Study of SA+X in the Treatment of Newly Diagnosed AML

June 2, 2026 updated by: Shen yang, Ruijin Hospital

Clinical Study of Sonrotoclax Combined With Azacitidine Plus Individualized Targeted Drugs in the Treatment of Newly Diagnosed Adult Acute Myeloid Leukemia

This is a phase II, open-label, multi-center study evaluating the efficacy and safety of sonrotoclax (SA) in combination with azacitidine (AZA) plus individualized targeted or chemotherapeutic agents in adult participants with newly diagnosed acute myeloid leukemia (AML). Eligible participants will be stratified into different treatment arms based on genetic background (FLT3/IDH1 mutation status) and fitness for intensive chemotherapy. All participants will receive sonrotoclax with dose escalation from 20 mg/day to 320 mg/day, followed by maintenance dosing, which may be temporarily held by the investigator from Day 14 to Day 28 of each 28-day cycle based on the participant's condition, combined with azacitidine 75 mg/m²/day intravenously on Days 1-7. For participants fit for intensive chemotherapy, additional anthracycline (daunorubicin 60 mg/m²/day or idarubicin 10 mg/m²/day on Days 1-3) will be administered. For participants with FLT3 mutations, gilteritinib 80 mg once daily on Days 1-14 will be added; for those with IDH1 mutations, ivosidenib 500 mg once daily on Days 1-28 will be added.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
205

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 myelodysplastic syndromes (MDS);
  • Subjects with a history of chronic myeloid leukemia (CML);
  • Subjects with mixed phenotype acute leukemia (MPAL);
  • Documented central nervous system leukemia; or documented extramedullary leukemia (e.g., myeloid sarcoma, skin infiltration), excluding liver, spleen, and lymph node involvement;
  • 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;
  • Previous or 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);
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SA+Anthracycline
Drug: Sonrotoclax
For all the participants who are eligible for this trial, Sonrotoclax (SON): 20 mg/day on Day 1, 40 mg/day on Day 2, 80 mg/day on Day 3, 160 mg/day on Day 4, and 320 mg/day on Days 5-28 of a 28-day cycle; the administration of SON may be temporarily held by the investigator from Day 14 to Day 28 based on the participant's condition.
Drug: Azacitidine (AZA)
For all the participants who are eligible for this trial, Azacitidine (AZA): 75 mg/m² per day on Days 1-7.
Drug: Anthracycline
For FLT3/IDH1 wild-type participants who are eligible for chemotherapy, Anthracycline: Daunorubicin (DNR) 45 mg/m² per day on Days 1-3, or Idarubicin (IDA) 6 mg/m² per day on Days 1-3.
Experimental: SA+FLT3 inhibitor
Drug: Sonrotoclax
For all the participants who are eligible for this trial, Sonrotoclax (SON): 20 mg/day on Day 1, 40 mg/day on Day 2, 80 mg/day on Day 3, 160 mg/day on Day 4, and 320 mg/day on Days 5-28 of a 28-day cycle; the administration of SON may be temporarily held by the investigator from Day 14 to Day 28 based on the participant's condition.
Drug: Azacitidine (AZA)
For all the participants who are eligible for this trial, Azacitidine (AZA): 75 mg/m² per day on Days 1-7.
Drug: Gilteritinib
For FLT3 mutant participants, FLT3 inhibitor (FLT3i): Gilteritinib 80 mg once daily on Days 1-14.
Experimental: SA+IDH1 inhibitor
Drug: Sonrotoclax
For all the participants who are eligible for this trial, Sonrotoclax (SON): 20 mg/day on Day 1, 40 mg/day on Day 2, 80 mg/day on Day 3, 160 mg/day on Day 4, and 320 mg/day on Days 5-28 of a 28-day cycle; the administration of SON may be temporarily held by the investigator from Day 14 to Day 28 based on the participant's condition.
Drug: Azacitidine (AZA)
For all the participants who are eligible for this trial, Azacitidine (AZA): 75 mg/m² per day on Days 1-7.
Drug: Ivosidenib
For IDH1 mutant participants, IDH1 inhibitor (IDH1i): Ivosidenib 500 mg once daily on Days 1-28.
Experimental: SA
Drug: Sonrotoclax
For all the participants who are eligible for this trial, Sonrotoclax (SON): 20 mg/day on Day 1, 40 mg/day on Day 2, 80 mg/day on Day 3, 160 mg/day on Day 4, and 320 mg/day on Days 5-28 of a 28-day cycle; the administration of SON may be temporarily held by the investigator from Day 14 to Day 28 based on the participant's condition.
Drug: Azacitidine (AZA)
For all the participants who are eligible for this trial, Azacitidine (AZA): 75 mg/m² per day on Days 1-7.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Composite Complete Remission
Time Frame: At the end of 2 cycles of induction therapy with the SA+X regimen (each cycle is 28 days); at the end of 4 cycles of induction therapy with the SA regimen (each cycle is 28 days).
At the end of 2 cycles of induction therapy with the SA+X regimen (each cycle is 28 days); at the end of 4 cycles of induction therapy with the SA regimen (each cycle is 28 days).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Minimal Residual Disease (MRD) Negativity Rate
Time Frame: At the end of 2 cycles of induction therapy with the SA+X regimen (each cycle is 28 days); at the end of 4 cycles of induction therapy with the SA regimen (each cycle is 28 days).
At the end of 2 cycles of induction therapy with the SA+X regimen (each cycle is 28 days); at the end of 4 cycles of induction therapy with the SA regimen (each cycle is 28 days).
Overall Response Rate
Time Frame: At the end of 2 cycles of induction therapy with the SA+X regimen (each cycle is 28 days); at the end of 4 cycles of induction therapy with the SA regimen (each cycle is 28 days).
At the end of 2 cycles of induction therapy with the SA+X regimen (each cycle is 28 days); at the end of 4 cycles of induction therapy with the SA regimen (each cycle is 28 days).
Overall Survival
Time Frame: Time from enrollment to all-cause death within 3 years
Time from enrollment to all-cause death within 3 years
Event-free Survival
Time Frame: Time from enrollment to treatment failure, relapse, or death from any cause within 3 years
Time from enrollment to treatment failure, relapse, or death from any cause within 3 years
Adverse Events
Time Frame: From the start of induction to 30 days after the completion of treatment
According to the CTCAE Version 6.0 criteria
From the start of induction to 30 days after the completion of treatment
Time to neutrophil and platelet recovery
Time Frame: From the start of induction to 30 days after the completion of treatment
From the start of induction to 30 days after the completion of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruijin Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 21, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SAXUM_2026

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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