Actively Recruiting
Veneclax, Chidaniline Combined With Azacitidine Followed by Decitabine + MAG Regimen in the Treatment of Elderly Untreated AML
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-20
66
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Xiamen University
Lead Sponsor
F
Fujian Provincial Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Veneclax, Chidaniline Combined With Azacitidine Followed by Decitabine + MAG Regimen in the Treatment of Elderly Untreated AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed acute myeloid leukemia (non-M3) with no prior treatment and unable or unwilling to receive standard cytarabine and anthracycline induction therapy due to age, comorbidity, or preference
- Age 60 years or older, male or female, with expected survival time over 3 months
- Estimated creatinine clearance of at least 30 mL/min
- AST and ALT levels less than or equal to 3 times the upper limit of normal unless due to leukemic organ involvement
- Bilirubin less than or equal to 1.5 times the upper limit of normal unless due to leukemic organ involvement
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower
- Ability to understand and voluntarily provide informed consent
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia (APL) or low-risk cytogenetics such as t(8;21), inv(16), or t(16;16)
- Active central nervous system leukemia
- History of myeloproliferative neoplasms, including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myelogenous leukemia with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation
- Positive for HIV or with active hepatitis B or C infection
- Chronic respiratory disease requiring continuous oxygen or significant history of kidney, nervous system, psychiatric, endocrine, metabolic, immune, liver, or cardiovascular diseases
- Malabsorption syndrome or other conditions preventing oral medication use
- Significant heart conditions including QTc prolongation, ventricular tachycardia, atrial fibrillation, second-degree heart block, recent myocardial infarction, congestive heart failure, or symptomatic coronary heart disease needing treatment
- Active, severe infections not controlled
- History of other cancers within the last 2 years except treated carcinoma in situ of cervix or breast, basal cell carcinoma, or localized squamous cell carcinoma of the skin
- White blood cell count above 25 x 10^9/L unless controlled by hydroxyurea or leukapheresis
- Mental disorders preventing study participation
- Prior treatment with hypomethylation agents, venetoclax, chemotherapy for myelodysplastic syndrome, or solid organ transplantation
- Any other conditions deemed unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Bing Xu
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
B
Bing Xu
CONTACT
Z
Zhifeng Li
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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