Prospective Observation of the indUction Regimen for Acute Non-Promyelocytic Myeloid Leukemia in Elderly; Decitabine for Chemotherapy Unfit Korean Acute Myeloid Leukemia (AML) Patients in Real Practice
试验速览
- 阶段
- 不适用
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- The rate of complete remission
研究概览
简要总结
Prospective multicenter, open-lab el, observational, single arm study of decitabine. Subjects will be elderly patients with newly diagnosed, treatment-naïve AML who are unfit to receive and not candidate for intensive induction chemotherapy (iIC)
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed and therapy-naïve AML (bone marrow or peripheral blood blast counts ≥20%)
- •65 years of age or older
- •Taking informed consent with signature and date
- •Not eligible for iIC based on either:
- •i) ≥75 years of age ii) comorbidity iii) secondary AML iv) poor performance (ECOG ≥2) v) Poor-risk by NCCN Guideline version 1.2015 vi) subject's choice (refusal for iIC) investigator's judgement incompatible with iIC
排除标准
- •Candidate for iIC at the time of enrollment
- •Promyelocytic leukemia, or AML with t(15;17) or PML/RARα rearrangement
- •AML with t(9;22) or BCR/ABL rearrangement
- •Leukemia central nervous system involvement
- •Extramedullary myeloid sarcoma without bone marrow involvement
- •Prior treatment with decitabine or azacitidine of any cause
- •Any leukemia-specific therapy, except for hydroxyurea for reducing leukemic cells prior decitabine
- •Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy, or curatively resected non-melanoma skin cancer or intraepithelial cancer
- •Premenopausal woman
- •Severe active infection
- •Uncontrolled bleeding Hypersensitivity to decitabine
研究组 & 干预措施
Decitabine
Decitabine 20mg/m2 will be given IV daily on Days 1-5 in 28-day cycles. Treatment should be given for at least 4 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy.
Beyond 4 cycles, treatment should continue as long as the subject continues to benefit based on investigator's judgment of no definitive progression.
干预措施: Decitabine (Drug)
结局指标
主要结局
The rate of complete remission
时间窗: after 4 cycles of decitabine treatment (about 4 months)
The rate of complete remission and complete remission with incomplete platelet recovery (CRp) will be measured by 4 cycles of decitabine treatment.
次要结局
- Clinical benefit rate(after 4 cycles of decitabine treatment (about 4 months))
- The rate of composite CR(after 4 cycles of decitabine treatment (about 4 months))
- Change of quality of life scale using EORTC QLQ-C30(after 4 cycles of decitabine treatment (about 4 months))
- Change of quality of life scale using EQ-5D-3L(after 4 cycles of decitabine treatment (about 4 months))
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03(until 4 cycles of decitabine treatment (about 4 months))
研究者
Hawk Kim
Professor
Ulsan University Hospital