An unblinded, multi-center study evaluating long-term treatment with Zanubrutinib (BGB-3111) regimens in patients with blood cancer in the lymph node
- Conditions
- B-cell malignancies
- Registration Number
- 2024-511267-28-00
- Lead Sponsor
- Beigene Ltd.
- Brief Summary
To evaluate the long-term safety of zanubrutinib regimens in patients with B-cell malignancies who participated in a BeiGene parent study for zanubrutinib
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised, recruiting
- Sex
- Not specified
- Target Recruitment
- 343
As part of a BeiGene-sponsored parent study: a. Currently participating, or b. Participated recently
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)
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
Permanently discontinued from zanubrutinib treatment in the BeiGene-sponsored parent study due to unacceptable toxicity, noncompliance with study procedures, or withdrawal of consent
Uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy
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
Concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapy, or any prohibited concomitant therapy outlined in the protocol
Pregnant or lactating woman
Inability to comply with study procedures
Concurrent participation in another therapeutic clinical study
History of progressive disease (PD) while receiving a BTK inhibitor (excluding zanubrutinib)
Vaccination with a live vaccine within 35 days prior to first dose of study drug
Study & Design
- Study Type
- Not specified
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint of the study is safety as assessed by incidence of all TEAEs and SAEs. The primary endpoint of the study is safety as assessed by incidence of all TEAEs and SAEs.
- Secondary Outcome Measures
Name Time Method Progression-free Survival per investigator assessment Progression-free Survival per investigator assessment
Duration of Response per investigator assessment Duration of Response per investigator assessment
Overall Survival Overall Survival
Trial Locations
- Locations (47)
SRH Kliniken Landkreis Sigmaringen GmbH
🇩🇪Sigmaringen, Germany
Albert Schweitzer Ziekenhuis
🇳🇱Dordrecht, Netherlands
Universitair Medisch Centrum Utrecht
🇳🇱Utrecht, Netherlands
Amsterdam UMC Stichting
🇳🇱Amsterdam, Netherlands
Azienda Ospedaliera S Maria Di Terni
🇮🇹Terni, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milan, Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita
🇮🇹Novara, Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
🇮🇹Bologna, Italy
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
🇮🇹Turin, Italy
Azienda Sanitaria Universitaria Friuli Centrale
🇮🇹Udine, Italy
Scroll for more (37 remaining)SRH Kliniken Landkreis Sigmaringen GmbH🇩🇪Sigmaringen, GermanyGabriele KäferSite contact+4975711000xxx@srh.de