A Study to Investigate the Safety of Novel Dose Ramp-up Schedule(s) When Initiating Sonrotoclax in Patients Treated for Blood Cancers

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

2 Jul 2025 → ongoing

Decision date (initial)

2025-04-22

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-518829-15-00

ClinicalTrials.gov

NCT06697184

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Pharmacodynamic, Safety

To evaluate the incidence of TLS in novel dosing/ramp-up schedules

Secondary objectives 2

1. To evaluate the safety and tolerability of novel dosing/ramp-up schedules for sonrotoclax
2. To evaluate the impact of novel dosing/ramp-up schedules on treatment exposure

Conditions and MedDRA coding

previously untreated chronic lymphocytic leukemia (CLL)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. All patients: Age ≥ 18 years
2. CLL patients: • Confirmed diagnosis of CLL, based on Hallek et al 2018, requiring treatment as defined by at least one of the following: progressive bone marrow failure; massive, progressive, or symptomatic splenomegaly; massive, progressive, or symptomatic lymphadenopathy; progressive lymphocytosis with rapid doubling time; and/or constitutional symptoms. • At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter’s transformation. • Previously untreated patients: no prior systemic treatment for the disease under study

Exclusion criteria 1

1. All patients: No ongoing clinically significant cardiovascular disease and no active infection including hepatitis B or C. In case of HIV infection, certain conditions such as CD4 count should be met. Systemic corticosteroids must be discontinued before the date of treatment start.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Incidence and severity of TLS (both laboratory and clinical TLS) as defined by Howard criteria during the SLT evaluation window

Secondary endpoints 2

1. Safety via incidence and severity of treatment-emergent adverse events, serious adverse events, and adverse events according to NCI-CTCAE v5.0; Tolerability as determined by protocol-defined SLTs during the SLT evaluation window
2. Incidence of dose modifications (dose modified, held, or discontinued), during the SLT evaluation window

Investigational products

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

Test 5

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 10

Locations

1 EU/EEA country · 3 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 8 files

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

Application history

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