臨床研究等提出・公開システム

An Open-label, Multi-center, Long-term Extension Study of Zanubrutinib (BGB-3111) Regimens in Patients With B-Cell Malignancies

BGB-3111-LTE1

Asano Shinichiro

BeOne Medicines Japan

Shiodome City Center, 1-5-2 Higashi Shimbashi, Minato-ku, Tokyo 105-7114, Japan

MedInfoJP@beigene.com

Hamano Fumiaki

BeOne Medicines Japan

Shiodome City Center, 1-5-2 Higashi Shimbashi, Minato-ku, Tokyo 105-7114, Japan

+81-800-919-0351

MedInfoJP@beigene.com

Not Recruiting

Oct. 01, 2024

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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.

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)

Both

B-cell malignancies

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.

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)

+81-11-563-2211

Aug. 01, 2024

No

China/Czechia/France/Greece/Italy/Republic of Korea/Netherlands/Poland/Spain/Sweden/Turkey/United Kingdom/United States