AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 2NCT06497062

Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

A Phase 2 study testing sonrotoclax, idarubicin/daunorubicin and Cytarabine in people with Acute Myeloid Leukemia, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This single-armed study aims to investigate the safety and efficacy of sonrotoclax in combination with intensive chemotherapy in subjects with newly diagnosed AML. Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet (ELN) recommendations and MRD status to receive specific… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
sonrotoclax, idarubicin/daunorubicin and Cytarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteChina
Study dates
30 Oct 2024to 30 Jun 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Newly diagnosed untreated acute myeloid leukemia patients;
  • Age range from 18 to 75 years old;
  • The Eastern Cooperative oncology Group (ECOG) score is ≤ 2 points;
  • The following organ functional conditions must be met:
  • Liver function (bilirubin<2mg/dL, AST and/or ALT<3 x ULN)
  • Renal function (blood creatinine clearance rate ≥ 30 mL/min)
Show all 16Show fewer
  • Cardiac function (left ventricular ejection fraction ≥ 50%)
  • If the age is ≥ 60 years old, the following conditions must be further met;
  • Charlson comorbidity index (CCI) ≤ 1
  • Activity of Daily Living Scale (ADL)>100
  • No cognitive impairment, Mini Mental State Examination (MMSE) ≥ 28
  • No impairment of living ability, Short Physical Performance Battery Protocol (SPPB) ≥ 9
  • Women with fertility must have a negative serum pregnancy test ≤ 7 days before the first administration. In addition, they must use efficient contraceptive methods before the first dose of study medication, during the study treatment period, and for ≥ 180 days after the last dose of study medication.
  • Non infertile males must use efficient contraceptive methods during the study treatment period and within ≥ 90 days after the last dose of the study medication. During this period, they are not allowed to donate sperm.
  • The patient fully understands this study, obtains an informed consent form (ICF) signed by the patient or their legal representative, and follows the research protocol and follow-up process.
  • The expected lifespan is greater than 12 weeks.

Who cannot join

  • Acute promyelocytic leukemia (APL)；
  • Malignant tumor in the past 2 years, except for cured localized skin cancer, superficial bladder cancer, cervical cancer or cancer in situ of breast cancer, and localized prostate cancer with Gleason score ≤ 6;
  • Uncontrolled concurrent diseases, including but not limited to: ongoing or active uncontrolled infections, cardiovascular or mental illnesses/social situations that may limit compliance with research requirements;
  • It is known that the subjects are positive for hepatitis B or hepatitis C infection, except those whose viral load cannot be detected within 3 months (Note: patients with HBcAb+but HBsAg - can only meet the condition if hepatitis B virus (HBV) DNA cannot be detected in the detection with sensitivity ≤ 20 IU/mL. In this case, patients should receive regular monitoring of HBV DNA and receive prophylactic antiviral drug treatment according to the central diagnosis and treatment routine; Patients with HCV antibody+are eligible only if they cannot detect HCV RNA and are willing to monitor HCV reactivation；
  • Receive any moderate or strong CYP3A4 inhibitor (7 days or 5 half-lives, whichever is longer) or moderate or strong CYP3A4 inducer (14 days or 5 half-lives, whichever is longer) treatment before the first use of Sonrotoclax；
  • Patients who are known to have hypersensitivity reactions to any component in the study protocol;
Show all 10Show fewer
  • Known central nervous system involvement in AML;
  • Previously received organ, bone marrow, or peripheral blood organ transplantation；
  • Participate in another therapeutic clinical study simultaneously；
  • Pregnant or lactating women, or male and female patients planning to have children during the study period.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

Other trials in China

About this study

Official title: Risk-stratified Treatment of Sonrotoclax Combined With Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia: a Multicenter, Phase II Study

This single-armed study aims to investigate the safety and efficacy of sonrotoclax in combination with intensive chemotherapy in subjects with newly diagnosed AML. Subjects will be stratified based on the genetic risk classification of 2022 European LeukemiaNet (ELN) recommendations and MRD status to receive specific consolidation therapy after the induction therapy.

Read the detailed description

47 subjects who meet the eligibility criteria will receive no more than 2 cycles (each cycle is 28 days) of induction therapy with sonrotoclax on day5-14 combined with the standard 3+7 intensive chemotherapy regimen (3+7 regimen) containing cytarabine, and daunorubicin or idarubicin. In cycle(C)1 of induction therapy, sonrotoclax will be administered orally once daily by a 4-day dose rump-up of 20mg on Day(D)5, 40mg on D6, 80mg on D7, and 160mg on D8-14. The first 6 subjects will be enrolled in a Safety Run-in period in C1 to assess tolerability and determine the final sonrotoclax regimen. Within 42 days or before the next cycle of therapy, if ≤1 of 6 subjects has dose-limiting toxicities (DLT), the study will be continued with the sonrotoclax dose regimen as above, and if ≥2 of 6 subjects have DLTs, the dose will be adjusted. Adjustment may include reducing the dose, shortening the duration of each cycle, or terminating the study, based on the DLTs' characteristics.

Subjects who achieve a composite complete remission (CRc) after induction therapy will receive further consolidation therapy, which regimen will be decided based on the ELN risk at diagnosis and MRD status detected by MFC after induction therapy.

