Duvelisib With Obinutuzumab in Patients With CLL/SLL Previously Treated With a BTKi (SYNCHRONY)

This is a Phase 1b, open-label, dose escalation, safety and tolerability study of Duvelisib
(IPI-145) in combination with obinutuzumab in subjects with Chronic Lymphocytic
Leukemia/Small Lymphocytic Lymphoma previously treated with a BTKi therapy.

Inclusion Criteria:

- ≥18 years of age

- Diagnosis of Chronic lymphocytic leukemia or Small lymphocytic lymphoma that meets at
least one of the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008
criteria for treatment (Binet Stage ≥ B and/or Rai Stage ≥ I with symptoms)

- Measurable disease with a lymph node or tumor mass >1.5 cm in at least one dimension
as assessed by computed tomography (CT)

- Previous exposure to BTKi therapy and meets at least one of the below criteria:

- Progressive disease while receiving a BTKi therapy, or stable disease as best
response after 12 months of receiving a BTKi therapy

- Discontinued a BTKi therapy due to BTKi treatment-related intolerance

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (corresponds to
Karnofsky Performance Status [KPS] ≥60%)

- Subjects must be able to receive outpatient treatment and laboratory monitoring (where
specifically indicated) at the institution that administers study drug for the entire
treatment period

Exclusion Criteria:

- Richter's transformation or prolymphocytic leukemia

- Refractory to obinutuzumab (defined as progression or relapse <12 months of receiving
obinutuzumab monotherapy or <24 months of receiving an obinutuzumab-containing
regimen)

- Progressive disease while previously receiving a PI3K inhibitor (e.g. GS-1101
[idelalisib], duvelisib) or a serious/severe AE related to PI3K inhibitor treatment

- History of severe reaction to prior monoclonal antibody therapy (defined as a Grade 4
event and/or requiring permanent discontinuation)

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

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

- History of tuberculosis treatment within the preceding 2 years