Study Evaluating Safety and Efficacy of INCB050465 Combined With Bendamustine and Obinutuzumab in Relapsed or Refractory Follicular Lymphoma (CITADEL-102)

Inclusion criteria

• Histologically confirmed FL.
• Documented CD20+ FL.
• Relapsed or refractory to any prior rituximab-containing regimen.
• Previously treated with a maximum of 4 cancer-directed treatment regimens.
• At least 1 measurable lesion > 1.5 cm in at least 1 dimension by computed tomography or magnetic resonance imaging.
• Must be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy or provide the most recent, available archived tumor biopsy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion criteria

• Clinical evidence of transformation to a more aggressive subtype of lymphoma or Grade 3B FL.
• History of central nervous system lymphoma (either primary or metastatic).
• Allogeneic stem cell transplant within the last 6 months, or active graft-versus-host disease following allogeneic transplant or autologous stem cell transplant within the last 3 months before the date of the first dose of study drug administration.
• Use of any potent cytochrome P450 3A4 inhibitors or inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study drug.
• Prior treatment with a selective PI3Kδ inhibitor or a pan PI3K inhibitor.
• Prior treatment with bendamustine (within 12 months of the start of study treatment). Subjects with prior bendamustine treatment (> 12 months before the start of study treatment) are eligible if they meet the following criteria:

• Did not discontinue because of tolerability concerns.
• Achieved either partial or CR to the bendamustine regimen of at least 12 months in duration before relapse/progression.
• Experienced progression following a regimen containing an alkylating agent.
• Received prior obinutuzumab.
• Received rituximab within 4 weeks of study start.
• Prior treatment-related toxicities that have not resolved to ≤ Grade 1 before the date of study drug administration except for stable chronic toxicities (≤ Grade 2) not expected to resolve (eg, stable Grade 2 peripheral neurotoxicity).
• Received any prior monoclonal antibody (except an anti-CD20 antibody) within 90 days before the date of study start.
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (eg, subjects in whom re-administration with rituximab would be contraindicated for safety reasons).