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NCT02367040 · ClinicalTrials.gov registry record · Phase 3
Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)
A Phase 3 study of Lymphoma, Non-Hodgkin, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 458
- Enrollment target
- 20
- Study locations
NCT02367040: Completed Phase 3 study of Lymphoma, Non-Hodgkin, sponsored by Bayer.
NCT02367040 is a Phase 3 study of Lymphoma, Non-Hodgkin that has completed, run by Bayer. The registered enrollment target is 458 participants, above the 381-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (20% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02367040, a Phase 3 study of Lymphoma, Non-Hodgkin, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 458 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Progression-free survival (PFS) was defined as the time from randomization to progressive disease (PD) or death due to any cause, whichever was earlier according to the Lugano Classification and Response criteria in patients affected by Waldenström macroglobulinemia (kindly refer to the links in the Protocol section).
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
| Field | Value |
|---|---|
| Enrollment Target | 458 participants |
| Start Date | 2015-08-03 |
| Est. Completion | 2024-11-15 |
| Phase | Phase 3 |
What the finished NCT02367040 record still lists
NCT02367040 is an interventional study that assigns participants to a tested intervention. The registered 458 participants enrollment target is mid-sized for trials with a published cap, above the 381-participant average among 58 other Lymphoma, Non-Hodgkin trials with a reported enrollment target (20% higher).
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.
NCT02367040 names 20 study sites across 13 states, led by New Jersey, New York, Kentucky.
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.
What interventions are being tested in trial NCT02367040?
The interventions under investigation include: Placebo (DRUG), Rituximab (DRUG), Copanlisib (Aliqopa, BAY80-6946) (DRUG).
Who is sponsoring clinical trial NCT02367040?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Lymphoma, Non-Hodgkin
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02367040's enrollment target sits among peer trials
458 10th of 58 higher than 49 of 58 other Lymphoma, Non-Hodgkin trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lymphoma, Non-Hodgkin trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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