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

Inclusion criteria

• Histologically confirmed diagnosis of FL or MCL according to WHO 2008
• Relapsed or refractory with at least one (FL) or two (MCL), but not more than four, prior lines of antineoplastic regimens.
• Either FDG-avid on FDG-PET or measurable disease by CT on cross sectional imaging: > 1.5 cm for nodal lesion, > 1.0 cm for extra nodal lesion.
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

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.