Tests a dose of liposomal mitoxantrone with decitabine and cytarabine for acute myeloid leukemia
Tests a drug combination in older adults with newly diagnosed acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Dose-escalation Study of D-CMG Regimen for the Treatment of Elderly Newly Diagnosed AML Patients
Key facts
- Where
- Xiamen, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 60-75 with newly diagnosed acute myeloid leukemia (not M3) who cannot have standard cytarabine and anthracycline induction treatment.
- Age
- 60-75 years
- Sex
- Men and women
- Disease stage
- Acute myeloid leukemia (non-M3), confirmed by tissue tests, not treated before. Cannot receive standard cytarabine and anthracycline induction because of age, other illnesses, or patient preference.
- Earlier treatment
- No earlier treatment for the leukemia.
Main reasons for not taking part
- Acute promyelocytic leukemia, or low-risk cytogenetics such as t(8;21), inv(16), or t(16;16)
- Active leukemia in the central nervous system
- History of myeloproliferative neoplasms, or AML with BCR-ABL1 translocation
- HIV-positive, or active HBV or HCV infection
- Active, uncontrolled severe infection
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 60 and 75 years old?
Source: NCT06651866, who can take part
Where in China
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaContact: Bing Xu, phDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The First Affiliated Hospital of Xiamen University
- Trial code
- NCT06651866
- Record updated
- 24 February 2025
- Original description
to observe the dose-limiting toxicity (DLT) of liposomal mitoxantrone hydrochloride injection combined with cytarabine and decitabine in the initial treatment of acute myeloid leukemia (AML), to explore the maximum tolerated dose (MTD) of the combined D-CMG regimen, and to evaluate its safety and efficacyRead full original descriptionShow less
Dose Escalation Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Decitabine and Cytarabine (D-CMG) for the Treatment of Elderly Newly Diagnosed Acute Myeloid Leukemia (AML) Patients
to observe the dose-limiting toxicity (DLT) of liposomal mitoxantrone hydrochloride injection combined with cytarabine and decitabine in the initial treatment of acute myeloid leukemia (AML), to explore the maximum tolerated dose (MTD) of the combined D-CMG regimen, and to evaluate its safety and efficacy
Inclusion: Histologically confirmed acute myeloid leukemia (non-M3) that has not been previously treated and cannot receive standard cytarabine and anthracycline induction therapy due to age, comorbidities, or patient preference; Aged 60-75 years, both male and female, with an expected survival time of more than 3 months; Estimated creatinine clearance rate ≥ 30 mL/min; AST and ALT ≤ 3.0 x ULN (unless considered due to leukemic organ involvement). Bilirubin ≤ 1.5 x ULN (unless considered due to leukemic organ involvement); ECOG Performance Status ≤ 2; Able to understand and voluntarily provide informed consent.
Exclusion: History of myeloproliferative neoplasms (MPN), including myelofibrosis, primary thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and AML with BCR-ABL1 translocation; HIV-positive patients and/or active HBV or HCV infection (as documented by positive HBV-DNA and HCV-RNA tests); Active, uncontrolled severe infection; History of other malignancies within the past 2 years, except for adequately treated in situ carcinoma of the cervix or breast; skin basal cell carcinoma or localized squamous cell carcinoma of the skin; Mental impairment that would compromise the ability to participate in the study; Clinically significant QTc prolongation (men > 450 ms; women > 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block, history of myocardial infarction within the past year, congestive heart failure, and coronary artery disease requiring medication; White blood cell count > 25 x 10\^9/L. (This criterion can be met with hydroxyurea or leukapheresis.); Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16); Active central nervous system leukemia; Any other situation in which the investigator believes that it would not be in the best interest of the patient to participate in the trial.