A phase II study in patients with fludarabine refractory CLL: Dasatinib treatment combination for Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL) - D’accord study

Academic Medical Center0 个研究点开始时间: 2008年6月2日最近更新: 2012年3月19日

试验速览

暂无简介。

•- CLL confirmed according to the IWCLL Working Group criteria
•- Binet28 stages A or B with indication for treatment according to IWCLL guidelines (appendix A and B) , Binet C AND
•- Fludarabine refractory, defined as relapse (any sign of disease recurrence or progression with or without indication for treatment = 6 months following fludarabine containing chemo(immuno)therapy;
•- Age 18-80 years inclusive;
•- WHO performance status = 2;
•- No possibility for rapid reduced intensity allogeneic hematopoietic stem cell transplantation;
•- At least 4 weeks without any treatment before study entry;
•- Negative pregnancy test;
•- Written 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

•- Richter’s transformation;
•- Suspected or documented CNS involvement by CLL;
•- Grade 3 cytopenia not due to bone marrow infiltration;
•- Concurrent medical condition which may increase the risk of toxicity;
•? Pleural or pericardial effusion of any grade;
•- Severe cardiac Symptoms;
•- Severe pulmonary dysfunction;
•- Active hepatitis B infection;
•- History of significant bleeding disorder unrelated to the CLL;
•- Known HIV positivity;
•- Clinically significant auto-immune hemolytic anemia (AIHA);
•- 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;
•- Any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and follow-up schedule;
•- Female patients of reproductive potential who are not using effective contraception;

发起方

Academic Medical Center