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

RECRUITINGPhase 1/2Sponsored by BeOne Medicines
Actively Recruiting
PhasePhase 1/2
SponsorBeOne Medicines
Started2025-01-23
Est. completion2029-11-30
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations6 sites
View on ClinicalTrials.gov →

NCT06697184

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

Age: 18 Years+Healthy volunteers accepted
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.

Conditions5

CLLCancerChronic Lymphocytic LeukemiaMCLMantle Cell Lymphoma

Interventions2

SonrotoclaxZanubrutinib

Locations6 sites

Moffitt Cancer Center
Tampa, Florida, 33612-9496
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
The University of Kansas Cancer Center
Westwood, Kansas, 66205-2003
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5418
Washington University School of Medicine
St Louis, Missouri, 63110-1010

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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