Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Idelalisib in Japanese Participants With Relapsed or Refractory Indolent B-Cell Non-Hodgkin Lymphomas (iNHL) or Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia; Indolent Non-Hodgkin Lymphoma; Follicular Lymphoma; Small Lymphocytic Lymphoma; Lymphoplasmacytic Lymphoma (With or Without Waldenstrom Macroglobulinemia); Marginal Zone Lymphoma
MeSH terms: Lymphoma; Leukemia; Lymphoma, Non-Hodgkin; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Lymphoma, B-Cell; Waldenstrom Macroglobulinemia
Intervention: Idelalisib
Intervention description: 150 mg tablet(s) administered orally twice daily
Intervention MeSH terms: Idelalisib
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to evaluate the 28-day safety and tolerability, and to
      determine the pharmacokinetics (PK) of idelalisib in Japanese participants with relapsed or
      refractory indolent B-cell non-Hodgkin lymphomas (iNHL) or chronic lymphocytic leukemia
      (CLL).
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participants with mature B-cell malignancies of iNHL including follicular lymphoma,
             small lymphocytic lymphoma, lymphoplasmacytic lymphoma, marginal zone lymphoma, and
             CLL by World Health Organization classification

          -  Must have been born in Japan and must not have lived outside of Japan for > 1 year in
             the 5 years prior to Day 1

          -  Must be able to trace maternal and paternal ancestry of parents and grandparents as
             Japanese

          -  Must have been previously treated with at least 1 regimen for iNHL or CLL and
             currently require treatment

          -  Discontinuation of all therapy (including radiotherapy, chemotherapy, immunotherapy,
             or investigational therapy) for the treatment of iNHL or CLL ≥ 4 weeks prior to Day 1

          -  Eastern Cooperative Oncology Group performance status of 0 or 1

          -  Required baseline laboratory data (within 4 weeks prior to Day 1)

          -  A negative serum pregnancy test for female participants of childbearing potential

          -  Males and females of childbearing potential who engage in heterosexual intercourse
             must agree to use protocol-specified method(s) of contraception.

          -  In the judgment of the investigator, participation in the protocol offers an
             acceptable benefit-to-risk ratio when considering current disease status, medical
             condition, and the potential benefits and risks of alternative treatments for the
             individual's disease.

        Key Exclusion Criteria:

          -  Known histological transformation to an aggressive histology

          -  Known presence of myelodysplastic syndrome

          -  History of iNHL or CLL with central nervous system involvement

          -  Life expectancy < 120 days as per investigator assessment

          -  History of a nonlymphoid malignancy with the following exceptions:

               -  the malignancy has been in remission without treatment for ≥ 5 years prior to Day
                  1, or

               -  carcinoma in situ of the cervix, or

               -  adequately treated basal or squamous cell skin cancer or other localized
                  nonmelanoma skin cancer, or

               -  surgically treated low-grade prostate cancer, or

               -  ductal carcinoma in situ of the breast treated with lumpectomy alone

          -  On-going drug-induced liver injury, alcoholic liver disease, nonalcoholic
             steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by
             cholelithiasis, cirrhosis of the liver, or portal hypertension

          -  History or diagnosis of pneumonitis or interstitial lung disease.

          -  On-going inflammatory bowel disease

          -  Pregnancy or breastfeeding

          -  History of prior allogeneic hematopoietic stem cell or solid organ transplantation

          -  Concurrent participation in another therapeutic clinical trial

          -  Prior or on-going clinically significant illness, medical condition, surgical history,
             physical finding, electrocardiogram finding, or laboratory abnormality that, in the
             investigator's opinion, could adversely affect the safety of the individual or impair
             the assessment of study results.

        Note: Other protocol defined Inclusion/Exclusion criteria may apply.