Clinical-biological Characteristics and Outcome of Chronic Lymphocytic Leukemia Under Ibrutinib-named Patient Program

Inclusion Criteria

• •1. Patients ≥18 years of age.
• •2. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
• •3. A minimum of one prior line of systemic chemotherapy, chemo-immunotherapy, or an alemtuzumab-based regimen, consisting of at least two cycles of therapy.
• •4. Relapsed or refractory CLL with one or more of the following criteria:
• •* Presence of deletion of the short-arm of chromosome 17 (ie 17p deletion).
• •* Relapsed: Failed two or more previous treatments, at least one with a purine analogue such as fludarabine.
• •* Relapsed: Progression-free interval of less than 24 months from completing treatment with a nucleoside analogue, or bendamustine-containing regimen in combination with an anti-CD20 monoclonal antibody such as rituximab.
• •* Refractory: Failure to respond to a prior chemotherapy-based treatment, stable disease, or disease progression while on treatment.
• •5. Patient has active CLL requiring treatment as defined by the IWCLL 2008 criteria. A minimum of one of the following criteria is required:
• •* Evidence of progressive marrow failure, as manifested by the development of, or worsening of, anemia or thrombocytopenia.
• •* Massive (at least 6 cm below the left costal margin), progressive, or symptomatic splenomegaly.
• •c. Massive nodes (at least 10 cm in longest diameter), progressive, or symptomatic lymphadenopathy.
• •* Progressive lymphocytosis with an increase of more than 50% over a 2-month period or a lymphocyte doubling time of less than 6 months (which may be extrapolated). For patients with initial blood lymphocyte counts of less than 30 x 109/L (30,000/mL), lymphocyte doubling time should not be used as a single parameter to define indication for treatment. Factors contributing to lymphocytosis or lymphadenopathy other than CLL (e.g., infections) should be excluded.
• •* Constitutional symptoms, defined as 1 or more of the following disease-related symptoms or signs:
• •i. Unintentional weight loss \>10% within the previous 6 months prior to screening.
• •ii. Significant fatigue (inability to work or perform usual activities). iii. Fever higher than 38.0°C for 2 or more weeks without evidence of infection.
• •iv. Night sweats for more than 1 month without evidence of infection.
• •6. Haematology values within the following parameters:
• •* Absolute neutrophil count (ANC) of ≥0.75 x109/L independent of growth factor support.
• •* Platelet count of ≥30 x109/L independent of platelet support.
• •7. Biochemical values within the following limits:
• •* Serum creatinine ≤2 times the upper limit of normal (ULN) or estimated glomerular filtration rate (GFR \[Crockcoft-Gault\]) ≥30 mL/minute.
• •* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 times ULN.
• •* Total bilirubin ≤1.5 times ULN (unless the bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin) for whom the upper limit of serum bilirubin is 3 mg/dl.
• •8. No problems to swallowing regularly capsules.
• •9. Agreed to practice a highly effective method of birth control during and after participation in the NPP if they are of childbearing potential and sexually active.
• •10. Signed informed consent document (if feasible) indicating that they understand the purpose of the study, they agree to give complete access to their medical records.