Actively Recruiting
VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-19
66
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
T
The First Affiliated Hospital of Xiamen University
Lead Sponsor
C
Chipscreen Biosciences, Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
VCA Regimen Followed by D-MAG Regimen on the Treatment of Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia (AML)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed acute myeloid leukemia (non-M3), treatment-naive and unable to receive standard chemotherapy due to age, health, or preference
- Age 60 years or older, male or female, with expected survival over 3 months
- Estimated creatinine clearance of at least 30 mL/min
- Liver function tests (AST and ALT) less than or equal to 3 times the upper normal limit unless leukemia affects organs
- Bilirubin less than or equal to 1.5 times the upper normal limit unless due to leukemia involvement
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
- Able to understand and voluntarily provide informed consent
You will not qualify if you...
- Acute promyelocytic leukemia (APL) or low-risk cytogenetics like t(8;21), inv(16), or t(16;16)
- Active central nervous system leukemia
- History of myeloproliferative neoplasm including myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia with or without BCR-ABL1, and AML with BCR-ABL1
- Positive for HIV or active hepatitis B or C infection
- Chronic respiratory diseases requiring continuous oxygen or history of severe kidney, nervous system, psychiatric, endocrine, metabolic, immune, liver, or heart diseases
- Malabsorption syndrome or conditions preventing oral medication
- Significant heart problems including prolonged QTc, ventricular tachycardia, atrial fibrillation, second-degree heart block, recent heart attack within 1 year, congestive heart failure, or symptomatic coronary heart disease
- Active uncontrolled severe infection
- History of other cancers within 2 years except certain treated skin or breast cancers
- White blood cell count greater than 25 x 10^9/L unless controlled with medication
- Mental disorders preventing study participation
- Prior treatment with hypomethylating agents, Venetoclax, or chemotherapy for myelodysplastic syndrome
- Any other condition deemed unsuitable by the investigator
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, 361003
Actively Recruiting
Research Team
B
Bing Xu, M.D.
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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