Investigating a new dosing schedule for sonrotoclax in blood cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the safety of novel dosing and ramp-up schedules for the experimental drug sonrotoclax in patients with chronic lymphocytic leukemia (CLL). The approach involves gradually increasing the dose of sonrotoclax over specified periods to reach the target daily dose while monitoring for tumor lysis syndrome and related toxicities. Initially, small groups of participants will test each dosing schedule for safety, followed by a larger group to further assess the approved schedules. The goal is to optimize the dosing regimen to enhance patient outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Moffitt Cancer Center
  Tampa, Florida, United States Recruiting
• Fort Wayne Medical Oncology and Hematology
  Fort Wayne, Indiana, United States Recruiting
• The University of Kansas Cancer Center
  Westwood, Kansas, United States Recruiting
• Dana Farber Cancer Institute
  Boston, Massachusetts, United States Recruiting
• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting
• Fred Hutchinson Cancer Research Center
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Study Director
• Email: clinicaltrials@beonemed.com
• Phone: 1.877.828.5568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.