Dose Escalation Study of Liposomal Mitoxantrone Hydrochloride Injection Combined With Decitabine and Cytarabine (D-CMG) for the Treatment of Elderly Newly Diagnosed Acute Myeloid Leukemia (AML) Patients
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Maximum tolerated dose (MTD)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed acute myeloid leukemia (non-M3) that has not been previously treated and cannot receive standard cytarabine and anthracycline induction therapy due to age, comorbidities, or patient preference.
- •Aged 60-75 years, both male and female, with an expected survival time of more than 3 months.
- •Estimated creatinine clearance rate ≥ 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 Performance Status ≤
- •Able to understand and voluntarily provide informed consent.
排除标准
- •Acute promyelocytic leukemia (APL) and low-risk cytogenetics, such as t(8;21), inv(16), or t(16;16).
- •Active central nervous system leukemia.
- •History of myeloproliferative neoplasms (MPN), including myelofibrosis, primary thrombocythemia, polycythemia vera, chronic myeloid leukemia (CML) with or without BCR-ABL1 translocation, and AML with BCR-ABL1 translocation.
- •HIV-positive patients and/or active HBV or HCV infection (as documented by positive HBV-DNA and HCV-RNA tests).
- •Clinically significant QTc prolongation (men > 450 ms; women > 470 ms), ventricular tachycardia, atrial fibrillation, second-degree heart block, history of myocardial infarction within the past year, congestive heart failure, and coronary artery disease requiring medication.
- •Active, uncontrolled severe infection.
- •History of other malignancies within the past 2 years, except for adequately treated in situ carcinoma of the cervix or breast; skin basal cell carcinoma or localized squamous cell carcinoma of the skin.
- •White blood cell count > 25 x 10^9/L. (This criterion can be met with hydroxyurea or leukapheresis.)
- •Mental impairment that would compromise the ability to participate in the study.
- •Any other situation in which the investigator believes that it would not be in the best interest of the patient to participate in the trial.
研究组 & 干预措施
D-CMG
Liposomal mitoxantrone hydrochloride injection (Doxorubicin®): Used after dilution with 250mL of 5% glucose injection (50mg/mL), with an intravenous drip time of at least 60 minutes.
- Level 1: 12mg/m2, IV drip, day 4;
- Level 2: 18mg/m2, IV drip, day 4; Decitabine: 25mg, IV drip, days 1-3; Cytarabine: 10mg/m2, every 12 hours, IV drip, days 4-10; G-CSF: 300 ug, IV drip, days 1-5; Each cycle is 4 weeks, with a total of 2 cycles, and DLT is observed in the first cycle.
Note: Patients who achieve CR (Complete Remission) and PR (Partial Remission) in the first cycle can continue with the original dose for one more cycle, and then the investigator decides whether to continue this regimen or choose another regimen for maintenance therapy; Patients with NR (No Remission) in the first cycle will be withdrawn from this study.
干预措施: D-CMG (Drug)
结局指标
主要结局
Maximum tolerated dose (MTD)
时间窗: Up to 24 months
Defined as the highest dose at which less than 2 out of 6 (ie. 33%) participants experience a Dose-Limiting Toxicity (DLT).
次要结局
- Complete Response Rate (CR)(Up to 24 months)
- Complete Response with incomplete blood count recovery (CRi)(Up to 24 months)
- Disease free survival (DFS)(Up to 24 months)
- Overall survival (OS)(Up to 24 months)
研究者
Bing, Xu
Principal Investigator
The First Affiliated Hospital of Xiamen University