EUCTR2004-000881-10-LT进行中（未招募）不适用
International, multicenter, randomised, open-labeled, 2-arm - Phase III Study comparing Imatinib (STI571, Glivec®) Standard Dose (400 mg/day) with Imatinib High Dose Induction (800 mg/day) followed by Imatinib Standard Dose Maintenance (400 mg/day) in pretreated Ph+/BCR-ABL+ CML Patients in Chronic Phase - ISTAHIT
CELSG (Central European Leukemia Study Group)0 个研究点目标入组 240 人开始时间: 2005年2月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
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 ³ 18 years of age.
- •2.BCR-ABL positive CML patients in chronic phase, confirmed by caryotype (Ph+) or RT-PCR.
- •3.Patients pretreated with any drug that is known to control the disease of CML in chronic phase except Imatinib (Glivec®).
- •4.Patients without a major cytogenetic response at study entry (>35 % Ph+ metaphases in bone marrow cytogenetic analysis performed < 3 months before study entry).
- •5.Patients either intolerant to Interferon-a (non-hematologic toxicity grade 3-4 for more than 2 weeks) or having received pretreatment for CML at least 12 months before study entry.
- •6.WHO Status 0-2.
- •7.Adequate end organ function, defined as the following: Total bilirubin < 1.5 x ULN, SGOT and SGPT < 2.5 x ULN, creatinine < 1.5 x ULN, ANC > 1.5 x 109/L, platelets > 100 x 109/L.
- •8.Female patients of childbearing potential must have negative pregnancy test within 7 days before initiation of study drug dosing. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients of reproductive potential must agree to employ an effective barrier method of birth control throughout the study and for up to 3 months following discontinuation of study drug.
- •9.Written voluntary informed consent.
- •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.Patients eligible for allogeneic bone marrow transplantation.
- •2.Patients in accelerated phase or blast crisis.
- •3.Known tuberculosis or other uncontrolled infection.
- •4.Other primary tumor of a different histological origin than the study indication (unless the relapse-free interval is > 5 years, and with the exception of cervical carcinoma in situ (CIS), basal cell epithelioma or squamous cell carcinoma of the skin).
- •5.Major surgery within the last 14 days.
- •6.Known to be HIV positive.
- •7.Unstable medical disorder (except for indication) that excludes the patient in the opinion of the investigator.
- •8.Patient has received any other investigational agents within 28 days of first day of study drug dosing.
- •9.Patients with an WHO Performance Status Score > 3 (see Table Section 8.1).
- •10.Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study).
- •11.Female patients who are pregnant or breast-feeding.
- •12.Refusal by female patients of child bearing age to use a safe contraceptive.
- •13.Patient with known chronic liver disease (i.e. chronic active hepatitis, and cirrhosis).
- •14. Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
研究者
相似试验
进行中（未招募）
1 期
PALbociclib rechallenge in hormone receptor-posItive/HER2-negative advanced breast cancer (PALMIRA)Hormone receptor-positive/HER2-negative Advanced Breast CancerMedDRA version: 21.1Level: LLTClassification code 10072737Term: Advanced breast cancerSystem Organ Class: 100000004864EUCTR2017-002781-48-DEMedica Scientia Innovation Research (MedSIR)198
进行中（未招募）
不适用
A observational study of efficacy and safety of medicinal drugs Dalteparin Sodium, solution for intravenous and subcutaneous administratioCTRI/2016/10/007400JSC Pharmasyntez190
尚未招募
不适用
Efficacy and Safety of the Drug Product CaspofungiCTRI/2017/04/008362JSC Pharmasyntez Russia244
已完成
不适用
To compare effectiveness and drug safety of Flusal, aerosol for inhalation metered dose and Seretide®, inhalation aerosol metered dose in patients with uncontrolled and partially controlled bronchial asthmaCTRI/2015/11/006380OOO Rus Biopharm120
进行中（未招募）
1 期
_EUCTR2014-002560-33-FRICANCER180