Sonrotoclax plus azacitidine in high-risk MDS with increased blasts-2

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 multicenter, open-label study has two parts. Phase Ib will explore different doses of sonrotoclax to establish a recommended dose for Phase II. Phase II will assess the combination’s ability to induce remission and monitor safety at the chosen dose. All participants receive the same treatment (sonrotoclax plus azacitidine) without a randomized control group, with regular blood tests and bone marrow assessments to track response and safety.

Why it matters

Who can join: the full rules

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.

Where it's running

• Shanghai General Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Huashan Hospital, Fudan University
  Shanghai, Shanghai Municipality, China Not yet recruiting
• Shanghai Jiading District Central Hospital
  Shanghai, China Not yet recruiting
• Shanghai Minhang District Central Hospital
  Shanghai, China Not yet recruiting
• Shanghai Qingpu District Central Hospital
  Shanghai, China Not yet recruiting
• Xinhua Hospital, Shanghai Jiao Tong University
  Shanghai, China Not yet recruiting

Study contacts

• Study coordinator: Xianmin Song, MD
• Email: shongxm@sjtu.edu.cn
• Phone: +86 13501672508

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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.