Ireland
--:--IST
Recruiting Phase 1/2

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

NCT06697184 · tracked via the Priya Life Science UK tracker
Phase
Phase 1/2
Started
2025-01-23
Last updated
2026-10-26

Condition(s) studied

Chronic Lymphocytic LeukemiaCLLMantle Cell LymphomaMCL

Investigational drug(s) / intervention(s)

Sonrotoclax →Zanubrutinib →

Sonrotoclax: Administered orally

Zanubrutinib: Administered orally

Study summary

The purpose of this study is to establish the safety of novel dosing and ramp-up schedules for sonrotoclax in participants with hematological malignancies.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Stable Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2. 2. Adequate organ function and no very recent transfusion or blood growth factor 3. Participants of childbearing potential must be willing to use a highly effective method of birth control and refrain from egg donation for the duration of the study and for ≥ 7 days after the last dose of sonrotoclax or 1 month after the last dose of zanubrutinib, whichever is later. Only for participants with Chronic Lymphocytic Leukemia (CLL): 4. Confirmed diagnosis of CLL, based on Hallek et al 2018, and requiring treatment due to certain features of their disease 5. At least 1 measurable lesion based on computed tomography (CT)/magnetic resonance imaging (MRI) and no history of prolymphocytic leukemia or Richter's transformation. Only for participants with Mantle cell lymphoma (MCL): 6. Historically confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HEAM5) or based on International Consensus Classification (ICC). 7. Relapsed or refractory to the last line of therapy and have received at least 1 prior line of systemic therapy. Note: A line of therapy is considered ≥ 2 consecutive cycles of a systemic anticancer regimen. Patients with prior BTKi therapy should not have progressed during treatment or relapsed within 12 months after BTKi discontinuation. 8. Measurable disease defined as ≥ 1 nodal lesion that is \> 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is \> 1 cm in longest diameter. Exclusion Criteria: 1. Participants unable to comply with the requirements of the protocol 2. Serologic status reflecting active viral hepatitis B virus (HBV) or hepatitis C virus (HCV) infection 3. Positive HIV serology (HIVAb) status unless certain conditions are met. 4. Participants with any major surgical procedure ≤ 28 days before first dose of study treatment 5. Prior systemic treatment for the CLL 6. Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia requiring treatment 7. Prior exposure to a BCL-2 inhibitor NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcome measure(s)

  • Number of Participants who Experience Tumor Lysis Syndrome (TLS) — Up to approximately 4 months
    TLS will be defined by Howard criteria during the schedule-limiting toxicity (SLT) evaluation window

Trial sites (22)

FacilityCityRegionStatus
Moffitt Cancer Center Tampa Florida Recruiting
Fort Wayne Medical Oncology and Hematology Fort Wayne Indiana Recruiting
The University of Kansas Cancer Center Westwood Kansas Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Fred Hutchinson Cancer Research Center Seattle Washington Recruiting
Blacktown Cancer and Haematology Centre Blacktown New South Wales Recruiting
Genesiscare St Andrews Adelaide South Australia Recruiting
Cabrini Hospital Malvern Malvern Victoria Recruiting
The Alfred Hospital Melbourne Victoria Recruiting
Rockingham Hospital Cooloongup Western Australia Recruiting
Linear Clinical Research Nedlands Western Australia Recruiting
Hcfmusp Pesquisa Clinica Do Servico de Hematologia E Terapia Celular São Paulo Brazil Recruiting
Hospital Santa Rita de Cassia Afecc Vitória Brazil Recruiting
Peking University Third Hospital Beijing Beijing Municipality Recruiting
Nanfang Hospital, Southern Medical University Guangzhou Guangdong Recruiting
The First Affiliated Hospital of Soochow University Suzhou Jiangsu Recruiting
Chu Dijon Dijon France Recruiting
Chu Montpellier Hopital Saint Eloi Montpellier France Recruiting
Iuct Oncopole Toulouse France Recruiting
Queen Elizabeth Hospital Birmingham United Kingdom Recruiting
St Jamess University Hospital Leeds United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06697184 on ClinicalTrials.gov ↗ ← All trials in the UK