Safety and Efficacy of Idelalisib in Relapsed or Refractory Hodgkin Lymphoma
Condition: Hodgkin Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Intervention: Idelalisib
Intervention description: Idelalisib tablets administered orally
Intervention MeSH terms: Idelalisib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: HL; idelalisib; CAL-101; GS-1101; PI3K

Summary:

      This study will evaluate the efficacy and safety of idelalisib in participants with relapsed
      of refractory Hodgkin Lymphoma (HL). The primary objective will be to assess the overall
      response rate.

      Eligible participants will initiate oral therapy with idelalisib at a starting dose of 150 mg
      twice daily. Treatment with idelalisib will continue until tumor progression or unacceptable
      toxicity.
    

Eligibility criteria:

        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)