n estudio multicéntrico no ciego que evalúa el tratamiento a largo plazo con regímenes de zanubrutinib (BGB-3111) en pacientes con cáncer de sangre en los ganglios linfáticos

Phase 1

• Conditions: B-cell malignancies; MedDRA version: 20.0Level: LLTClassification code 10003901Term: B-cell lymphoma NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2020-000547-31-ES
• Lead Sponsor: BeiGene, Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-27
• Last Update Posted: 28 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 700

Inclusion Criteria

1. As part of a BeiGene parent study:
a. Currently participating, or
b. Participated recently

2. 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 parent study:
•For zanubrutinib-naive patients, rationale for initiation of zanubrutinib treatment must be discussed with and approved by the medical monitor
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 (discussion with and approval by the medical monitors of the parent study and this study required)
ii Patient was receiving a non-BTK inhibitor drug at the time of progressive disease (PD), and the investigator and patient agree that the patient may clinically benefit from zanubrutinib treatment (discussion with and approval by the medical monitors of the parent study and this study required)
c. At an alternative timepoint for an alternative reason (discussion with and approval by the medical monitor required)

3. Patient who is currently on zanubrutinib treatment:
Does not meet any criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 154
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 546

Exclusion Criteria

1. Permanently discontinued from zanubrutinib treatment in the BeiGene parent study due to unacceptable toxicity, noncompliance 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 patient'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 therapy, 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified