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

NCT07874737 | Not Yet Recruiting Phase 2

• 1 other identifier: 2026-R/R-AML
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Relapsed and Refractory Acute Myeloid Leukemia (RR-AML)

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  At the end of Cycle 1 (each cycle is 28 days)

Secondary Outcomes (2)

• Complete Remission (CR) Rate

  At the end of Cycle 1 (each cycle is 28 days), with follow-up up to 6 months.

• Safety: Incidence of Adverse Events

  From first dose up to 30-days after last study drug administration

Study Arms (1)

Mitoxantrone Hydrochloride Liposome-cladribine-sotoraclib Combination Therapy Arm

EXPERIMENTAL

Drug: Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib

Interventions

Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib DRUG

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.

Mitoxantrone Hydrochloride Liposome-cladribine-sotoraclib Combination Therapy Arm

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated People's Hospital of Ningbo University: lead

MeSH Terms

Conditions

Recurrence; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Ying Lu

CONTACT

86+13486090834; rmluying@nbu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2026
• First Posted: October 15, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: October 15, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share