OncoMatch/Clinical Trials/NCT07885397
Sonrotoclax Plus Azacitidine in Patients With MDS-IB2
Official title: A Multicenter, Open-Label, Single-Arm Phase Ib/II Study of the Safety and Efficacy of Sonrotoclax in Combination With Azacitidine in Patients With Myelodysplastic Neoplasms With Increased Blasts-2 (MDS-IB2)
Is NCT07885397 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1/2 trial studies multiple treatments including Sonrotoclax and Azacitidine (AZA) for myelodysplastic syndromes, high risk.
Treatment: Sonrotoclax · Azacitidine (AZA) — 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 control group. Participants will undergo regular blood tests, bone marrow examinations, and monitoring for side effects. Suitable participants may proceed to transplantation based on disease response and clinical condition. Those who are not proceeding to transplantation and continue to benefit may continue treatment according to the protocol. Follow-up will assess the duration of remission, disease progression, subsequent treatment, survival, and quality of life.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Myelodysplastic Syndrome
Disease stage
Required: Stage MDS-IB2 (other)
Excluded: Stage ACUTE MYELOID LEUKEMIA
MDS-IB2 according to the current World Health Organization (WHO) diagnostic criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: chemotherapy
Cannot have received: bcl-2 inhibitor (sonrotoclax)
Lab requirements
Kidney function
creatinine clearance ≥40 ml/min
Liver function
total bilirubin ≤1.5 × uln; alt and ast ≤3 × uln
Cardiac function
left ventricular ejection fraction (lvef) ≥50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07885397 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
What disease stage is eligible?
Stage MDS-IB2 is required.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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