NCT02158091

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

A Phase 1b/2 Study of IPI-145 in Combination With Fludarabine, Cyclophosphamide, and Rituximab (iFCR) in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia.

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Patients who fulfill eligibility criteria will be entered into the trial to receive IPI-145 in combination with the standard drugs fludarabine, cyclophosphamide, and rituximab (FCR). After the screening procedures confirm participation in the research study: Phase I The investigators are looking for the highest dose of the combination of study drugs that can be administered safely without severe or unmanageable side effects in participants that have CLL. Not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study prior and how well the dose was tolerated. Phase II: Patients treated with IPI-145 at the Recommended Phase II Dose (RP2D) + fludarabine, cyclophosphamide, rituximab (FCR) with standard dosing.

Conditions

• Chronic Lymphocytic Leukemia

Interventions

Type	Name	Description
DRUG	IPI-145	oral PI3K delta/gamma inhibitor
DRUG	Fludarabine	intravenous chemotherapy
DRUG	Cyclophosphamide	intravenous chemotherapy
DRUG	Rituximab	intravenous immunotherapy

Timeline

• Start date: 2014-06-27
• Primary completion: 2017-10-01
• Completion: 2026-07-01
• First posted: 2014-06-06
• Last updated: 2026-02-13
• Results posted: 2018-12-11

Locations

2 sites across 1 country: United States