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

NCT06497062 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-04-30

No results posted yet for this study

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 consolidation therapy after the induction therapy.

Conditions

Interventions

DRUG

sonrotoclax

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.

DRUG

idarubicin/daunorubicin

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

DRUG

Cytarabine

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).

DRUG

Azacitidine

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

PROCEDURE

allo-HSCT

Per standard of procedure

Sponsors & Collaborators

  • Ruijin Hospital

    collaborator OTHER

  • BeiGene

    collaborator INDUSTRY

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Junmin Li · Ruijin Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-30
Primary Completion
2027-10-31
Completion
2028-06-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06497062 on ClinicalTrials.gov