Phase II Study Evaluating the Efficacy and Safety of the Combination of Tagraxofusp and Venetoclax in Treatment-naive Blastic Plasmacytoid Dendritic Cell Neoplasm Patients

Exclusion Criteria

• •1. Participation to another clinical trial with any investigative drug within 30 days prior to study enrolment.
• •2. Previous treatment with venetoclax or tagraxofusp
• •3. Treatment of BPDCN with any prior chemotherapy or investigational agents, except hydroxyurea for less than 14 days at the time of inclusion
• •4. Concomitant immunosuppressive therapy -except for low-dose prednisone (≤10 mg/day)
• •5. Known allergy or sensitivity to tagraxofusp, venetoclax, and any of its components or excipients.
• •6. Pregnant or breastfeeding woman
• •7. Known positivity for hepatitis B or C infection except for those subjects with an undetectable viral load or subjects with serologic evidence of prior vaccination to HBV
• •8. Evidence of uncontrolled systemic infection requiring therapy (viral, bacterial, or fungal)
• •9. Subject has any history of clinically significant condition(s) that in the opinion of the investigator would adversely affect his/her participating in this study including, but not limited to:
• •* Cardiovascular disease e.g., NYHA heart failure \> class 2, uncontrolled angina, history of myocardial infarction, unstable angina, or stroke within 6 months prior to study entry, uncontrolled hypertension, or clinically significant arrythmias not controlled by medication.
• •* Renal, pulmonary, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, or bleeding disorder independent of leukemia.
• •10. Subject with a history of other malignancies within the last three years prior to study entry, except for:
• •* Adequately treated in situ carcinoma of the breast or cervix uteri
• •* Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin
• •* Prostate cancer without needs for specific therapy
• •* Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent.
• •11. Malabsorption syndrome or other conditions that preclude enteral route of administration
• •12. Patient with hereditary fructose intolerance