A Study of Duvelisib in Combination With Rituximab or Obinutuzumab in Subjects With Previously Untreated CD20+ Follicular Lymphoma (CONTEMPO)

This is a two-arm, open-label, Phase 1b/2 trial designed to evaluate the safety and efficacy
of duvelisib in combination with rituximab and duvelisib in combination with obinutuzumab in
subjects with previously untreated CD20+ FL.

The study will be conducted in two parts, a Safety Lead-in (Part 1) followed by a randomized,
2-Stage Design in Part 2. Each treatment arm will be assessed independently for dose limiting
toxicity (DLT) within Part 1.

Inclusion Criteria:

- Diagnosis of CD20+, follicular lymphoma that has not been treated

- CD20-immunophenotyping of tumor to document B-cell follicular lymphoma

- Stage II disease with bulky disease (≥ 7cm lesion), Stage III, or Stage IV disease

- Disease that requires treatment based on the Investigator's opinion (e.g., meets GELF
criteria)

- At least one measurable lesion that is > 1.5 cm in at least one dimension

- Eastern Cooperative Oncology Group (ECOG) performance status <=2 (corresponds to
Karnofsky Performance Status [KPS] >=60%)

Exclusion Criteria:

- Received systemic treatment for lymphoma such as chemotherapy, immunotherapy,
radiotherapy, investigational agents, or radioimmunotherapy.

- Clinical evidence of transformation to a more aggressive subtype of lymphoma or grade
3B follicular lymphoma

- Severe allergic or anaphylactic reaction to any monoclonal antibody therapy, murine
protein, or known hypersensitivity to any of the study drugs

- Prior allogeneic hematopoietic stem cell transplant

- Prior, current or chronic hepatitis B or hepatitis C infection

- Human immunodeficiency virus (HIV) infection or Human T Cell Lymphotropic Virus 1
(HTLV-1) infection