A Phase 1b/2 Study of IPI-145 Plus FCR in Previously Untreated, Younger Patients With CLL

This research study is evaluating a new drug called IPI-145 in combination with the standard drugs fludarabine, cyclophosphamide, and rituximab (FCR), as a possible treatment for chronic lymphocytic leukemia (CLL).

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 \