EUCTR2016-002728-94-SE进行中（未招募）1 期
A phase I/II, open-label study of safety, immune activation and efficacy of histamine dihydrochloride and low-dose interleukin-2 in adult tyrosine kinase inhibitor-treated patients with chronic myeloid leukemia
Sahlgrenska University Hospital0 个研究点目标入组 15 人开始时间: 2017年9月21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
- 性别
- All
入选标准
- •1. Patients are able to provide written informed consent
- •2. Patients must have CML treated with TKI for at least 24 months, with no therapy change during the last 6 months or planned therapy change within 6 months, and be in cytogenetic remission, which is defined by the presence of all of the following criteria:
- •Ph+ or variants must have been demonstrated by BM cytogenetics, FISH or PCR at diagnosis
- •Complete hematological remission for at least 12 months prior to inclusion
- •Complete cytogenetic remission on latest bone marrow examination.
- •Minimum 2 RQ-PCR determination below 1% on the IS, i.e. MR2 during the last 12 months.
- •3.ECOG Performance Status (PS) Score 0 - 1 (see Appendix 2)
- •4.Adequate hepatic function defined as: total bilirubin = 2.0 times the institutional upper limit of normal (ULN) in absence of Gilbert type unconjugated hyperbilirubinemia; alanine aminotransferase (ALAT= 2.5 times the institutional ULN.
- •5.Adequate renal function defined as serum creatinine = 2 times the institutional ULN.
- •6.Men and women, ages 18 years and older.
- •7.Potentially fertile women must use an adequate method of contraception to avoid pregnancy throughout the study.
- •8.Potentially fertile women must have a negative serum or urine pregnancy test
- •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 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 15
排除标准
- •For entry into the study, none of the exclusion criteria can be met.
- •1.Fertile women who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study
- •2.Women who are pregnant or breastfeeding.
- •3.Men with fertile sexual partners who can or will not use an acceptable contraception method for the entire study
- •4.A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
- •5.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.
- •6.Prior or concurrent malignancy, except for the following:
- •adequately treated basal cell or squamous cell skin cancer
- •cervical carcinoma in situ
- •adequately treated Stage I or II cancer from which the subject is currently in complete remission
- •any other cancer from which the subject has been disease-free for three years.
- •7.Severe psychiatric illness, imprisonment or mental impairment inflicting on ability to give informed consent.
- •8.Abuse of alcohol, prescribed or illicit drugs
- •9.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.
- •10.Patients unable to undergo repeat treatments, clinical evaluations and other diagnostic procedures required by the protocol.
- •11.Active autoimmune disease (including but not limited to systemic lupus, inflammatory bowel disease, and psoriasis).
- •12.Patients with active peptic or esophageal ulcer disease or with past peptic ulcer or esophageal disease with a history of bleeding.
- •13.Patients requiring active treatment for hypotension.
- •14.Medical, sociologic, or psychological impediment to probable compliance with the protocol.
- •15.Patients unable to stop therapy with H2 antagonists, antihistamines, clonidine, corticosteroids or immunomodulating agents. These drugs should discontinued at least 24 hours prior to initiation of HDC/IL2 therapy and patients should not receive H2 antagonists throughout treatment.
- •16.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.
研究者
相似试验
已完成
1 期
Safety Study of a Liposomal Vaccine to Treat Malignant MelanomaACTRN12610000149066ipotek Pty Ltd24
进行中（未招募）
1 期
A Phase I/IIa Study of the Safety, Immunogenicity and Parasite Growth Inhibitory Activity of AMA1-C1/Alhydrogel® + CPG 7909, an Asexual Blood Stage Vaccine for Plasmodium falciparum Malaria - AMA1-C1/CPG Blood Stage ChallangeEUCTR2007-005389-11-GBniversity of Oxford10
进行中（未招募）
1 期
Aditec Flu 2 Study: Understanding the genetic basis for immune responses to flu vaccines in children and adultsThis trial is investigating healthy children and adult's gene expression and immune response to the Fluad (MF59)-adjuvanted trivalent influenza vaccine and also comparing these to the local and general reactions following vaccine administration. Healthy children will be immunised with 2 doses, adult with 1 dose.EUCTR2015-001648-12-GBniversity of Oxford120
进行中（未招募）
1 期
Study to determine the safety and immunogenicity of COVID-eVax, a vaccine for COVID-19 in healthy adult volunteers.COVID-19 prevention.MedDRA version: 23.0Level: LLTClassification code 10053983Term: Corona virus infectionSystem Organ Class: 100000004862EUCTR2020-003734-20-ITTakis S.r.l.160
进行中（未招募）
1 期
A Phase I/II study to assess the safety and immunogenicity of recMAGE-A3+AS15 cancer immunotherapeutic given as adjuvant therapy, with or without adjuvant chemo(-radio)therapy, to patients with MAGE-A3-positive Non-Small Cell Lung cancer (stage IB, II or III) - MAGE3-AS15-NSC-001on-Small Cell Lung CancerMedDRA version: 6.1Level: PTClassification code 10061873EUCTR2006-004777-10-ITGlaxoSmithKline Biologicals70