Sonrotoclax plus azacitidine with targeted agents or chemotherapy for newly diagnosed adult AML

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 open-label, phase II, multi-center trial combines sonrotoclax with azacitidine and individualized targeted agents or anthracycline chemotherapy in adults with newly diagnosed AML. Participants are stratified by FLT3/IDH1 mutation status and fitness for intensive chemotherapy, with fit patients receiving additional daunorubicin or idarubicin and FLT3-mutant patients receiving gilteritinib. Sonrotoclax is given with dose escalation from 20 mg/day up to 320 mg/day followed by maintenance dosing and possible temporary holds, while azacitidine is administered 75 mg/m² on Days 1–7 of each 28-day cycle. Safety and efficacy outcomes, including response rates and tolerability, are collected across treatment arms.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Newly diagnosed AML confirmed by bone marrow morphology and immunophenotyping (5th edition WHO diagnostic criteria)
* Subjects with APL excluded according to fusion gene and chromosome results
* ECOG performance status 0-3
* Age ≥ 18 years
* White blood cell count must be \< 25 × 10⁹/L at the start of study treatment (can be reduced by leukapheresis and/or hydroxyurea)
* Subjects must have adequate organ function, defined as follows: Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN), unless elevated due to leukemic organ involvement; serum total bilirubin \< 3 × ULN; higher levels are acceptable if attributable to ineffective erythropoiesis, leukemic organ involvement, or Gilbert syndrome; serum creatinine \< 3 × ULN, or estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula
* Written informed consent obtained from the subject or legal representative

Exclusion Criteria:

* FAB classification as M3, or molecularly confirmed APL
* Refractory / relapsed subjects
* Subjects with a history of myeloproliferative neoplasms (MPN);
* Subjects with a history of chronic myeloid leukemia (CML);
* Subjects with mixed phenotype acute leukemia (MPAL);
* Documented central nervous system leukemia;
* Hypersensitivity or allergy to any of the study drugs;
* Physical conditions or organ system dysfunction that impairs the ability to swallow capsules or tablets, or significantly affects gastrointestinal function and/or absorption (including malabsorption syndrome, small bowel resection, or uncontrolled inflammatory bowel disease);
* Cardiac conditions meeting any of the following:a) Long QT syndrome or QTc interval \> 480 ms;b) Second- or third-degree atrioventricular block; severe, uncontrolled arrhythmia requiring medical treatment;c) History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia, or any other treatable arrhythmia, clinically significant pericardial disease within 6 months prior to enrollment; or electrocardiographic evidence of acute ischemia or active conduction system abnormalities;
* Current concurrent malignancy other than adequately controlled non-melanoma skin basal cell carcinoma, in situ breast/cervical carcinoma, or other malignancies adequately controlled without treatment for more than 6 months;
* Significantly abnormal liver or renal function (serum bilirubin, AST, ALT, or serum creatinine \> 3 × upper limit of normal; excluding those deemed by the investigator to be related to AML);
* Subjects who have received previous anti-AML therapies other than hydroxyurea for cytoreduction, including but not limited to BCL-2, FLT3, IDH1 inhibitors, or other investigational agents;
* Coagulopathy unrelated to AML;
* HIV infection, syphilis infection, HCV infection, or active HBV infection (HBsAg positive; or HBsAg negative / HBcAb positive with HBV DNA \> 1.0 × ULN); Patients with previously documented such infections who have achieved undetectable viral load or sustained viral load reduction after treatment may be enrolled at the investigator's discretion;
* Other uncontrolled active infection (as judged by the investigator);
* Pregnant or breastfeeding women;
* Unable to understand or comply with the study protocol;
* Participation in other relevant clinical studies within 30 days (excluding diagnostic studies);
* Subjects deemed inappropriate for study participation by the investigator.

Where it's running

• Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Yang Shen
• Email: sy_clinicaltrial@163.com
• Phone: +86-021-64370045

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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.