Arrest Imatinib or Dasatinib in CML patients with Deep Molecular Responses” (AID MORE) - AID MORE

AIL CATANIA ASSOCIAZIONE ITALIANA CONTRO LEUCEMIE-LINFOMI E MIELOMA ONLUS0 个研究点目标入组 222 人2014年11月7日

概览

阶段: 1 期
干预措施: 未指定
疾病 / 适应症: Chronic phase CML patients with BCR-ABL/ABLIS transcript levels below MR3 (<0.1%) and aboveMR4.5 (>0.0032%) at the time of accrual.
发起方: AIL CATANIA ASSOCIAZIONE ITALIANA CONTRO LEUCEMIE-LINFOMI E MIELOMA ONLUS
入组人数: 222
状态: 进行中（未招募）
最后更新: 8年前

暂无简介。

注册库

who.int

开始日期

2014年11月7日

结束日期

待定

最后更新

8年前

研究类型

Interventional clinical trial of medicinal product

性别

All

发起方

AIL CATANIA ASSOCIAZIONE ITALIANA CONTRO LEUCEMIE-LINFOMI E MIELOMA ONLUS

•1\. Chronic phase CML patients with BCR\-ABL/ABLIS transcript levels below MR3 (\<0\.1%) and above MR4\.5 (\>0\.0032%) at the time of accrual. BCR\-ABL/ABLIS transcripts will be validated in the
•Laboratory of Experimental Oncology and Hematology directed by the Coordinator Center. MR3 must be confirmed by 2 consecutive RT\-Q\-PCR with MR3\.
•2\. Female or male \>18 years of age at the time of accrual.
•3\. Patients currently receiving IM 400 mg/qd as the first line of treatment for no less than 3 months.
•Prior exposure to Hydroxyurea is permitted.
•4\. Female patients of childbearing potential, and male patients, must agree to use an effective
•barrier method of birth control, as appropriate, throughout the study and for up to 24 months
•following TKI discontinuation.
•5\. Written informed consent will be signed prior to any study procedures being performed.
•Are the trial subjects under 18? no

•1\. Prior treatment with a TKI other than IM or Interferon.
•2\. Known severe hypersensitivity to DAS treatment or any of the excipients of this product.
•3\. Previous history of Pulmonary Arterial Hypertension or Pleural Effusions.
•4\. Any medical condition that might be aggravated by treatment or that can not be controlled: i.e.
•active infection, unstable diabetes mellitus or all serious concomitant disorders incompatible with
•the study including active autoimmune disorders.
•5\. Concurrent treatment with any other experimental or anti\-cancer therapy.
•6\. Patients with a history of other malignancies, except if there is a disease\-free interval of at least 5
•7\. Women who are pregnant or breast feeding, or of childbearing potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test at the enrollment. Post\-menopausal women must have amenorrhoea for at least 12 months to be considered of non\-childbearing potential.
•8\. Patients with overt cognitive dysfunctions hampering a self\-reported QoL evaluation.