Clinical trial NCT02242045 (phase 1, status: completed)
Conditions: chronic lymphocytic leukemia, indolent non-hodgkin lymphoma, follicular lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma (with or without waldenstrom macroglobulinemia), marginal zone lymphoma
ICD codes: C91.11, C91.12, C91.10, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S, S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: idelalisib
SMILES: [H][C@@](CC)(NC1=NC=NC2=C1N=CN2)C1=NC2=CC=CC(F)=C2C(=O)N1C1=CC=CC=C1
Eligibility criteria:

        Key Inclusion Criteria:

          -  Subjects with mature B-cell malignancies of indolent non-Hodgkin lymphoma including
             follicular lymphoma, small lymphocytic lymphoma, lymphoplastic lymphoma, marginal zone
             lymphoma, and chronic lymphocytic leukemia 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 subjects 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.