An unblinded, multi-center study evaluating long-term treatment with Zanubrutinib (BGB-3111) regimens in patients with blood cancer in the lymph node

Overview

Sponsor-declared trial summary

Key facts

Sponsor

BeOne Medicines AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

17 Feb 2021 → ongoing

Decision date (initial)

2024-03-07

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

BeiGene, Ltd.

External identifiers

EU CT number

2024-511267-28-00

EudraCT number

2020-000547-31

WHO UTN

U1111-1302-6289

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

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 objectives 1

1. To evaluate the long-term efficacy of zanubrutinib regimens by measuring the following: - Progression-free survival - Duration of response - Overall survival

Conditions and MedDRA coding

B-cell malignancies

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

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

Exclusion criteria 9

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint of the study is safety as assessed by incidence of all TEAEs and SAEs.

Secondary endpoints 3

1. Progression-free Survival per investigator assessment
2. Duration of Response per investigator assessment
3. Overall Survival

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

BeOne Medicines AG

Sponsor organisation

BeOne Medicines AG

Address

Aeschengraben 27

City

Basel

Postcode

4051

Country

Switzerland

Scientific contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medical Officer

Public contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medical Officer

Third parties 6

Locations

9 EU/EEA countries · 49 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 105 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

9 submissions — initial application plus substantial / non-substantial modifications