EUCTR2010-019709-41-FR进行中（未招募）不适用
A phase I study of azacitidine with Ceplene/interleukin-2 followed by a randomized 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 (MDS) who achieved hematological response to azacitidine. - GFM-Aza-ceplene
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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.Age = 18 years
- •2.Must understand and voluntarily sign an informed consent form
- •3.Must be able to adhere to the study visit schedule and other protocol requirements
- •4.Documented diagnosis of MDS according to WHO classification, that meets IPSS criteria for intermediate-2 or high-risk disease
- •5.Must have achieved a response (CR, PR, mCR or HI according to IWG 2006 criteria) after 6 cycles of Azacitidine.
- •6.Patients must have ECOG performance status (PS) of 0 – 2.
- •7.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
- •8. Creatinine clearance >50 ml/min
- •9.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)
- •10.Serum total bilirubin < 1.5 mg/dL. (except for unconjugated hyperbilirubinemia due to Gilbert’s disease or secondary to MDS).
- •11. Women of child-bearing potential
- •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.
- •12. 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.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Known positive status for human immunodeficiency virus (HIV) or hepatitis B or C
- •2.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
- •3.Patients receiving any other standard or investigational cytotoxic treatment for their hematologic malignancy
- •4.Any medical condition which in the opinion of the investigator places the patient at an unacceptably high risk for toxicities
- •5.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
- •6.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
- •7.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
- •8.Prior history of autoimmune disease (including but not limited to systemic lupus, inflammatory bowel disease, and psoriasis)
- •9.Patients with active peptic or esophageal ulcer disease or with past peptic ulcer or esophageal disease with a history of bleeding
- •10.Patients continuing systemic treatment with clonidine, steroids, and/or H2 receptor blocking agents
- •11.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
- •12. Antecedent of allogeneic bone marrow transplantation
研究者
相似试验
进行中（未招募）
1 期
ordic multicenter phase II study: Treatment of patients with Acute Myeloid Leukemia (AML) with AZACITIDINE and reduced dose of VENETOCLAX (including laboratory research for improvement of AML treatment).Acute myeloid leukemia (AML)MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864EUCTR2020-005461-14-DKRigshospitalet117
进行中（未招募）
1 期
ordic multicenter phase II study: Treatment of patients with Acute Myeloid Leukemia (AML) with AZACITIDINE and reduced dose of VENETOCLAX (including laboratory research for improvement of AML treatment).Acute myeloid leukemia (AML)MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864EUCTR2020-005461-14-FIRigshospitalet117
进行中（未招募）
不适用
A phase II study of the use of azacitidine for the treatment of patients with chronic graft-versus-host-disease who have failed treatment with corticosteroidsChronic Graft versus Host DiseaseMedDRA version: 18.1Level: PTClassification code 10066261Term: Chronic graft versus host diseaseSystem Organ Class: 10021428 - Immune system disordersEUCTR2014-005659-19-GBniversity of Birmingham
终止
2 期
Early phase II study of Azacitidine and Carboplatin priming for Avelumab in patients with advanced melanoma who are resistant to immunotherapy.Metastatic melanomaImmunotherapy resistantCancer - Malignant melanomaACTRN12618000053224niversity of Newastle20
进行中（未招募）
1 期
Phase ll Study of the Adjunctive Use of Azacitidine in Patients Undergoing Reduced Intensity Allogeneic Transplantation for Acute Myeloid Leukaemia - RICAZAEUCTR2007-006475-36-GBniversity of Birmingham40