Clinical Trials in the UK / NCT06697184
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
Condition(s) studied
Chronic Lymphocytic LeukemiaCLLMantle Cell LymphomaMCL
Investigational drug(s) / intervention(s)
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
On this site
📄 Brukinsa (zanubrutinib) drug profile →More BeOne Medicines trials in the UK
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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