered standard in the treatment of cancer but that in the opinion of the investigator, the patient will continue to benefit from zanubrutinib.
ii. Patient was receiving a non-BTK inhibitor drug at the time of PD, and the investigator and patient agree that the patient may clinically benefit from zanubrutinib treatment (following discussion with the medical
monitor or designee of the parent study and this study)
c. At an alternative timepoint for an alternative reason not described in Inclusion Criteria 2a and 2b (following discussion with the medical monitor or designee)
3. In the opinion of the investigator, the patient will continue to benefit from, and tolerate zanubrutinib
a. Patient who is currently on zanubrutinib treatment:
Does not meet any criteria for zanubrutinib hold or permanent discontinuation
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 154
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 546
1. Permanently discontinued from zanubrutinib treatment in the BeiGene-sponsored 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)
9. Vaccination with a live vaccine within 35 days prior to first dose of study drug
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety of zanubrutinib regimens 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 regimens by measuring the following:<br>- Progression-free survival (PFS)<br>- Duration of response (DOR)<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): - PFS per investigator assessment<br>- DOR per investigator assessment<br>- 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<br>- 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<br>- the time from the starting date of zanubrutinib to the date of death due to any reason