EUCTR2014-004874-41-SE进行中（未招募）1 期
Safety, Efficacy and Immune Response of Histamine Dihydrochloride and Low-dose Interleukin-2 in Chronic Myelomonocytic Leukemia (CMML)
ordic MDS study group0 个研究点目标入组 15 人开始时间: 2016年6月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •=18 years of age at the time of signing the informed consent form.
- •CMML-1 with indication for treatment according to NMDSG
- •guidelines*.
- •Life expectancy of more than three months and ability to undergo
- •routine outpatient evaluations for efficacy, safety, and compliance.
- •Informed consent obtained and signed.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 7
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •Acute myeloid leukemia.
- •CMML-2 according to WHO criteria.
- •Systemic mastocytosis.
- •Previous or intended allogeneic stem cell transplantation.
- •Concomitant or intended cytostatic or cytoreductive therapy other
- •than hydroxyurea (HU) *.
- •ECOG performance status =3.
- •Platelet count (TPK) <30x109/L
- •NYHA 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, angina pectoris or
- •symptomatic arteriosclerotic blood vessel disease.
- •Other active malignancies except in situ carcinoma of the cervix,
- •localized squamous or basal cell carcinoma of the skin.
- •Serious concurrent or recent non-malignant medical conditions which,
- •in the opinion of the Investigator, makes the patient unsuitable for
- •participation in this study.
- •History of seizures, central nervous system disorders, stroke within
- •the last 12 months, or psychiatric disability thought to be clinically
- •significant in the opinion of the Investigator and adversely affecting
- •compliance to protocol.
- •Serum creatinine > 1.5 times the upper normal limit.
- •Serum aminotransferase (AST), alanine transaminase (ALT) and
- •bilirubin >2.0 times the upper normal limit
- •Active 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 or bleeding.
- •Patients requiring active treatment for hypotension.
- •Patients continuing systemic treatment with clonidine, steroids,
- •receptor blocking agents.
- •Patients with a history of histamine hypersensitivity, severe allergies
- •to food or contrast media requiring treatment within the last five years.
- •Pregnancy. Women of childbearing potential (WCBP) and males
- •having intercourse with WCBP must agree to comply with using an
- •effective contraceptive method for the duration of the treatment (WCBP
- •is a sexually mature woman who is not surgically sterile or has not been
- •naturally postmenopausal for at least 12 consecutive months).
- •* Note that treatment with HU is allowed if treatment has been ongoing
- •for at least 3 months prior to enrollment. The use of HU is also allowed
- •to control myeloproliferation after starting study treatment, preferably
- •during resting periods Please refer to section 9.
研究者
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