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NCT02626455 · ClinicalTrials.gov registry record · Phase 3
Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
A Phase 3 study, sponsored by Bayer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 551
- Enrollment target
NCT02626455: Clinical Trial Phase 3 study, sponsored by Bayer.
NCT02626455 is a Phase 3 study that was terminated before completion, run by Bayer. The registered enrollment target is 551 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02626455, a Phase 3 study, was terminated before completion, sponsored by Bayer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 551 participants
- Enrollment target
Study Summary
The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine \[R-B\] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone \[R-CHOP\]) is effective and safe, compared with placebo in combination with standard immunochemotherapy (R-B or R-CHOP) in patients with relapsed iNHL who have received at least one, but at most three, lines of treatment, including rituximab-based immunochemotherapy and alkylating agents.
Primary Outcome
Dose-limiting toxicity is defined as any of the following occurring during Cycle 1 at a given dose level and regarded by the investigator and/or the sponsor to be possibly, probably, or definitely related to copanlisib given in combination with R-B or R-CHOP. General: any grade 5 hematologic or non-hematologic toxicity or any delay of \>2 weeks of Cycle 2 due to study treatment-related toxicity; Non-hematologic DLT: any non-hematologic toxicity grade ≥ 3; Hematologic DLT: grade 4 absolute neutro
Interventions
- DRUG Cyclophosphamide
- DRUG Placebo
- DRUG Doxorubicin
- DRUG Rituximab
- DRUG Copanlisib (BAY80-6946)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 551 participants |
| Start Date | 2016-01-06 |
| Est. Completion | 2023-11-10 |
| Phase | Phase 3 |
Why NCT02626455 stopped before completion
NCT02626455 is an interventional study that assigns participants to a tested intervention. The registered 551 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02626455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02626455 about?
NCT02626455 is a clinical study titled "Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)". The purpose of this study is to assess whether copanlisib in combination with standard immunochemotherapy (rituximab in combination with bendamustine \[R-B\] and rituximab in combination with a 4 drug combination of cyclophosphamide, doxorubicin, vincristine and prednisone/prednisolone \[R-CHOP\]) i...
What is the current status of trial NCT02626455?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 551 participants. The study started on 2016-01-06. Estimated completion is 2023-11-10.
What interventions are being tested in trial NCT02626455?
The interventions under investigation include: Cyclophosphamide (DRUG), Placebo (DRUG), Doxorubicin (DRUG), Rituximab (DRUG), Copanlisib (BAY80-6946) (DRUG).
Who is sponsoring clinical trial NCT02626455?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02626455's enrollment target sits among peer trials
551 680th of 2000 higher than 1,321 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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