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

• Status: Active, not recruiting
• Trial end date: 2030-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Infinity Pharmaceuticals, Inc.; Verastem, Inc.
• Treatments: Cyclophosphamide; Fludarabine; Fludarabine phosphate; Rituximab; Vidarabine

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