Tests a two-step drug plan in older adults with newly diagnosed acute myeloid leukemia
Tests a two-step drug treatment in older adults with newly diagnosed acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Key facts
- Where
- Xiamen, ChinaSee the site
- Phase
- Phase 2
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 or older with newly diagnosed acute myeloid leukemia (not the M3 type) who cannot have standard intensive chemotherapy.
- Age
- 60 years or older
- Sex
- Men and women
- Disease stage
- Newly diagnosed acute myeloid leukemia (non-M3), confirmed by tissue tests. Not treated before. Cannot have standard cytarabine and anthracycline induction because of age, other illnesses or personal choice.
- Earlier treatment
- No earlier treatment for this leukemia. Cannot have had hypomethylating agents, venetoclax, or chemotherapy for myelodysplastic syndrome.
Main reasons for not taking part
- Acute promyelocytic leukemia or low risk genetic changes such as t(8;21), inv(16) or t(16;16)
- Active leukemia in the central nervous system
- HIV positive, or active hepatitis B or hepatitis C infection
- Earlier solid organ transplant
- White blood cell count above 25 × 10^9/L
Read by machine on 12 November 2026.
Where in China
- Bing XuXiamen, ChinaContact: Bing XuTaking 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
- NCT05603884
- Record updated
- 19 February 2025
- Original description
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)Read full original descriptionShow less
Venetoclax Combining Chidamide and Azacitidine (VCA) Regimen Followed by Dicitabine Combined With Liposome Mitoxantrone, Cytarabine, and G-CSF (D-MAG) Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML) : A Multicenter, Prospective, Single Arm Clinical Trial
The purpose of this study is to evaluate the safety and efficacy of Venetoclax Combining Chidamide and Azacitidine (VCA) Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Inclusion: 1) Histologically confirmed acute myeloid leukemia (non-M3). Treatment-na?ve and unable to receive standard cytarabine and anthracycline induction regimens due to age or comorbidities or patient preference; Age ≥ 60 years old, male or female, with an expected survival more than 3 months; Estimated creatinine clearance ≥ 30 mL/min. 4) AST and ALT ≤ 3.0 x ULN (unless leukemic organ involvement). Bilirubin ≤ 1.5 x ULN (unless considered due to leukemic organ involvement); ECOG ≤ 2. 6) Able to understand and voluntarily provide informed consent.
Exclusion: 1)Acute promyelocytic leukemia (APL) and low risk cytogenetics such as t(8;21), inv(16) or t(16;16); Active central nervous system leukemia. 3) History of myeloproliferative neoplasm (MPN) including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation and AML with BCR- ABL1 translocation; HIV positive patients and/or HBV or HCV active infection (documented by HBV-DNA and HCV-RNA positive test) 5) Patients suffering from chronic respiratory diseases that require continuous oxygen inhalation, or a history of obvious renal, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases 6) Patients suffering from malabsorption syndrome or other conditions that exclude enteral route of administration; Patients has clinically significant QTc prolongation (>450 ms in men; >470 ms in women), ventricular tachycardia and atrial fibrillation, second-degree heart block, myocardial infarction within the year prior to enrollment, and congestive heart failure;and patients with coronary heart disease with clinical symptoms requiring drug treatment; Active, uncontrolled severe infection. 9) History of other malignancies within 2 years, except for the following: Adequately treated cervix or breast cancer in situ; Basal cell cancer or local squamous cell carcinoma of the skin; 10) White blood cell count > 25 × 10\^9/L. (Hydroxyurea or leukapheresis may meet this criterion.) 11) Mental disorders that hinder research participation 12) Participants have received the following treatments: hypomethylating agents, veneclax and/or chemotherapy for myelodysplastic syndrome (MDS), solid organ transplantation; Any other circumstances that the investigator believes that the patient is not suitable to participate in this trial.