EUCTR2010-020341-27-FR进行中（未招募）不适用
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 - GFM-Aza intensif
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
- •MDS defined according to WHO classification (also including RAEB-T according to
- •FAB classification)(see appendix 1) with an intermediate-2 or high risk MDS IPSS
- •score (see appendix 1).
- •Age = 18 years and <70 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:
- •o Have a negative serum or urine pregnancy test within 2 weeks prior to
- •beginning treatment on this study. Lactating patients are excluded.
- •o 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 :
- •o 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.
- •o Agree to learn about the procedures for preservation of sperm before starting
- •Creatinine <1.5 N or estimated clearance of creatinine below 30ml/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.
- •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
- •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
- •foetus or 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 stem cell transplantation.
- •Less than 3 months since prior autologous stem cell transplantation.
- •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.
- •ECOG > 2.
- •Life expectancy less than 3 months.
研究者
相似试验
进行中（未招募）
1 期
ot availableStaphylococcus aereus BacteremiaMedDRA version: 19.1Level: LLTClassification code 10058887Term: Staphylococcus aureus bacteremiaSystem Organ Class: 100000004862EUCTR2015-003510-25-DEXBiotech USA, Inc.52
已完成
1 期
A phase I/II study for the safety and efficacy of Panitumumab in combination with TAS-102 for patients with RAS wild-type metastatic colorectal cancer refractory to standard chemotherapyunresectable advanced colorectal cancerJPRN-UMIN000019876Takeda Pharmaceutical Company Limited52
已完成
1 期
A Phase I/IIa Study of the Efficacy and Safety of ASN-002 Alone and in Combination with 5-Fluorouracil (5-FU) in Adult Patients with Low-Risk Nodular Basal Cell CarcinomaACTRN12615001017516Ascend Biopharmaceutical Ltd.16
进行中（未招募）
1 期
A study to learn about the safety and efficacy of CTX001 (the study drug product) to treat beta-thalassemiaEUCTR2017-003351-38-ITCRISPR Therapeutics AG12
进行中（未招募）
1 期
A study to learn about the safety and efficacy of CTX001 (the study drug product) to treat beta-thalassemiaEUCTR2017-003351-38-GBVertex Pharmaceuticals Incorporated45