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Phase II Study of Sonrotoclax Combined With Chemotherapy in the Treatment of Newly Diagnosed Acute Myeloid Leukemia
Sponsor: Shanghai Jiao Tong University School of Medicine
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.
Official title: Risk-stratified Treatment of Sonrotoclax Combined With Chemotherapy in Patients With Newly Diagnosed Acute Myeloid Leukemia: a Multicenter, Phase II Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
47
Start Date
2024-09-04
Completion Date
2028-06-30
Last Updated
2024-07-11
Healthy Volunteers
No
Conditions
Interventions
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.
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
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).
Azacitidine
75 mg/m\^2, subcutaneously, once daily, on D1-7
allo-HSCT
Per standard of procedure
Locations (1)
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, China