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COMPLETED Phase 3

Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)

NCT02367040 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who either had a treatment-free interval of ≥ 12 months after completion of the last rituximab-containing treatment, or who are unwilling to receive chemotherapy/for whom chemotherapy is contraindicated on reason of age, comorbidities, and/or residual toxicity.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Rituximab
  • DRUG Copanlisib (Aliqopa, BAY80-6946)

Study Locations (20)

New Jersey

  • — Montvale
  • MSK Basking Ridge — New Jersey
  • MSK Bergen — New Jersey
  • MSK Monmoth — New Jersey

New York

  • MSK Westchester — Harrison
  • MSK Commack — Long Island City
  • MSK Rockville Centre — Long Island City
  • — New York

Kentucky

  • — Ashland
  • — Louisville

California

  • — West Covina

Maryland

  • — Bethesda

Nevada

  • — Las Vegas

Ohio

  • — Canton

Utah

  • — Salt Lake City

Trial Details

FieldValue
Enrollment Target 458 participants
Start Date 2015-08-03
Est. Completion 2024-11-15
Phase Phase 3

Sponsor

Bayer

143 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02367040

The ClinicalTrials.gov registry entry for NCT02367040 describes a study currently listed as completed. 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 458 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Lymphoma,Non-Hodgkin appearing as the primary indexed condition, and to 3 interventions — of which Placebo 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: NCT02367040 reports 20 study locations spanning 13 distinct geographic areas — top geographies include New Jersey, New York, Kentucky. 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 NCT02367040 about?

NCT02367040 is a clinical study titled "Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)". The purpose of this study was to evaluate whether copanlisib in combination with rituximab is superior to placebo in combination with rituximab in prolonging progression free survival (PFS) in patients with relapsed iNHL who have received one or more lines of treatment, including rituximab and who e...

What is the current status of trial NCT02367040?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 458 participants. The study started on 2015-08-03. Estimated completion is 2024-11-15.

What conditions does trial NCT02367040 study?

This clinical trial studies the following conditions: Lymphoma,Non-Hodgkin. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02367040?

The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG), Copanlisib (Aliqopa, BAY80-6946) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02367040?

This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02367040 being conducted?

This trial has 20 study locations across California, Kentucky, Maryland, Nevada, New Jersey. 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