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Mitoxantrone Hydrochloride Liposome Combined With Cladribine And Sotorasib For Relapsed Refractory Acute Myeloid Leukemia
Sponsor: The Affiliated People's Hospital of Ningbo University
Summary
This is a single-arm, single-center clinical study to assess the efficacy and safety of Mitoxantrone Hydrochloride Liposome combined with cladribine and sotoraclib in patients with relapsed/refractory acute myeloid leukemia (R/R-AML). Eligible adult participants will receive the following regimen: Mitoxantrone Hydrochloride Liposome 20 mg/m²; cladribine 5 mg/m² on day 1-5; sotoraclib 20 mg on day1, 40 mg on day2, 80 mg on day3, 160 mg on day4-day9. Clinical efficacy endpoints include overall response rate. Safety will be assessed via adverse event monitoring and laboratory examinations. All subjects will be followed up for survival and relapse status.
Official title: A Clinical Study Of Mitoxantrone Hydrochloride Liposome Plus Cladribine Combined With Sotorasib In Patients With Relapsed And Refractory Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
16 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2026-12
Completion Date
2029-05
Last Updated
2026-10-15
Healthy Volunteers
No
Interventions
Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib
Mitoxantrone Hydrochloride Liposome 20 mg/m² intravenous infusion on Day 1; cladribine 5 mg/m² intravenous infusion on Day 1-Day 5; sotoraclib 20 mg Day1, 40 mg Day2, 80 mg Day3, 160 mg Day4-Day9 intravenous infusion, administered as one treatment cycle.