💬In plain words
What the trial is, and whether it could suit you
This study will evaluate the safety and preliminary effectiveness of sonrotoclax combined with azacitidine in adults aged 18-70 years with newly diagnosed myelodysplastic neoplasms with increased blasts-2 (MDS-IB2).
Sonrotoclax blocks BCL-2, a protein that helps cancer cells survive. Combining sonrotoclax with azacitidine may improve disease control. This study aims to determine whether the combination can induce remission with an acceptable safety profile, facilitate allogeneic stem cell transplantation in suitable patients, and improve long-term clinical outcomes.
This multicenter, open-label study has two sequential parts. Phase Ib will evaluate different sonrotoclax doses and identify the recommended dose for phase II. Phase II will further assess remission rates and safety at the selected dose. All participants will receive sonrotoclax plus azacitidine; there is no randomized cont
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📋 Eligibility rules (as published)
Inclusion Criteria:
1. Age 18 to 70 years, male or female.
2. Voluntarily willing to participate in the study, able to understand and sign written informed consent, and willing to comply with study treatment, assessments, and follow-up.
3. Newly diagnosed with myelodysplastic syndromes with increased blasts-2 (MDS-IB2) according to the current World Health Organization (WHO) diagnostic criteria.
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
5. Estimated life expectancy of at least 12 weeks.
6. Adequate organ function to tolerate study treatment, including:
1. Total bilirubin ≤1.5 × upper limit of normal (ULN);
2. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 × ULN;
3. Creatinine clearance ≥40 mL/min;
4. Left ventricular ejection fraction (LVEF) ≥50%;
5. Baseline oxygen saturation \>92%.
7. Able to take oral medication and without gastrointestinal disorders that would significantly affect drug absorption.
8. Considered by the investigator to be able to safely receive sonrotoclax initiation and dose ramp-up.
9. Participants of childbearing potential must have a negative pregnancy test and agree to use effective contraception during the study and for the protocol-specified period after the last dose of study treatment.
Exclusion Criteria:
1. Disease already transformed to acute myeloid leukemia (AML).
2. Prior treatment with chemotherapy, sonrotoclax, or other BCL-2 inhibitors.
3. Uncontrolled active infection, including severe bacterial, fungal, or viral infection.
4. Active hepatitis B, hepatitis C, human immunodeficiency virus (HIV) infection, or active tuberculosis that is not adequately controlled.
5. Significant uncontrolled cardiac, hepatic, renal, or other major organ dysfunction that, in the investigator's judgment, would preclude safe study treatment.
6. Active graft-versus-host disease (GVHD) after prior allogeneic hematopoietic stem cell transplantation or ongoing requirement for systemic immunosuppressive therapy.
7. Anticipated need for continuous use of a strong CYP3A inhibitor during sonrotoclax initiation and dose ramp-up that cannot be discontinued or replaced.
8. Uncontrolled high risk of tumor lysis syndrome (TLS) that, in the investigator's judgment, makes the participant unsuitable for sonrotoclax treatment.
9. Pregnant or breastfeeding women.
10. Known severe hypersensitivity to sonrotoclax, azacitidine, or any of their excipients.
11. Concurrent participation in another interventional clinical study without meeting applicable discontinuation requirements.
12. Any other condition that, in the investigator's judgment, makes the participant unsuitable for participation in the study.
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