E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
blood cancer in the lymph nodes |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003901 |
E.1.2 | Term | B-cell lymphoma NOS |
E.1.2 | System Organ Class | 100000004864 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the long-term safety of zanubrutinib, as monotherapy or in
combination, in patients with B-cell malignancies who participated in a
BeiGene parent study for zanubrutinib |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the long-term efficacy of zanubrutinib, as monotherapy or in
combination, by measuring the following:
- Progression-free survival (PFS)
- Duration of response (DOR)
- Overall survival (OS) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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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 |
|
E.4 | Principal 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) |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is safety as assessed by incidence of
all TEAEs and SAEs. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
on or after the first dose of study drug up to 30 days after the last dose
of study drug or initiation of new antineoplastic therapy, whichever
comes first |
|
E.5.2 | Secondary end point(s) |
- PFS per investigator assessment
- DOR per investigator assessment
- OS |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
- the time from the starting date of zanubrutinib to the date of first
documentation of PD or death, whichever occurs first
- the time from the date that the response criteria are first met after the
start of zanubrutinib to the date that PD is documented or death
- the time from the starting date of zanubrutinib to the date of death due
to any reason |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 42 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 42 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
China |
Korea, Republic of |
New Zealand |
United States |
France |
Germany |
Greece |
Italy |
Netherlands |
Poland |
Spain |
Sweden |
United Kingdom |
Czechia |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |