Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma

Inclusion Criteria:

- Age ≥ 12 years

- Karnofsky performance score of ≥ 60 (Eastern Cooperative Oncology Group (ECOG)
performance score of 0, 1, or 2)

- Histologically confirmed diagnosis of classic HL (ie, nodular sclerosis, mixed
cellularity, lymphocyte depleted, and or lymphocyte rich types)

- Nodal HL that shows fluorodeoxyglucose (FDG) avidity (defined as focal or diffuse FDG
uptake above background in a location incompatible with normal anatomy or physiology),
and is measurable (defined as the presence of ≥ 1 nodal lesion that measures ≥ 2 cm in
a single dimension as assessed by CT, PET/CT, or magnetic resonance imaging (MRI))

- Relapsed or refractory HL after prior myeloablative therapy with autologous stem cell
transplantation (ASCT) or after ≥ 2 prior chemotherapy-containing regimens and no
curative option with conventional therapy

- Discontinuation of all radiotherapy or chemotherapy for the treatment of HL greater
than or equal to 3 weeks before initiation of study treatment and discontinuation of
all radioimmunotherapy for HL (Visit 2)

- All acute toxic effects (excluding alopecia, neurotoxicity, or anemia) of any prior
antitumor therapy resolved to Grade ≤ 2 before initiation of study treatment (Visit 2)

- For men and women of childbearing potential willingness to abstain from sexual
intercourse or employ an effective method of contraception during the study drug
administration and follow-up periods

- Willingness and ability to provide written informed consent and to comply with
protocol requirements

Exclusion Criteria:

- Known active central nervous system or leptomeningeal lymphoma

- History of a non-lymphoma malignancy except for the following: adequately treated
local basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ,
superficial bladder cancer, localized prostate cancer, other adequately treated Stage
1 or 2 cancer currently in complete remission, or any other cancer that has been in
complete remission for ≥ 5 years

- Evidence of ongoing systemic bacterial, fungal, or viral infection (excluding viral
upper respiratory tract infections) at the time of initiation of study treatment
(Visit 2)

- Pregnancy or breastfeeding

- Ongoing alcohol or drug addiction

- Known history of drug-induced liver injury, chronic active hepatitis C virus (HCV),
chronic active hepatitis B virus (HBV), alcoholic liver disease, non-alcoholic
steatohepatitis, primary biliary cirrhosis, ongoing extrahepatic obstruction caused by
stones, cirrhosis of the liver or portal hypertension

- History of prior allogeneic bone marrow progenitor cell or solid organ transplantation

- Ongoing immunosuppressive therapy, including systemic corticosteroids.

- Prior therapy with idelalisib

- Exposure to another investigational drug within 3 weeks prior to start of study
treatment

- Concurrent participation in another therapeutic treatment trial

- Prior or ongoing clinically significant illness, medical condition, surgical history,
physical finding, ECG finding, or laboratory abnormality that, in the investigator's
opinion, could affect the safety of the patient; alter the absorption, distribution,
metabolism or excretion of the study drug; or impair the assessment of study results

- Prior therapy with any drug that inhibits Akt, Bruton tyrosine kinase (BTK), Janus
kinase (JAK), mammalian target of rapamycin (mTOR), phosphatidylinositol 3 kinase
(PI3K) (including idelalisib), or spleen tyrosine kinase (SYK)