BGB-3111-LTE1 - An Open-label, Multi-center, Monotherapy, Long-term Extension Study of Zanubrutinib (BGB-3111) in Patients with B-cell Malignancies.

Studio Clinico

Patologia: Neoplasie ematologiche

Osservazionale-Sperimentale: Sperimentale

Monocentrico-Multicentrico: Multicentrico

Randomizzato: No

Fase di studio: Non applicabile

Linee di trattamento: Non applicabile

Criteri di inclusione: 

1. Currently participating or participated recently in a BeiGene parent study
2. Intent to continue or start zanubrutinib treatment after any of the following:
    a. At time of final analysis or study closure of the eligible BeiGene parent study
    b. At time of progressive disease (PD); and investigator, patient and medical monitor agree it is in the patient's best interest
    c. 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:
    a. Platelets ≥ 50,000/mm3
    b.Absolute neutrophil count ≥ 750/mm3
    c. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x upper limit of normal
    d. Serum total bilirubin ≤ 3 x upper limit of normal (not required for Gilbert Syndrome)
    e. QT interval corrected for heart rate using Fridericia's formula (QTcF) ≤ 480 msec
    f. No known New York Heart Association (NYHA) Class III or IV congestive heart failure
    g.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.

Criteri di esclusione: 

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.

Trattamento sperimentale: 

Zanubrutinib (BGB-3111).

Trattamento di controllo: 

NA

Obiettivi primari dello studio: 

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.

Centri partecipanti

Nord Italia

Centro Italia

Informazioni Generali

Protocollo

Numero di iscrizione a registro: 2024-511267-28-00 - NCT04170283

Data di inserimento: 24.05.2024

Promotore

BeiGene

Principal Investigator ITALIA

Riferimento: Dr. Info non disponibile

Telefono: 00000

Email: nd@nd.it

Localita: nd