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

NCT02158091 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2026-02-13

Study results available
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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).

Conditions

Interventions

DRUG

IPI-145

oral PI3K delta/gamma inhibitor

DRUG

Fludarabine

intravenous chemotherapy

DRUG

Cyclophosphamide

intravenous chemotherapy

DRUG

Rituximab

intravenous immunotherapy

Sponsors & Collaborators

Principal Investigators

  • Matthew Davids, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-27
Primary Completion
2017-10-31
Completion
2026-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02158091 on ClinicalTrials.gov