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

Conditions: Fludarabine-refractory Chronic Lymphocytic Leukemia (CLL)
MedDRA version: 9.1Level: LLTClassification code 10003948Term: B-Lymphocytic, CLL (Kiel Classification) refractory

Registration Number: EUCTR2008-002236-15-NL

Lead Sponsor: Academic Medical Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- 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

Exclusion Criteria

- 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;