After consolidation, subjects will receive once daily sonrotoclax orally combined with azacitidine (AZA) subcutaneously once daily alternating with AZA monotherapy every 2 cycles as maintenance therapy until unacceptable toxicity, 12 months, recurrence, death, withdrawal of informed consent, or study termination determined by investigators.

This single-armed study aims to investigate the safety and efficacy of a risk-stratified regimen of sonrotoclax in combination with intensive chemotherapy in subjects with newly diagnosed AML.

Being tested
sonrotoclax, idarubicin/daunorubicin, Cytarabine, Azacitidine, allo-HSCT
Keywords
Sonrotoclax, Risk-stratified, Acute myeloid leukemia
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.

  • sonrotoclaxDrug

    Also called BGB11417

    Orally once daily, on D5-14. A 4-day dose ramp-up is required for the first induction. The dosing regimen will be determined in the Safety Run-in phase.

    If a second induction is needed, dose ramp-up is not required. In the consolidation therapy phase, subjects in the group with favorable risk and MRD negative do not need to receive Sonrotoclax treatment, and subjects in the group with favorable risk and MRD positive, or with intermediate and adverse risk will receive sonrotoclax on D1-7 at the target dose determined in the safety run-in phase, dose ramp-up is not required.

    In the maintenance therapy phase, subjects will receive once daily sonrotoclax on D1-14 at the target dose determined in the safety run-in phase.

  • idarubicin/daunorubicinDrug

    Also called IDA/DNR

    idarubicin: On D1-3, intravenously, 10 mg/m^2 for subjects aged <60 years, 6 mg/m^2 for subjects aged ≥60 years daunorubicin: On D1-3, intravenously, 60 mg/m^2 for subjects aged <60 years, 40 mg/m^2 for subjects aged ≥60 years

  • CytarabineDrug

    Also called Ara-c

    In induction therapy phase: intravenously, 100 mg/m^2 on D1-7. In consolidation therapy phase: subjects with favorable-risk and MRD negative will receive cytarabine intravenously at 2 g/m^2/q12h for those aged <60 years, at 1g/m^2/q12h for those ≥60 years on D1-3 or 3+7 regimen, and subjects with favorable-risk and MRD positive or intermediate or adverse-risk will receive cytarabine intravenously at 1 g/m^2/d q12h on D1-3(in combination with sonrotoclax).

  • AzacitidineDrug

    Also called AZA

    75 mg/m^2, subcutaneously, once daily, on D1-7

  • allo-HSCTProcedure or surgery

    Per standard of procedure

Study groups in NCT06497062
Study groupRoleWhat they receive
Assigned InterventionsExperimentalExperimental: Sonrotoclax combined with intensive chemotherapy. Subjects receive induction therapy consisting of sonrotoclax combined with a 3+7 regimen. According to the ELN risks and MRD status, subjects who achieve composite complete remission (CRc) proceed with consolidation therapy, and allogeneic hematopoietic stem-cell transplant (allo-HSCT) can be included per investigator's decision. After the consolidation, subjects will receive sonrotoclax combined with azacitidine (AZA) alternating with AZA monotherapy every 2 cycles as maintenance therapy until intolerable toxicity, 12 months, relapse, death, withdrawal of informed consent, or study termination determined by investigators, whichever occurs first.
Receives: Drug: sonrotoclax; Drug: idarubicin/daunorubicin; Drug: Cytarabine; Drug: Azacitidine; Procedure: allo-HSCT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. EFS

    event free survival rate

    Measured: 2-year

Secondary outcomes (6)

  1. Composite complete remission rate

    Complete remission/complete remission with partial hematological recovery/complete remission with incomplete hematological recovery

    Measured: Up to cycle 2 (each cycle is 28 days)

  2. The complete remission rate of MRD negative

    The complete remission rate of MRD negative

    Measured: Up to cycle 2 (each cycle is 28 days)

  3. RFS

    relapse free survival rate

    Measured: Only for subjects who have achieved CR, CRh, or CRi; The time from the first attainment of eligible remission (CR, CRh, or CRi) after the start of treatment to the recording of disease recurrence or death, whichever occurs first. Up to 24 months

  4. OS

    overall survival rate

    Measured: up to 24 months

  5. AE, SAE

    Adverse event，Serious adverse events

    Measured: up to 24 months

  6. Early mortality rate

    Mortality within 30 days after first study medication and within 60 days after first study medication

    Measured: Within 30 and 60 days after the first study medication

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2024
  2. Study start30 Oct 2024
  3. Primary completion31 Oct 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
47 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06497062
Sponsor's protocol ID
BGB-11417-2001-IIT
Status last verified
Apr 2026
First submitted
25 Jun 2024
Last updated
30 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang Y, Wu M, Jin Z, Yang L, Huang X, Li W, Zhu H, Wang W, Chen Q, Liu L, Chen Z, Wang S, Li J. Risk-stratified treatment of sonrotoclax with chemotherapy in newly diagnosed acute myeloid leukemia: a study protocol. Future Oncol. 2025 Apr;21(8):953-958. doi: 10.1080/14796694.2025.2469487. Epub 2025 Feb 26.

    PubMed 40008672

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing sonrotoclax, idarubicin/daunorubicin and Cytarabine in people with Acute Myeloid Leukemia, run by Shanghai Jiao Tong University School of Medicine 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 16 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 30 Apr 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EFS (time frame: 2-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06497062, which also lists 1 linked publication.

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 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in