Drug combinations for older adults with untreated acute myeloid leukemia
Tests drug combinations in older people with untreated acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Veneclax, Chidaniline Combined With Azacitidine Followed by Decitabine + MAG Regimen in the Treatment of Elderly Untreated 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 APL) who cannot have standard intensive chemotherapy.
- Age
- 60 years or older
- Sex
- Men and women can join.
- Disease stage
- Acute myeloid leukemia (non-M3), confirmed by tissue tests, not treated before; cannot have standard cytarabine and anthracycline induction because of age, other illness or patient preference. Expected survival over 3 months, ECOG 2 or lower.
- Earlier treatment
- No earlier treatment for AML. Earlier hypomethylating agents, venetoclax or chemotherapy for myelodysplastic syndrome (MDS) are not allowed.
- Biomarker or test result
- Estimated creatinine clearance of 30 mL/min or more; AST and ALT up to 3.0 x ULN; bilirubin up to 1.5 x ULN (unless caused by leukemia in the organ).
Main reasons for not taking part
- Acute promyelocytic leukemia (APL) or low-risk cytogenetics such as t(8;21), inv(16), t(16;16)
- Active leukemia in the central nervous system
- HIV-positive, or active HBV or HCV infection
- Active, uncontrolled severe infection
- Earlier solid organ transplant
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
- NCT06827899
- Record updated
- 20 February 2025
- Original description
A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)Read full original descriptionShow less
A Multicenter, Prospective, Single-arm Clinical Study of Veneclax, Chidaniline Combined With Azacitidine (VCA) Followed by Decitabine + MAG Regimen (D-MAG) in the Treatment of Elderly Untreated Acute Myeloid Leukemia (AML)
A multicenter, prospective, single-arm clinical study of veneclax, chidaniline combined with azacitidine (VCA) followed by decitabine + MAG regimen (D-MAG) in the treatment of elderly untreated acute myeloid leukemia (AML)
Inclusion: Histologically confirmed acute myeloid leukemia (non-M3). Have not received treatment before and cannot accept standard cytarabine and anthracycline induction regimen treatment due to age or comorbidity or patient preference; Age >= 60 years old, male or female, expected survival time greater than 3 months; Estimated creatinine clearance >= 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 <= 2; Able to understand and voluntarily provide informed consent.
Exclusion: Participants have received the following treatments: hypomethylation agents, venetoclax and/or chemotherapy for myelodysplastic syndrome (MDS), solid organ transplantation; A history of myeloproliferative neoplasms (MPN), including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myelogenous 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 tests); Suffering from chronic respiratory diseases requiring continuous oxygen inhalation, or having an obvious history of kidney, nervous system, psychiatric, endocrine, metabolic, immune, liver, and cardiovascular diseases; Suffering from malabsorption syndrome or other diseases that exclude the enteral route of administration; Active, uncontrolled severe infection; There is a history of other malignant tumors within 2 years, except for the following cases: adequately treated carcinoma in situ of the cervix or carcinoma in situ of the breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin; Mental disorders that will hinder research participation; Clinically significant QTc interval prolongation (male > 450 ms; female > 470 ms), ventricular tachycardia and atrial fibrillation, second-degree heart block, myocardial infarction, and congestive heart failure within one year before enrollment patients, and patients with coronary heart disease who have clinical symptoms and need drug treatment; White blood cell count > 25 x 10\^9/L (hydroxyurea or leukapheresis can meet this standard); 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 circumstances that the investigator believes that the patient is not suitable to participate in this trial.