Mitoxantrone Hydrochloride Liposome Combined With Cladribine And Sotorasib For Relapsed Refractory Acute Myeloid Leukemia

StatusNot Yet Recruiting
PhasePhase 2
Started

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Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07874737
Lead Sponsor The Affiliated People's Hospital of Ningbo University
Conditions
(from sponsor)		 Relapsed and Refractory Acute Myeloid Leukemia (RR-AML)
Related terms Leukemia, Myeloid, Acute, Recurrence
Enrollment 20 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov