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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

Must not have

Histologically confirmed diagnosis of follicular lymphoma grade 3b or transformed disease, or chronic lymphocytic leukemia

Known lymphomatous involvement of the central nervous system

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

Pivotal 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with a specific type of lymphoma or chronic leukemia.

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My lymphoma has spread to my brain or spinal cord.

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I have been diagnosed with HIV.

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I have hepatitis B or C.

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I have been treated with copanlisib before.

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I have a lung condition or severe breathing problems.

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I have a CMV infection.

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.