临床试验/NCT01324960

NCT01324960撤回1 期

A Phase I and Phase II Study of the Efficacy and Safety of Maintenance Treatment With Azacitidine With or Without Ceplene/Interleukin-2 in Patients With Higher Risk Myelodysplastic Syndromes Who Achieved Hematological Response to Azacitidine

Groupe Francophone des Myelodysplasies28 个研究点分布在 1 个国家开始时间: 2011年3月最近更新: 2014年3月20日

适应症

干预措施

试验速览

阶段: 1 期
状态: 撤回
发起方: Groupe Francophone des Myelodysplasies
试验地点: 28
主要终点: Time to progression according to IWG2006 criteria

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

A phase I study of azacitidine with Ceplene/interleukin-2 will first evaluate the safety and tolerability of this regimen in patients with higher risk myelodysplastic syndromes (MDS) who achieved a hematological response after 6 cycles of azacitidine. After approval by an independent Data Safety Monitoring Board (DSMB), the phase I study will be followed by an open label randomized phase II study designed to characterize the efficacy, safety, and tolerability of the addition of Ceplene/interleukin-2 to azacytidine in patients with higher risk myelodysplastic syndrome (MDS) who achieved a hematological response after 6 cycles of azacitidine.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Age ≥ 18 years
•Must understand and voluntarily sign an informed consent form
•Must be able to adhere to the study visit schedule and other protocol requirements
•Documented diagnosis of MDS according to WHO classification, that meets IPSS criteria for intermediate-2 or high-risk disease
•Must have achieved a response (CR, PR, mCR or HI according to IWG 2006 criteria) after 6 cycles of Azacitidine.
•Patients must have ECOG performance status (PS) of 0 -
•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. Nursing patients are excluded.
•Creatinine clearance >50 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).

排除标准

•Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
•Uncontrolled intercurrent illness including, but not limited to uncontrolled infection, symptomatic congestive heart failure, 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
•Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
•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
•Class III or IV cardiac disease, hypotension or severe hypertension, vasomotor instability, serious or uncontrolled cardiac dysrhythmias (including ventricular arrhythmias) at any time, acute myocardial infarction within the past 12 months, active uncontrolled angina pectoris or symptomatic arteriosclerotic blood vessel disease
•History of seizures, central nervous disorders, stroke within the last 12 months, or psychiatric disability thought to be clinically significant in the opinion of the investigator
•Prior history of autoimmune disease (including but not limited to systemic lupus, inflammatory bowel disease, and psoriasis)
•Patients with active peptic or esophageal ulcer disease or with past peptic ulcer or esophageal disease with a history of bleeding
•Patients continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents Patients with a history of hypersensitivity to histamine or histamine products, severe allergies to food or contrast media requiring treatment within the last five years.

研究组 & 干预措施

Ceplene® / IL2 + Azacitidine

Experimental

Azacitidine 75 mg/m2 subcutaneously daily for 7 days every 4 weeks. Ceplene® / IL2: Patients will receive Ceplene (EpiCept Corporation, Tarrytown, NY) at 0.5 mg subcutaneous twice daily and human recombinant IL-2 (aldesleukin; Novartis) 16 400 U/kg subcutaneous twice daily during 15 days for up to 10 cycles, on days 8 to 21 of AZA cycles.

干预措施: Ceplene®, IL-2, Azacitidine (Drug)

Azacitidine

Active Comparator

Azacitidine 75 mg/m2 subcutaneously daily for 7 days every 4 weeks

干预措施: Azacitidine (Drug)

结局指标

主要结局

Time to progression according to IWG2006 criteria

时间窗: Every 4 cycles (during average 2 years)

Progression will be assessed by monitoring the bone marrow, blood and hematologic supportive care according IWG 2006 criteria .

次要结局

Types and numbers of adverse events occuring in all treated patients(Every cycle, during the follow-up on average during 2 years)
Improvement of the quality and the duration of responses compared to maintenance with AZA alone(While patient is on study, during follow up on average during 2 years)

研究者

发起方

Groupe Francophone des Myelodysplasies

申办方类型

Other

研究点 (28)

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