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

Status: Recruiting
Phase: Phase 1/Phase 2
Diagnosis: Leukemia/MDS
NCT ID: NCT02158091 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-193


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).


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth-Israel Deaconess Medical Center

Overall PI:
Matthew Davids, MD, Dana Farber Cancer Institute

Site-responsible Investigators:
Jon Arnason, MD, Beth Israel Deaconess Medical Center

Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

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
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