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NCT03220022 · ClinicalTrials.gov registry record · Phase 1

Ibrutinib, Rituximab, Etoposide, Prednisone, Vincristine Sulfate, Cyclophosphamide, and Doxorubicin Hydrochloride in Treating Patients With HIV-Positive Stage II-IV Diffuse Large B-Cell Lymphomas

A Phase 1 study of Ann Arbor Stage II Diffuse Large B-Cell Lymphoma and Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 1
Development phase
46
Enrollment target
19
Study locations

NCT03220022 is a Phase 1 study of Ann Arbor Stage II Diffuse Large B-Cell Lymphoma and Ann Arbor Stage III Diffuse Large B-Cell Lymphoma that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 46 participants, below the 138-participant average among 3 other Ann Arbor Stage II Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (67% lower). The trial reports 19 study locations across 11 states.

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The verdict

NCT03220022, a Phase 1 study of Ann Arbor Stage II Diffuse Large B-Cell Lymphoma and Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
46 participants
Enrollment target
19
Study locations

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

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

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

FieldValue
Enrollment Target 46 participants
Start Date 2018-03-16
Est. Completion 2026-07-16
Phase Phase 1

Sponsor

National Cancer Institute (NCI)

3,257 total trials

Interested in This Trial?

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, categorized as Phase 1. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 138-participant average among 3 other Ann Arbor Stage II Diffuse Large B-Cell Lymphoma trials with a reported enrollment target (67% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.

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.

NCT03220022 reports 19 study locations spanning 11 distinct geographic areas - top geographies include New York, California, Florida.

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.

What interventions are being tested in trial NCT03220022?

The interventions under investigation include: Cyclophosphamide (DRUG), Doxorubicin Hydrochloride (DRUG), Etoposide (DRUG), Filgrastim (BIOLOGICAL), Ibrutinib (DRUG).

Who is sponsoring clinical trial NCT03220022?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

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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