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Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Active, not recruiting · Phase 3 · NCT02048813

Conditions: Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma

At a glance

Research payments reported, 2025
$14.2M
U.S. investigators named
1
Sites paid
1
Planned or actual enrollment
529

About the trial

Sponsor
National Cancer Institute (NCI)
Tested
Cyclophosphamide (drug), Fludarabine Phosphate (drug), Ibrutinib (drug), Laboratory Biomarker Analysis (other), Pharmacogenomic Study (other), Quality-of-Life Assessment (other), Rituximab (biological)
Dates
Started 2014-03-10; completion 2026-10-09
Results posted
Yes

This phase III trial studies ibrutinib and rituximab to see how well they work compared to fludarabine phosphate, cyclophosphamide, and rituximab in treating patients with untreated chronic lymphocytic leukemia or small lymphocytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell)…

From ClinicalTrials.gov, last updated 2026-08-28. Full record, eligibility and contacts (opens in a new tab)

Industry funding

AbbVie Inc. reported $14.2M in research payments for this study in 2025 (12 payments).

Products named: Imbruvica

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.

U.S. investigators named on this study

Clinicians the company named as principal investigators in its Open Payments reports.

Sites paid to run it

  • National Institute of Health $14.2M

Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.