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NCT01886872 · ClinicalTrials.gov registry record · Phase 3

Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

A Phase 3 study of Stage I Chronic Lymphocytic Leukemia and Stage II Chronic Lymphocytic Leukemia, sponsored by National Cancer Institute (NCI).

Active
Registry status
Phase 3
Development phase
547
Enrollment target
20
Study locations

NCT01886872 is a Phase 3 study of Stage I Chronic Lymphocytic Leukemia and Stage II Chronic Lymphocytic Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 547 participants, above the 41-participant average among 3 other Stage I Chronic Lymphocytic Leukemia trials with a reported enrollment target (1234% higher). The trial reports 20 study locations across 5 states.

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The verdict

NCT01886872, a Phase 3 study of Stage I Chronic Lymphocytic Leukemia and Stage II Chronic Lymphocytic Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).

ACTIVE NOT RECRUITING
Registry status
Phase 3
Development phase
547 participants
Enrollment target
20
Study locations

Study Summary

This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Chemotherapy drugs, such as bendamustine 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. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether rituximab with bendamustine hydrochloride may work better than rituximab and ibrutinib or ibrutinib alone in treating chronic lymphocytic leukemia.

Conditions Studied

Stage I Chronic Lymphocytic Leukemia Stage II Chronic Lymphocytic Leukemia Stage IV Chronic Lymphocytic Leukemia Stage III Chronic Lymphocytic Leukemia

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Bone Marrow Biopsy
  • PROCEDURE Computed Tomography
  • DRUG Bendamustine Hydrochloride

Study Locations (20)

Alaska

  • Anchorage Radiation Therapy Center - Anchorage
  • Alaska Breast Care and Surgery LLC - Anchorage
  • Alaska Oncology and Hematology LLC - Anchorage
  • Alaska Regional Hospital - Anchorage
  • Alaska Women's Cancer Care - Anchorage
  • Anchorage Oncology Centre - Anchorage
  • Katmai Oncology Group - Anchorage
  • Providence Alaska Medical Center - Anchorage

Arizona

  • Mayo Clinic Hospital in Arizona - Phoenix
  • Mayo Clinic in Arizona - Scottsdale
  • Banner University Medical Center - Tucson - Tucson
  • University of Arizona Cancer Center-North Campus - Tucson
  • Onvida Health Yuma Medical Center - Yuma

California

  • Kaiser Permanente-Anaheim - Anaheim
  • Kaiser Permanente-Deer Valley Medical Center - Antioch
  • PCR Oncology - Arroyo Grande
  • Sutter Auburn Faith Hospital - Auburn

Arkansas

  • CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
  • NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro - Jonesboro

Alabama

  • University of Alabama at Birmingham Cancer Center - Birmingham

Trial Details

FieldValue
Enrollment Target 547 participants
Start Date 2014-01-15
Est. Completion 2026-06-07
Phase Phase 3

Sponsor

National Cancer Institute (NCI)

3,257 total trials

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What the Registry Record Tells You About NCT01886872

The ClinicalTrials.gov registry entry for NCT01886872 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 547 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 41-participant average among 3 other Stage I Chronic Lymphocytic Leukemia trials with a reported enrollment target (1234% higher). 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 Stage I Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT01886872 reports 20 study locations spanning 5 distinct geographic areas - top geographies include Alaska, Arizona, California.

Frequently Asked Questions

What is clinical trial NCT01886872 about?

NCT01886872 is a clinical study titled "Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia". This randomized phase III trial studies rituximab with bendamustine hydrochloride or ibrutinib to see how well they work compared to ibrutinib alone in treating older patients with previously untreated chronic lymphocytic leukemia. Rituximab is a monoclonal antibody that may interfere with the abili...

What is the current status of trial NCT01886872?

This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 547 participants. The study started on 2014-01-15. Estimated completion is 2026-06-07.

What conditions does trial NCT01886872 study?

This clinical trial studies the following conditions: Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia.

What interventions are being tested in trial NCT01886872?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Bendamustine Hydrochloride (DRUG).

Who is sponsoring clinical trial NCT01886872?

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

Where is trial NCT01886872 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.