BGB-3111-LTE1

JRCT ID: jRCT2011240032

Registered date:17/09/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: B-cell malignancies
• Date of first enrollment: 01/10/2024
• Target sample size: 5
• Countries of recruitment: China,Japan,Czechia,Japan,France,Japan,Greece,Japan,Italy,Japan,Republic of Korea,Japan,Netherlands,Japan,Poland,Japan,Spain,Japan,Sweden,Japan,Turkey,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): The majority of patients will receive zanubrutinib as the only investigational product. The total dose is 320 mg daily, given either as 160 mg twice daily or 320 mg once daily.

Outcome(s)

• Primary Outcome: Incidence of all treatment-emergent adverse events (AEs) and serious adverse events (SAEs), according to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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:
- At time of final analysis or study closure of the eligible BeiGene parent study
- At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest
- 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/mm^3
2) Absolute neutrophil count >= 750/mm^3
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.

Exclude 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)

Related Information

• Primary Sponsor: Mogi Koichi