Acute Myeloid LeukemiaPhase 2NCT07548710
Study of SA+X in the Treatment of Newly Diagnosed AML
A Phase 2 study testing Anthracycline, Ivosidenib and Gilteritinib in people with Acute Myeloid Leukemia, run by Ruijin Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Anthracycline, Ivosidenib and Gilteritinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 21 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai
Shanghai, Shanghai Municipality, 200025
Yang Shen, +86-021-64370045, cxj0524@163.com
About this study
Official title: 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.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Anthracycline, Ivosidenib, Gilteritinib, Sonrotoclax, Azacitidine (AZA)
- Keywords
- Newly Diagnosed Adult Acute Myeloid Leukemia, Sonrotoclax, Azacitidine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthracyclineDrug
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.
IvosidenibDrug
For IDH1 mutant participants, IDH1 inhibitor (IDH1i): Ivosidenib 500 mg once daily on Days 1-28.
GilteritinibDrug
For FLT3 mutant participants, FLT3 inhibitor (FLT3i): Gilteritinib 80 mg once daily on Days 1-14.
SonrotoclaxDrug
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.
Azacitidine (AZA)Drug
For all the participants who are eligible for this trial, Azacitidine (AZA): 75 mg/m² per day on Days 1-7.
Quizartinib DihydrochlorideDrug
For FLT3-ITD mutant participants, FLT3 inhibitor (FLT3i): Quizartinib Dihydrochloride 40 mg once daily on Days 1-14.
| Study group | Role | What they receive |
|---|---|---|
| SA+Anthracycline | Experimental | Not described Receives: Drug: Anthracycline; Drug: Sonrotoclax; Drug: Azacitidine (AZA) |
| SA+FLT3 inhibitor | Experimental | For patients harboring FLT3-TKD mutations, gilteritinib is the preferred agent; for those with FLT3-ITD mutations, either gilteritinib or quizartinib is a valid treatment option. Receives: Drug: Gilteritinib; Drug: Sonrotoclax; Drug: Azacitidine (AZA); Drug: Quizartinib Dihydrochloride |
| SA+IDH1 inhibitor | Experimental | Not described Receives: Drug: Ivosidenib; Drug: Sonrotoclax; Drug: Azacitidine (AZA) |
| SA | Experimental | Not described Receives: Drug: Sonrotoclax; Drug: Azacitidine (AZA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Complete Remission
Measured: 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 outcomes (6)
Minimal Residual Disease (MRD) Negativity Rate
Measured: 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
Measured: 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
Measured: Time from enrollment to all-cause death within 3 years
Event-free Survival
Measured: Time from enrollment to treatment failure, relapse, or death from any cause within 3 years
Adverse Events
According to the CTCAE Version 6.0 criteria
Measured: From the start of induction to 30 days after the completion of treatment
Time to neutrophil and platelet recovery
Measured: From the start of induction to 30 days after the completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start1 May 2026
- Primary completion31 May 2027 (estimated)
- Study completion21 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 205 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Fengxian District Central Hospital, Chinese People's Liberation Army No 455 Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Tong Ren Hospital, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, Shanghai Jiahui International Hospital, The First Hospital of Jilin University, Huadong Hospital, The First People's Hospital of Yunnan, Shanghai 7th People's Hospital
- Responsible party
- Principal investigator, Shen yang, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07548710
- Sponsor's protocol ID
- SAXUM_2026
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Sonrotoclax Combined With Azacitidine Plus Individualized Targeted Drugs in the Treatment of Newly Diagnosed Adult Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07548710
- Acronym / sponsor ID
- SAXUM_2026
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Newly Diagnosed Adult Acute Myeloid Leukemia, Sonrotoclax, Azacitidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 205 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Fengxian District Central Hospital, Chinese People's Liberation Army No 455 Hospital, Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai Tong Ren Hospital, Zhaxin Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai, Shanghai Jiahui International Hospital, The First Hospital of Jilin University, Huadong Hospital, The First People's Hospital of Yunnan, Shanghai 7th People's Hospital
- Study start
- 1 May 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 21 Dec 2028 (estimated)
- First posted
- 23 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SA+Anthracycline | Experimental | Drug: Anthracycline, Drug: Sonrotoclax, Drug: Azacitidine (AZA) |
| SA+FLT3 inhibitor | Experimental | Drug: Gilteritinib, Drug: Sonrotoclax, Drug: Azacitidine (AZA), Drug: Quizartinib DihydrochlorideFor patients harboring FLT3-TKD mutations, gilteritinib is the preferred agent; for those with FLT3-ITD mutations, either gilteritinib or quizartinib is a valid treatment option. |
| SA+IDH1 inhibitor | Experimental | Drug: Ivosidenib, Drug: Sonrotoclax, Drug: Azacitidine (AZA) |
| SA | Experimental | Drug: Sonrotoclax, Drug: Azacitidine (AZA) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (19 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnthracyclineFor 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. | Drug | SA+Anthracycline |
| IvosidenibFor IDH1 mutant participants, IDH1 inhibitor (IDH1i): Ivosidenib 500 mg once daily on Days 1-28. | Drug | SA+IDH1 inhibitor |
| GilteritinibFor FLT3 mutant participants, FLT3 inhibitor (FLT3i): Gilteritinib 80 mg once daily on Days 1-14. | Drug | SA+FLT3 inhibitor |
| SonrotoclaxFor 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 | SA, SA+Anthracycline, SA+FLT3 inhibitor, SA+IDH1 inhibitor |
| Azacitidine (AZA)For all the participants who are eligible for this trial, Azacitidine (AZA): 75 mg/m² per day on Days 1-7. | Drug | SA, SA+Anthracycline, SA+FLT3 inhibitor, SA+IDH1 inhibitor |
| Quizartinib DihydrochlorideFor FLT3-ITD mutant participants, FLT3 inhibitor (FLT3i): Quizartinib Dihydrochloride 40 mg once daily on Days 1-14. | Drug | SA+FLT3 inhibitor |
Primary outcome
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).
6 secondary outcomes
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).
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).
Overall Survival
Time frame: 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
Adverse Events
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anthracycline, Ivosidenib and Gilteritinib in people with Acute Myeloid Leukemia, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Shen (+86-021-64370045, sy_clinicaltrial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.