Study of Copanlisib in Combination With Standard Immunochemotherapy in Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Public ClinicalTrials.gov record NCT02626455. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III, Randomized, Double-blind, Controlled Multicenter Study of Intravenous PI3K Inhibitor Copanlisib in Combination With Standard Immunochemotherapy Versus Standard Immunochemotherapy in Patients With Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02626455
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 551 participants
Conditions and interventions
Conditions
Interventions
- Copanlisib (BAY80-6946) Drug
- Placebo Drug
- Rituximab Drug
- Cyclophosphamide Drug
- Doxorubicin Drug
- Vincristine Drug
- Bendamustine Drug
- Prednisone Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 6, 2016 (Actual)
- Primary completion
- Sep 15, 2023 (Actual)
- Completion
- Nov 10, 2023 (Actual)
- Last update posted
- Dec 11, 2024
2016 – 2023
United States locations
- U.S. sites
- 10
- U.S. states
- 7
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Ironwood Physicians P.C. DBA Ironwood Cancer & Res. Ctr. | Chandler | Arizona | 85224 | — |
| Brian J. LeBerthon, MD | West Covina | California | 91790 | — |
| SCL Health Research at St Joseph's Hospital Denver CO | Denver | Colorado | 80218 | — |
| Lewis Hall Singletary Oncology Center | Thomasville | Georgia | 31792 | — |
| Memorial Sloan Kettering Cancer Center- Bergen | New York | New York | 10021 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10065 | — |
| New York Cancer and Blood Specialists | Port Jefferson Station | New York | 11776 | — |
| Gabrail Cancer Center | Canton | Ohio | 44718 | — |
| Oncology Consultants | Houston | Texas | 77024-2645 | — |
| Texas Oncology- McAllen | McAllen | Texas | 78503 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 191 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02626455, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 11, 2024 · Synced Oct 19, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02626455 live on ClinicalTrials.gov.