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ACTIVE NOT RECRUITING
NCT02251548
PHASE2

A Phase II Study of Ibrutinib Plus FCR in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia

Sponsor: Dana-Farber Cancer Institute

View on ClinicalTrials.gov

Summary

This research study is evaluating a new drug called ibrutinib in combination with the standard drugs fludarabine, cyclophosphamide, and rituximab (FCR) as a possible treatment for Chronic Lymphocytic Leukemia (CLL).

Official title: A Phase II Study of Ibrutinib in Combination With Fludarabine, Cyclophosphamide, and Rituximab (iFCR) in Previously Untreated, Younger Patients With Chronic Lymphocytic Leukemia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

85

Start Date

2014-10

Completion Date

2027-01

Last Updated

2025-10-24

Healthy Volunteers

No

Interventions

DRUG

Ibrutinib

Oral BTK inhibitor

DRUG

Fludarabine

IV purine analogue chemotherapy agent

DRUG

Cyclophosphamide

IV alkylator chemotherapy agent

DRUG

Rituximab

IV anti-CD20 monoclonal antibody

Locations (9)

University of Miami Sylvester Comprehensive Cancer Center

Coral Gables, Florida, United States

University of Miami Sylvester Comprehensive Cancer Center

Deerfield Beach, Florida, United States

Unversity of Miami Sylvester Comprehensve Cancer Center

Miami, Florida, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Duke University Medical Center

Durham, North Carolina, United States