Clinical trial NCT02158091 (phase 1/phase 2, status: active, not recruiting)
Conditions: chronic lymphocytic leukemia
ICD codes: C91.11, C91.12, C91.10
Drugs: ipi-145, fludarabine, cyclophosphamide, rituximab
SMILES: C[C@H](NC1=C2N=CNC2=NC=N1)C1=CC2=CC=CC(Cl)=C2C(=O)N1C1=CC=CC=C1, ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1, ClCCN(CCCl)P1(=O)NCCCO1
Eligibility criteria:

        Inclusion Criteria:

          -  confirmed diagnosis of CLL and an indication for treatment as per IW-CLL 2008 criteria

          -  no prior therapy for CLL

          -  age 18-65 -- ECOG performance status ≤1

        Exclusion Criteria:

          -  May not be receiving any other study agents

          -  Known CNS involvement

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Pregnant women are excluded from this study because IPI-145 has the potential for
             teratogenic or abortifacient effects.

          -  Individuals with a history of a different malignancy are ineligible except for the
             following circumstances. disease-free for at least 5 years and deemed to be at low
             risk for recurrence. Individuals with the following cancers are eligible if diagnosed
             and treated with curative intent within the past 5 years: cervical cancer in situ,
             localized prostate cancer, and basal cell or squamous cell carcinoma of the skin

          -  HIV-positive individuals, because of the potential for pharmacokinetic interactions
             with IPI-145

          -  Inadequate hepatic function defined by aspartate aminotransferase (AST) and/or alanine
             aminotransferase (ALT) >2.5 x upper limit of normal (ULN); direct bilirubin >1.5 x
             ULN, unless due to hemolysis or Gilbert's syndrome

          -  Inadequate renal function defined by serum creatinine >1.5 x ULN.

          -  Baseline QTcF >480 ms. NOTE: This criterion does not apply to patients with a left
             bundle branch block

          -  Concurrent treatment with any agent known to prolong the QTc interval

          -  Patients with a history of active tuberculosis within the preceding two years.

          -  Patients who have had a venous thromboembolic event (e.g., PE/DVT) requiring
             anticoagulation and who meet any of the following criteria:

          -  Have been on a stable dose of anticoagulation for <1 month

          -  Have had a Grade 2, 3 or 4 hemorrhage in the last 30 days

          -  Are experiencing continued symptoms from their event

          -  History of alcohol abuse, chronic hepatitis, or other chronic liver disease (other
             than direct CLL liver involvement)

          -  Foods or medications that are strong or moderate inhibitors or inducers of CYP3A taken
             within 1 week prior to study treatment and for the duration of the study

          -  Unable to receive prophylactic treatment for pneumocystis