N-[4-({[(1R,4R)-4-HYDROXY-4-METHYLCYCLOHEXYL]METHYL}AMINO)-3- NITROBENZENE-1-SULFONYL]-4-(2-{(2S)-2-[2-(PROPAN-2-YL)PHENYL]PYRROLIDIN1-YL}-7-AZASPIRO[3.5]NONAN-7-YL)-2-[(1H-PYRROLO[2,3-B]PYRIDIN-5- YL)OXY]BENZAMIDE for Chronic lymphocytic leukemia (CLL)

Inclusion criteria

• {"criterion_text":"- All patients: Age ≥ 18 years"}
• {"criterion_text":"- 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

• {"criterion_text":"- 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."}

Primary endpoints

• {"endpoint_text":"- Incidence and severity of TLS (both laboratory and clinical TLS) as defined by Howard criteria during the SLT evaluation window","definition_or_measurement_approach":"Incidence and severity of TLS (both laboratory and clinical TLS) as defined by Howard criteria during the SLT evaluation window"}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Safety assessed via incidence and severity of treatment-emergent adverse events, serious adverse events, and adverse events according to NCI-CTCAE v5.0; tolerability assessed by protocol-defined SLTs during the SLT evaluation window"}
• {"endpoint_text":"- Incidence of dose modifications (dose modified, held, or discontinued), during the SLT evaluation window","definition_or_measurement_approach":"Count and incidence of dose modifications (modified, held, or discontinued) occurring during the SLT evaluation window"}

France

Earliest CTIS Part Ii Submission Date

06-03-2025

Latest Decision Or Authorization Date

19-11-2025

Processing Time Days

258

Number Of Sites

3

Number Of Participants

14

Primary sponsor

Full Name

BeOne Medicines AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

4g Clinical LLC

Responsibilities

sponsorDuties codes: [3]; contact email: info@4gclinical.com

Name

Medidata Solutions Inc.

Responsibilities

sponsorDuties codes: [7]; contact email: helpdesk@mdsol.com

Name

Scout Clinical

Responsibilities

sponsorDuties codes: [15] (Patient travel reimbursement); contact email: clientcompliance@meetingprotocol.com

Third parties

• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"sponsorDuties codes: [3]; email: info@4gclinical.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"China","full_name":"Wuxi Apptec (Shanghai) Co. Ltd.","duties_or_roles":"sponsorDuties codes: [4]; email: BAS_Logistics@wuxiapptec.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"sponsorDuties codes: [7]; email: helpdesk@mdsol.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"France","full_name":"Quipment","duties_or_roles":"sponsorDuties codes: [14]; email: salesadministration@quipment.fr","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Laboratory Corporation Of America Holdings","duties_or_roles":"sponsorDuties codes: [4]; email: zhen.liu@labcorp.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"sponsorDuties codes: [4]; email: MRDClientmanagers@adaptivebiotech.com","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"MLL Dx GmbH","duties_or_roles":"sponsorDuties codes: [4]; email: studycoordinator@mll.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"sponsorDuties codes: [4]; email: zhen.liu@labcorp.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"sponsorDuties codes: [15] (Patient travel reimbursement); email: clientcompliance@meetingprotocol.com","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"Predicine Inc.","duties_or_roles":"sponsorDuties codes: [4]; email: Pharma.samples@predicine.com","organisation_type":"Hospital/Clinic/Other health care facility"}