Study of Safety and Efficacy of BCL201 and Idelalisib in Patients With FL and MCL

Exclusion Criteria

• •For dose escalation part: Patients with MCL at high risk for tumor lysis syndrome
• •Prior treatment with PI3Kδ or Bcl-2 inhibitors.
• •Any other malignant disease
• •History of serious allergic reactions including anaphylaxis and toxic epidermal necrolysis
• •Inadequate organ function
• •Concomitant treatment with:
• •Strong CYP3A4/5 inducers or inhibitors
• •Sensitive CYP3A4/5 substrates or CYP3A4/5 substrates with narrow therapeutic index (NTI)
• •Sensitive CYP2D6 substrates or CYP2D6 substrates with NTI
• •Selected dual substrates of CYP3A4/5 and CYP2C8
• •Selected dual substrates of CYP3A4/5 and CYP2D6
• •Selected dual substrates of OATP and CYP450
• •Selected dual substrates of CYP3A4/5 and P-gp
• •NTI P-gp substrates
• •QT prolonging drugs with a known risk to induce TdP
• •Proton pump inhibitors
• •Treatment by warfarin or equivalent vitamin K antagonists.
• •Other investigational therapies
• •Herbal preparations/ medications
• •Grapefruit, Seville oranges or products containing either juice
• •Other protocol-defined inclusion/exclusion may apply.