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NCT07874737Not yet recruitingPhase 2

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

A Clinical Study Of Mitoxantrone Hydrochloride Liposome Plus Cladribine Combined With Sotorasib In Patients With Relapsed And Refractory Acute Myeloid Leukemia

Source: ClinicalTrials.gov · Last updated 15 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
20 (estimated)
First submitted
1 Oct 2026
Start date
Dec 2026
Primary completion date
Dec 2028
Lead sponsor
The Affiliated People's Hospital of Ningbo University
NCT number
NCT07874737

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 20
  • From Dec 2026 to the primary completion date, Dec 2028
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Acute promyelocytic leukemia (APL).
    • Prior allogeneic hematopoietic stem cell transplant within 100 days before enrollment.
    • Active uncontrolled severe infection.
    • Clinically significant cardiovascular disease including uncontrolled arrhythmia, myocardial infarction within 6 months.
    • Known central nervous system leukemia.
    • Pregnant or breastfeeding women.
    • Any severe medical or psychiatric condition that would interfere with study participation.

Who the study is looking for

  • Age ≥16 and \<65 years old.
    • Confirmed diagnosis of acute myeloid leukemia (AML) according to WHO classification.
    • Relapsed or refractory AML after at least one prior line of anti-leukemia therapy.
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
    • Adequate organ function: total bilirubin ≤1.5 × upper limit of normal (ULN); alanine transaminase (ALT) and aspartate transaminase (AST) ≤2.5 × ULN; estimated creatinine clearance ≥50 mL/min.
    • Women of child-bearing potential must have negative pregnancy test; all patients must agree to use effective contraception during study treatment and for 6 months after last dose.
    • Voluntarily sign written informed consent.

Age in the registry: 16 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.