Dasatinib treatment combination for fludarabine-refractory Chronic Lymphocytic Leukemia (CLL) - D'accord study (Dasatinib Combination for CLL with Refractory Disease)

AMC afdeling hematologie0 个研究点目标入组 35 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

暂无简介。

•- CLL confirmed according to the IWCLL Working Group criteria;
•- Binet stages A or B with indication for treatment according to IWCLL guidelines, or Binet C AND
•- Fludarabine refractory, defined as relapse within 6 months following fludarabine containing chemo(immuno)therapy;
•- Age 18-80 years inclusive;
•- WHO performance status * 2;

•- Richter*s transformation;
•- Suspected or documented CNS involvement by CLL;
•- Severe cardiovascular disease (arrhythmias requiring chronic treatment, congestive heart failure, symptomatic ischemic heart disease or prolonged QT interval);
•- Severe pulmonary dysfunction (CTCAE grade III-IV);
•- Severe neurological or psychiatric disease;
•- Significant hepatic dysfunction (serum bilirubin or transaminases * 3 times normal level) except when caused by leukemic infiltration;
•- Significant renal dysfunction (creatinine clearance < 30 ml/min after rehydration);
•- History of active malignancy during the past 5 years with the exception of basal carcinoma of the skin or stage 0 cervical carcinoma;
•- Concurrent use of CYP3A4 inducers or inhibitors, or QTc-prolonging agents;
•- Active, uncontrolled infections;
•- Female patients of reproductive potential who are not using effective contraception;

发起方

AMC afdeling hematologie