NCT01305460已完成1 期
A Phase I/II Study of the Efficacy and Safety of an Intensified Schedule of Azacitidine (Vidaza®) in Intermediate-2 and High Risk MDS Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 21
- 主要终点
- Response rate (including CR and PR) according to IWG 2006 criteria for MDS after 4 and 8 cycles 75mg/m2/d azacitidine administered every 2 weeks.
研究概览
简要总结
A phase I/II study of the efficacy and safety of an intensified schedule of Azacitidine (Vidaza®) in intermediate-2 and high risk MDS patients.
详细描述
The study is an open-label, multicenter phase I/II study.
Treatment Regimen, Dosage and Duration:
Treatment will consist of azacitidine 75mg/m2/d for 5 days every 14 days for 4 cycles (azacitidine-14, cycles 1-4).
- Patients achieving CR or PR will be then treated with 4 cycles of azacitidine 75mg/m2/d for 5 days administered every 21 days (azacitidine-21, cycles 5 to 8) followed by cycles of azacitidine 75mg/m2/d for 7 days administered every 28 days (azacitidine-28, cycles 9 and beyond), to be continued until progression/relapse or toxicity arises).
- Patients not obtaining CR or PR after the initial 4 cycles of azacitidine-14 will continue to receive azacitidine 75mg/m2/d for 5 days every 14 days for 4 additional cycles (cycles 5 to 8). If they achieve CR, PR or HI after 8 cycles, they will then be treated with azacitidine 75mg/m2/d for 5 days every 21 days (azacitidine-21, cycles 9 to 12) and subsequently cycles of azacitidine 75mg/m2/d for 7 days administered every 28 days (azacitidine-28, cycles 13 and beyond) until progression/relapse or toxicity arises.
- Patients not obtaining CR, PR or HI after 8 cycles of azacitidine-14 will go "off-study".
Number of patients to be included:
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MDS defined according to WHO classification (also including RAEB-T according to FAB classification) (see appendix 1) with intermediate-2 or high risk IPSS (see appendix 1).
- •Age ≥ 18 years and <75 years.
- •Must understand and voluntarily sign an informed consent form.
- •Must be able to adhere to the study visit schedule and other protocol requirements.
- •Patients must have ECOG performance status (PS) of 0 - 2, and no major comorbidities preventing administration of an intensified regimen of azacitidine.
- •Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must :
- •Have a negative serum or urine pregnancy test within 2 weeks prior to beginning treatment on this study. Lactating patients are excluded.
- •Agree to use, and to be able to comply with, effective contraception without interruption, 4 weeks before starting study drug throughout the entire duration study drug therapy (including doses interruptions) and for 3 months after the end of the study drug therapy.
- •Male patients must :
- •Agree the need for the use of a condom if engaged in sexual activity with a woman of childbearing potential during the entire period of treatment, even if disruption of treatment and during 3 months after end of treatment.
- •Agree to learn about the procedures for preservation of sperm before starting treatment.
- •Creatinine < 1.5 N or estimated clearance of creatinine above 30 ml/min.
- •Serum aspartate aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) < 3.0 x upper limit of normal (ULN).
- •Serum total bilirubin < 1.5 mg/dL. (except for unconjugated hyperbilirubinemia due to Gilbert's disease or secondary to MDS-related dyserythropoiesis).
- •Health insurance
排除标准
- •Patients with a history of myeloproliferative syndrome or CMML.
- •Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C.
- •Pregnant and lactating patients are excluded because the effects of azacitidine on a fetus or a breast-fed child are unknown.
- •Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure (NYHA > II), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy in the last 8 weeks
- •Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities of an intensified regimen of azacitidine.
- •Less than 6 months since prior allogeneic bone marrow transplantation.
- •Less than 3 months since prior autologous bone marrow or stem cell transplantation
- •Active cancer or prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for ≥ 3 years.
- •Prior treatment with azacitidine.
- •Known allergy/intolerance to azacitidine or mannitol.
- •Life expectancy of less than 3 months.
研究组 & 干预措施
Azacitidine intensified dose
Experimental
干预措施: Azacitidine (Drug)
结局指标
主要结局
Response rate (including CR and PR) according to IWG 2006 criteria for MDS after 4 and 8 cycles 75mg/m2/d azacitidine administered every 2 weeks.
时间窗: 2 months
After 4 courses treatment
次要结局
- Responses (CR, PR, marrow CR, HI) according to IWG 2006 criteria and their duration.(2-4 months)
- Overall survival and progression (IPSS/AML) free survival.(2 months and further)
- Safety/toxicity profile of azacitidine administered every 14 days (NCI-CTAE)(1-24 months)
研究者
研究点 (21)
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