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ACTIVE NOT RECRUITING Phase 1

Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma

NCT01479842 · View on ClinicalTrials.gov ↗

Study Summary

This phase I trial studies the side effects and best dose of BTK inhibitor PCI-32765 when given together with rituximab and bendamustine hydrochloride in treating patients with recurrent non-Hodgkin lymphoma (NHL). BTK inhibitor PCI-32765 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving BTK inhibitor PCI-32765 together with rituximab and bendamustine hydrochloride may kill more cancer cells.

Interventions

  • BIOLOGICAL rituximab
  • OTHER pharmacological study
  • DRUG BTK inhibitor PCI-32765
  • DRUG bendamustine hydrochloride
  • OTHER pharmacogenomic studies

Study Locations (1)

Ohio

  • Ohio State University Medical Center — Columbus

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2014-03-26
Est. Completion 2026-09-01
Phase Phase 1

Sponsor

Kami Maddocks, MD

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01479842

The ClinicalTrials.gov registry entry for NCT01479842 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 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kami Maddocks, MD, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 10 conditions, with Waldenstrom Macroglobulinemia appearing as the primary indexed condition, and to 5 interventions — of which rituximab 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: NCT01479842 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. 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 NCT01479842 about?

NCT01479842 is a clinical study titled "Rituxan/Bendamustine/PCI-32765 in Relapsed DLBCL, MCL, or Indolent Non-Hodgkin's Lymphoma". This phase I trial studies the side effects and best dose of BTK inhibitor PCI-32765 when given together with rituximab and bendamustine hydrochloride in treating patients with recurrent non-Hodgkin lymphoma (NHL). BTK inhibitor PCI-32765 may stop the growth of cancer cells by blocking some of the e...

What is the current status of trial NCT01479842?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2014-03-26. Estimated completion is 2026-09-01.

What conditions does trial NCT01479842 study?

This clinical trial studies the following conditions: Waldenstrom Macroglobulinemia, Recurrent Mantle Cell Lymphoma, Recurrent Grade 1 Follicular Lymphoma, Recurrent Grade 2 Follicular Lymphoma, Recurrent Marginal Zone 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 NCT01479842?

The interventions under investigation include: rituximab (BIOLOGICAL), pharmacological study (OTHER), BTK inhibitor PCI-32765 (DRUG), bendamustine hydrochloride (DRUG), pharmacogenomic studies (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01479842?

This trial is sponsored by Kami Maddocks, MD, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01479842 being conducted?

This trial has 1 study location across Ohio. 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