Study Evaluating Safety and Efficacy of Parsaclisib 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).