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 人开始时间: 2014年11月7日最近更新: 2018年2月12日

适应症

试验速览

暂无简介。

•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
•Number of subjects for this age range: 1
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 111
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 111

•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.

发起方

AIL CATANIA ASSOCIAZIONE ITALIANA CONTRO LEUCEMIE-LINFOMI E MIELOMA ONLUS