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PI3K Inhibitor

Copanlisib + Rituximab for Non-Hodgkin's Lymphoma (CHRONOS-3 Trial)

Phase 3

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically confirmed diagnosis of Indolent non-Hodgkin's lymphoma (iNHL) in CD20 positive patients with specific histological subtypes

Patients must have relapsed after the last rituximab-, rituximab biosimilars-, or anti-CD20 monoclonal antibody-containing therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from first participant randomization (20-aug-2015) up to data cut-off date at primary completion (31-aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-aug-2022, up to 7 years

Awards & highlights

CHRONOS-3 Trial Summary

This trial evaluates whether copanlisib, when combined with rituximab, is better than placebo at prolonging progression-free survival in patients with relapsed iNHL.

Who is the study for?

Adults with relapsed Indolent B-cell Non-Hodgkin's Lymphoma who've had previous treatments including rituximab. They should have a specific type of lymphoma, be unfit for chemotherapy due to age or health issues, or unwilling to receive it. Participants need good heart function and performance status, and can't join if they've had certain infections or resistance to similar drugs.Check my eligibility

What is being tested?

The trial is testing the effectiveness of copanlisib combined with rituximab versus a placebo combined with rituximab in extending the time patients live without their disease getting worse. It targets those who responded well to past treatments but now show signs of cancer returning.See study design

What are the potential side effects?

Possible side effects include high blood sugar levels, lung problems like coughing or difficulty breathing, infections due to weakened immune defenses, liver enzyme changes indicating liver stress or damage, fatigue, hypertension (high blood pressure), and nausea.

CHRONOS-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lymphoma is a type that grows slowly and tests positive for CD20.

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My condition worsened after my last treatment with a rituximab-based therapy.

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I have a measurable tumor or an enlarged spleen.

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My Waldenstrom's macroglobulinemia can be measured by tests.

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I can take care of myself and am up and about more than half of my waking hours.

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I either meet specific criteria after my last treatment or am not fit for chemotherapy.

CHRONOS-3 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from first participant randomization (20-aug-2015) up to data cut-off date at primary completion (31-aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-aug-2022, up to 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from first participant randomization (20-aug-2015) up to data cut-off date at primary completion (31-aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-aug-2022, up to 7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and from first participant randomization (20-aug-2015) up to data cut-off date at primary completion (31-aug-2020), approximately 5 years and 2-year follow-up after primary completion at 31-aug-2022, up to 7 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival (PFS) Based on Independent Central Review.

Secondary outcome measures

Complete Response Rate (CRR)

Disease Control Rate (DCR)

Duration of Response (DOR)

+7 more

Side effects data

From 2016 Phase 2 & 3 trial • 86 Patients • NCT03002038

Gastrointestinal intolerance

Impaired liver function test

100%

80%

60%

40%

20%

Study treatment Arm

Azathioprine

Rituximab

CHRONOS-3 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Copanlisib + RituximabExperimental Treatment2 Interventions

Combination of the Copanlisib and rituximab

Group II: Placebo + RituximabPlacebo Group2 Interventions

Combination of Copanlisib placebo and rituximab

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

Copanlisib (Aliqopa, BAY80-6946)

2018

Completed Phase 2

~380

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,240 Previous Clinical Trials

25,332,319 Total Patients Enrolled

Bayer Study DirectorStudy DirectorBayer

1,180 Previous Clinical Trials

4,261,481 Total Patients Enrolled

Media Library

Copanlisib (PI3K Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02367040 — Phase 3

Non-Hodgkin's Lymphoma Research Study Groups: Placebo + Rituximab, Copanlisib + Rituximab

Non-Hodgkin's Lymphoma Clinical Trial 2023: Copanlisib Highlights & Side Effects. Trial Name: NCT02367040 — Phase 3

Copanlisib (PI3K Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02367040 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Rituximab a common drug in clinical trials?

"Rituximab was first studied in 1993 at National Institutes of Health Clinical Center. To date, there have been 19031 completed studies on this medication, with 449 currently active trials. A significant portion of these studies are concentrated in the state of New jersey."

Answered by AI

Has Rituximab undergone testing by the FDA?

"There is evidence from Phase 3 clinical trials to support the efficacy of Rituximab, as well as multiple rounds of data that suggest it is a safe medication. Therefore, we have given it a score of 3."

Answered by AI

What are some of the most common illnesses that Rituximab has been known to help?

"Rituximab can be used to treat diffuse large b-cell lymphoma (dlbcl), b-cell lymphomas, and polyangium."

Answered by AI

Are new participants being enrolled in this clinical trial at this time?

"The clinical trial in question is not currently recruiting patients, as per the information available on clinicaltrials.gov. This study was initially posted on 2015-08-03, and was last updated on 2022-10-14. There are 2276 other studies that are currently accepting participants."

Answered by AI

Recent research and studies

The Lancet OncologyJournal

Copanlisib Plus Rituximab Versus Placebo Plus Rituximab in Patients with Relapsed Indolent Non-hodgkin Lymphoma (CHRONOS-3): A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial

Matasar, Matthew J, Marcelo Capra, Muhit Özcan, Fangfang Lv, Wei Li, Eduardo Yañez, Katya Sapunarova, et al.. 2021. “Copanlisib Plus Rituximab Versus Placebo Plus Rituximab in Patients with Relapsed Indolent Non-hodgkin Lymphoma (CHRONOS-3): A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00145-5.

The Lancet OncologyJournal

Copanlisib Plus Rituximab Versus Placebo Plus Rituximab in Patients with Relapsed Indolent Non-hodgkin Lymphoma (CHRONOS-3): A Double-blind, Randomised, Placebo-controlled, Phase 3 Trial

clinicaltrials.govStudy

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

2015. "Copanlisib and Rituximab in Relapsed Indolent B-cell Non-Hodgkin's Lymphoma (iNHL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02367040.

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