Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Participants With B-cell Malignancies

BeiGene

Status and phase: Invitation-only; Phase 3

Conditions: B-cell Malignancies

Treatments: Drug: Zanubrutinib; Drug: Tislelizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04170283

BGB-3111-LTE1

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

1. Currently participating or participated recently in a BeiGene parent study

2. Intent to continue or start zanubrutinib treatment after any of the following:

   1. At time of final analysis or study closure of the eligible BeiGene parent study
   2. At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest
   3. At an alternative timepoint for an alternative reason

3. Patient who is currently on zanubrutinib treatment:

   Does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment

4. Zanubrutinib-naive patient:

   Must meet the following criteria ≤ 15 days before first dose of study drug:

   1. Platelets ≥ 50,000/mm3
   2. Absolute neutrophil count ≥ 750/mm3
   3. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
   4. Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome)
   5. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec
   6. No known New York Heart Association (NYHA) Class III or IV congestive heart failure
   7. Creatinine clearance ≥ 30 mL/min

5. Female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control.

Key Exclusion Criteria:

1. Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, non-compliance 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 participant'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 therapies, 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)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Zanubrutinib (BGB-3111)

Experimental group

Description:

All participants to receive open-label zanubrutinib

Treatment:

Drug: Zanubrutinib

Zanubrutinib in combination with Tislelizumab

Experimental group

Description:

Participants to receive the combination as in the parent study (Australia Only)

Treatment:

Drug: Tislelizumab

Drug: Zanubrutinib