Relapsed and Refractory Acute Myeloid Leukemia (RR-AML)Phase 2NCT07874737
Mitoxantrone Hydrochloride Liposome Combined With Cladribine And Sotorasib For Relapsed Refractory Acute Myeloid Leukemia
A Phase 2 study testing Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib in people with Relapsed and Refractory Acute Myeloid Leukemia (RR-AML), run by The Affiliated People's Hospital of Ningbo University.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Relapsed and Refractory Acute Myeloid Leukemia (RR-AML)
- What is being tested?
- Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to May 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study Of Mitoxantrone Hydrochloride Liposome Plus Cladribine Combined With Sotorasib In Patients With Relapsed And Refractory Acute Myeloid Leukemia
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.
- Being tested
- Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib
- Medical subject headings
- Recurrence, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclibDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome-cladribine-sotoraclib Combination Therapy Arm | Experimental | Not described Receives: Drug: Mitoxantrone Hydrochloride Liposome+cladribine+sotoraclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate (ORR)
Measured: At the end of Cycle 1 (each cycle is 28 days)
Secondary outcomes (2)
Complete Remission (CR) Rate
Measured: At the end of Cycle 1 (each cycle is 28 days), with follow-up up to 6 months.
Safety: Incidence of Adverse Events
Measured: From first dose up to 30-days after last study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and Refractory Acute Myeloid Leukemia (RR-AML)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated People's Hospital of Ningbo University
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874737
- Sponsor's protocol ID
- 2026-R/R-AML
- Status last verified
- Oct 2026
- First submitted
- 1 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No