NL-OMON37297
Not yet recruiting
Phase 2
Dasatinib treatment combination for fludarabine-refractory Chronic Lymphocytic Leukemia (CLL) - D'accord study (Dasatinib Combination for CLL with Refractory Disease)
AMC afdeling hematologie0 sites35 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- chronic lymphocytic leukenia
- Sponsor
- AMC afdeling hematologie
- Enrollment
- 35
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- 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;
Exclusion Criteria
- •\- 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;
Outcomes
Primary Outcomes
Not specified
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