A Phase 3, Open-Label, Randomized Study of Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Obinutuzumab in Patients With Previously Untreated Chronic Lymphocytic Leukemia

Overview

Sponsor-declared trial summary

Key facts

Sponsor

BeOne Medicines AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

5 Apr 2024 → ongoing

Decision date (initial)

2024-03-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2023-506948-17-00

ClinicalTrials.gov

NCT06073821

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Cohort 1: To compare efficacy between Arm A (sonrotoclax plus zanubrutinib [SZ]) versus Arm B (venetoclax plus obinutuzumab [VO]), as measured by progression-free survival (PFS) determined by independent review committee (IRC).
Intermediate (Cohort 1): To compare the rate of undetectable minimal residual disease (uMRD) among patients enrolled to Arm A versus Arm B.

Secondary objectives 2

1. Cohort 1: To compare the rate of complete response (complete response [CR]/complete response with incomplete hematopoietic recovery [CRi]) among patients enrolled to Arm A versus Arm B.
2. Cohort 1: To compare the rate of overall survival (OS) among patients enrolled to Arm A versus Arm B.

Conditions and MedDRA coding

Previously Untreated Chronic Lymphocytic Leukemia

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. Patients aged ≥ 18 years will have a confirmed diagnosis of CLL, based on Hallek et al 2018, requiring treatment as defined by ≥ 1 of the following: progressive bone marrow failure; massive, progressive, or symptomatic splenomegaly; massive, progressive, or symptomatic lymphadenopathy; progressive lymphocytosis with rapid doubling time; symptomatic or functional extranodal involvement; and/or constitutional symptoms.

Exclusion criteria 1

1. Eligible patients must have ≥ 1 measurable lymph node based on computed tomography/magnetic resonance imaging and no prior systemic treatment for CLL; no history of or known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation at time of consideration for study; no ongoing clinically significant cardiovascular disease; and no active infection including hepatitis B or C virus or HIV. Patients who require treatment with warfarin or other vitamin K antagonists will be excluded.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Cohort 1: PFS, defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by IRC.
2. Intermediate (Cohort 1): Undetectable minimal residual disease at < 10^-4 sensitivity (uMRD4) rate at the first Post-treatment Follow-up (PTFU1) Visit based on next-generation sequencing (NGS [clonoSEQ]).

Secondary endpoints 2

1. Cohort 1: Overall complete response rate (CRR) defined as the proportion of patients that achieved best response of CR/CRi, determined by IRC.
2. Cohort 1: OS, defined as time from the date of enrollment to the date of death because of any cause

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 5

Comparator 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

BeOne Medicines AG

Sponsor organisation

BeOne Medicines AG

Address

Aeschengraben 27

City

Basel

Postcode

4051

Country

Switzerland

Scientific contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medical Officer

Public contact point

Organisation

BeOne Medicines AG

Contact name

BeOne Medical Officer

Third parties 23

Locations

9 EU/EEA countries · 55 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 164 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

19 submissions — initial application plus substantial / non-substantial modifications