KCT0004569尚未招募未知
Single agent azacitidine for pre-treated acute myeloid leukemia patients not expecting help of further intensive re-induction chemotherapy: a phase II trial
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 23
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) patients aged 19 years or older
- •(2) Those who have been confirmed as acute myeloid leukemia according to the World Health Organization diagnostic criteria.
- •(3) Newly diagnosed as acute myeloid leukemia and received at least 1 intensive remission induction chemotherapy or a patients who obtained complete remission previously; however, the patient at least one-line of re-treatment due to relapse of disease
- •-Intensive remission induction chemotherapy is defined as follows: combination therapy with at least 500 mg / m2 of cytarabine and one or more other drugs combined with anthracycline during the treatment period in order to achieve complete remission.
- •(4) Failed to obtain complete remission through one or more intensive induction chemotherapy after either new diagnosis or relapse of acute myeloid leukemia
- •(5) A person deemed unsuitable to receive further intensive chemotherapy at one or more of the following at the time of registration:
- •? there is a clinically significant accompanying disease
- •? Eastern Cooperative Oncology Group Performance Score (ECOG PS) = 2
- •? secondary acute myeloid leukemia
- •? Accompanied by chromosomal or genetic abnormalities suggesting a poor prognosis [according to 2017 European LeukemiaNet Risk Classification Criteria]
- •? investigator judges that intensive reinduction chemotherapy cannot be performed
- •(6) GFR = 30 mL / min, total bilirubin = 3.0 mg / dL, AST and ALT <x5 upper limit of normal (ULN) calculated by Cockcroft-Gault and MDRD method at the time of registration review.
- •(7) Persons who agree with the high efficiency contraception for the duration of treatment and 3 months after termination
- •(8) In the case of women of childbearing age, those who agree not to become pregnant or breast-feeding and who have negative pregnancy test on screening tests.
排除标准
- •(1) Those who are eligible for intensive chemotherapy at the time of review of enrollment
- •(2) Patients with mixed phenotype acute leukemia or acute leukemias of ambiguous lineage
- •(3) patients with acute myeloid leukemia involving the extramedullary central nervous system
- •(4) Patients with acute myeloid leukemia with t (15; 17) chromosomal translocation or PML / RARa gene abnormality or t (9; 22) chromosomal translocation or BCR-ABL1 gene abnormality
- •(5) patients with extramedullary myeloid sarcoma that did not involve bone marrow
- •(6) previously treated with azacitidine or decitabine
- •(7) Liver cirrhosis patients with Child-Pugh Classification B or higher and those with active hepatitis caused by hepatitis B or hepatitis C.
- •-Carriers of HBsAg-positive or HBcAb IgG-positive and without evidence of active hepatitis can be enrolled with appropriate antiviral prophylaxis after HBV DNA testing.
- •Regardless of the hepatitis RNA level, patients positive for hepatitis C antibody can be enrolled if they meet all other criteria and have no evidence of cirrhosis.
- •-Those who have been diagnosed with HCV less than 6 months before enrollment are considered to have acute HCV and excluded unless a viral load is detected.
- •(8) Patients with serious infections that require treatment with antibiotics or antifungal agents and are under control and are not suitable for low-intensity treatment with azacitidine (drug-controlled bacterial infection and invasive pulmonary aspergillosis )
- •(9) Those who have been diagnosed with or are currently on treatment for cancer other than acute myeloid leukemia (breast or prostate cancer or therapeutically resected non-melanoma skin cancer or epithelial cancer that is stable or responsive to endocrine therapy).
- •(10) Those who underwent major surgery within 21 days (excluding laparotomy for lymph nodes, etc.)
- •(11) Hypersensitivity to azacitidine and mannitol, another component of this drug
- •(12) patients with uncontrolled bleeding
- •(13) pregnant and lactating women
- •-Women of childbearing potential must have a negative pregnancy test during the screening period.
研究者
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