DNA Plasmid Encoding a Modified Human Telomerase Reverse Transcriptase (hTERT), Invac-1 in Chronic Lymphocytic Leukemia

Exclusion Criteria

• •1. Any investigational agent(s) within 4 weeks prior to entry
• •2. Uncontrolled autoimmune hemolytic anemia (Hgb \< 11g/deciliter) or idiopathic thrombocytopenic purpura (\< 100,000/µl)
• •3. Any previous treatment (chemotherapy, radiotherapy, and/or monoclonal antibodies) intended specifically to treat CLL
• •4. Treatment with corticosteroids other than physiological replacement within the previous week or treatment with immunosuppressive medication within the previous week.
• •5. Major surgery within 4 weeks prior to inclusion
• •6. Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 6 months prior to inclusion
• •7. Uncontrolled active systemic fungal, bacterial, viral, or other infection or requirement for intravenous (IV) antibiotics
• •8. Known history of infection with human immunodeficiency virus (HIV)
• •9. Serologic status reflecting active hepatitis B or C infection.
• •10. History of stroke or intracranial hemorrhage within 6 months prior to enrolment
• •11. Current life-threatening illness, medical condition, or organ-system dysfunction that could compromise patient safety or put the study at risk
• •12. Breast-feeding or pregnant women, or patients for whom there is a risk of conception and who are unable or unwilling to use appropriate contraception (for male and female patients up to 4 months after end of ibrutinib.)
• •13. Previous malignancy with life expectancy less than 6 months or requiring systemic treatment (except colorectal cancer, history of basal cell carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
• •14. Known drug abuse/ alcohol abuse
• •15. Severe organ failures or diseases, including: clinically relevant coronary disease, myocardial infarction or any other relevant cardiovascular disorder within 12 months before study entry, severe psychiatric illness and severe infection.
• •Group 2: Ibrutinib treated patients
• •1. Any investigational agent(s) within 4 weeks prior to entry
• •2. Known involvement of the central nervous system by lymphoma or leukemia
• •3. History or current evidence of Richter's transformation or prolymphocytic leukemia
• •4. Uncontrolled autoimmune hemolytic anemia (Hgb \< 11g/deciliter) or idiopathic thrombocytopenic purpura (\< 100,000/µl)
• •5. More than one previous treatment by chemotherapy or patients who previously received alemtuzumab intended specifically to treat CLL
• •6. Corticosteroid use within 1 week prior to first dose of study drug, with the exception of inhaled, topical, or other local administrations. Patients requiring systemic steroids at daily doses \> 20 mg prednisone (or corticosteroid equivalent), or those who are administered steroids for leukemia control or white blood cell (WBC)-count-lowering are excluded
• •7. Major surgery within 4 weeks prior to inclusion
• •8. Currently active, clinically significant cardiovascular disease or a history of myocardial infarction within 6 months prior to inclusion
• •9. Uncontrolled active systemic fungal, bacterial, viral, or other infection or requirement for intravenous (IV) antibiotics
• •10. Known history of infection with human immunodeficiency virus (HIV)
• •11. Serologic status reflecting active hepatitis B or C infection
• •12. History of stroke or intracranial hemorrhage within 6 months prior to enrollment
• •13. Current life-threatening illness, medical condition, or organ-system dysfunction that could compromise patient safety or put the study at risk
• •14. Requirement for anticoagulation with warfarin, or for treatment with a strong CYP3A4/5 and/or CYP2D6 inhibitor
• •15. Breast-feeding or pregnant women, or patients for whom there is a risk of conception and who are unable or unwilling to use appropriate contraception (for male and female patients up to 4 months after end of ibrutinib.)
• •16. Previous malignancy with life expectancy less than 6 months or requiring systemic treatment (except colorectal cancer, history of basal cell or squamous carcinoma of skin or pre-invasive carcinoma of the cervix with adequate treatment)
• •17. Known drug abuse/ alcohol abuse
• •18. Severe organ failures or diseases, including: clinically relevant coronary disease, myocardial infarction or any other relevant cardiovascular disorder within 12 months before study entry, severe psychiatric illness and severe infection.