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ACTIVE NOT RECRUITING Phase 3

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

NCT01886872 · View on ClinicalTrials.gov ↗

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.

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)

2,390 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01886872

The ClinicalTrials.gov registry entry for NCT01886872 describes a study currently listed as active not recruiting. It is categorized as Phase 3, 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 547 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 Stage I Chronic Lymphocytic Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Biospecimen Collection 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: NCT01886872 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Alaska, Arizona, California. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01886872?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial