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

NCT02251548 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2025-10-24

Study results available
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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).

Conditions

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

Sponsors & Collaborators

  • Pharmacyclics LLC.

    collaborator INDUSTRY

  • The Leukemia and Lymphoma Society

    collaborator OTHER

  • Blood Cancer Research Partnership

    collaborator OTHER

  • Dana-Farber Cancer Institute

    lead OTHER

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
2014-10-31
Primary Completion
2025-01-31
Completion
2027-01-31

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 NCT02251548 on ClinicalTrials.gov