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Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas
NCT03220022 · View on ClinicalTrials.gov ↗
Study Summary
This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymphomas. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride, 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. Giving ibrutinib and etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride may work better in treating patients with HIV-positive diffuse large B-cell lymphomas.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Doxorubicin Hydrochloride
- DRUG Etoposide
- BIOLOGICAL Filgrastim
- DRUG Ibrutinib
Study Locations (19)
New York
- Mount Sinai Hospital — New York
- Memorial Sloan Kettering Cancer Center — New York
- Montefiore Medical Center - Moses Campus — The Bronx
- Memorial Sloan Kettering Nassau — Uniondale
California
- UC San Diego Moores Cancer Center — La Jolla
- UCSF Medical Center-Parnassus — San Francisco
Florida
- University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami
- Memorial Hospital West — Pembroke Pines
Illinois
- John H Stroger Jr Hospital of Cook County — Chicago
- University of Illinois College of Medicine - Chicago — Chicago
Missouri
- Siteman Cancer Center at Washington University — St Louis
- Washington University School of Medicine — St Louis
Pennsylvania
- Pennsylvania Hospital — Philadelphia
- Fox Chase Cancer Center — Philadelphia
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center — Baltimore
Massachusetts
- Boston Medical Center — Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-03-16 |
| Est. Completion | 2026-07-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03220022
The ClinicalTrials.gov registry entry for NCT03220022 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Ann Arbor Stage II Diffuse Large B-Cell Lymphoma appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03220022 reports 19 study locations spanning 11 distinct geographic areas — top geographies include New York, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03220022 about?
NCT03220022 is a clinical study titled "Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas". This phase I trial studies the side effect and best dose of ibrutinib in combination with rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride in treating patients with human immunodeficiency virus (HIV)-positive stage II-IV diffuse large B-cell lymp...
What is the current status of trial NCT03220022?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 46 participants. The study started on 2018-03-16. Estimated completion is 2026-07-16.
What conditions does trial NCT03220022 study?
This clinical trial studies the following conditions: Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma, AIDS-Related Lymphoma. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03220022?
The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Filgrastim (BIOLOGICAL), Ibrutinib (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03220022?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03220022 being conducted?
This trial has 19 study locations across California, Florida, Illinois, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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