Actively Recruiting
Dose-escalation Study of D-CMG Regimen for the Treatment of Elderly Newly Diagnosed AML Patients
Led by The First Affiliated Hospital of Xiamen University · Updated on 2025-02-24
18
Participants Needed
1
Research Sites
132 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Dose-escalation Study of D-CMG Regimen for the Treatment of Elderly Newly Diagnosed AML Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed acute myeloid leukemia (non-M3) not previously treated and not suitable for standard induction therapy due to age, comorbidities, or preference
- Age between 60 and 75 years
- Expected survival time longer than 3 months
- Estimated creatinine clearance rate of at least 30 mL/min
- AST and ALT levels less than or equal to 3 times the upper normal limit (unless due to leukemia involvement)
- Bilirubin less than or equal to 1.5 times the upper normal limit (unless due to leukemia involvement)
- 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 such as t(8;21), inv(16), or t(16;16)
- Active central nervous system leukemia
- History of myeloproliferative neoplasms including myelofibrosis, primary thrombocythemia, polycythemia vera, chronic myeloid leukemia with or without BCR-ABL1 translocation, or AML with BCR-ABL1 translocation
- HIV-positive or active hepatitis B or C infection
- Clinically significant heart problems including prolonged QTc, ventricular tachycardia, atrial fibrillation, second-degree heart block, recent myocardial infarction, congestive heart failure, or coronary artery disease requiring medication
- Active, uncontrolled severe infection
- History of other cancers within the past 2 years except certain treated skin or in situ carcinomas
- White blood cell count greater than 25 x 10^9/L (treatable with hydroxyurea or leukapheresis)
- Mental impairment affecting study participation
- Any other condition the investigator considers unsuitable for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China, 361000
Actively Recruiting
Research Team
B
Bing Xu
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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