A Phase 2 interventional study of Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib in Relapsed and Refractory Acute Myeloid Leukemia (RR-AML), sponsored by The Affiliated People's Hospital of Ningbo University. Not yet recruiting. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by The Affiliated People's Hospital of Ningbo University · Phase 2, Interventional, and Treatment
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.
4,347 studies on the registry are indexed under Recurrence; 1,004 are open to participants now.
This study's planned enrollment of 20 is below the median of 50 across 3,429 interventional studies indexed under Recurrence.
Browse Recurrence studies →The Affiliated People's Hospital of Ningbo University is the lead sponsor of 10 studies on the registry; 10 are open to participants now.
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Age ≥16 and \<65 years old.
Exclusion Criteria:
Acute promyelocytic leukemia (APL).
Drug: 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.
Overall Response Rate (ORR)
Time frame: At the end of Cycle 1 (each cycle is 28 days)
Complete Remission (CR) Rate
Time frame: At the end of Cycle 1 (each cycle is 28 days), with follow-up up to 6 months.
Safety: Incidence of Adverse Events
Time frame: From first dose up to 30-days after last study drug administration
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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The Affiliated People's Hospital of Ningbo University