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Study of Copanlisib with Rituximab and CHOP for Untreated Diffuse Large B-Cell Lymphoma in Patients Aged 18-80

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL). The study is testing a new treatment combination for patients who have not been treated for this disease before. The treatment includes a medication with the code name BAY 80-6946, also known as copanlisib dihydrochloride, which is used alongside other medications: rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone. These medications are given together in a regimen known as R-CHOP chemotherapy.

The purpose of the study is to evaluate the safety and effectiveness of this treatment combination. The study will observe how patients respond to the treatment over a period of time, specifically looking at how long patients remain free from disease progression. The treatment is administered through intravenous use, meaning it is given directly into a vein. The study will last for a maximum of 18 months, during which patients will receive regular doses of the medications.

Participants in the study will be monitored closely to assess any side effects and to determine the best dose of the new medication, copanlisib, when used with the R-CHOP regimen. The study aims to provide valuable information on the potential benefits and risks of this treatment combination for patients with DLBCL.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical history, and current health status.
Informed consent is required before any study-specific procedures begin.
Step 2
Treatment initiation
The treatment involves a combination of medications administered intravenously. These include cyclophosphamide, copanlisib dihydrochloride, doxorubicin hydrochloride, rituximab, vincristine, and prednisone.
The treatment is part of a regimen known as COPA-R-CHOP, specifically designed for patients with diffuse large B-cell lymphoma (DLBCL).
Step 3
Treatment cycles
The treatment is administered in cycles. Each cycle includes the administration of the medications mentioned.
The primary objective during the first cycle is to monitor for any dose-limiting toxicity, which refers to side effects that prevent an increase in dose.
Step 4
Monitoring and assessment
Throughout the study, regular assessments are conducted to monitor the patient's response to the treatment and any side effects.
The primary efficacy objective is to estimate the progression-free survival (PFS) over two years, which measures the length of time during and after treatment that the patient lives without the disease worsening.
Step 5
Completion of study
The study is estimated to conclude by May 2025.
Upon completion, data from the study will be analyzed to determine the effectiveness and safety of the treatment regimen.

Who can join the trial?

17 criteria

Must have a confirmed diagnosis of **Diffuse large B-cell lymphoma (DLBCL)** or certain types of high-grade B-cell lymphoma.
Must have a **glomerular filtration rate (GFR)** of at least 40 mL/min/1.73 m². This measures how well the kidneys are working.
**INR** and **PTT** must be 1.5 times the upper limit of normal or less. These are tests that check how well your blood clots.
Must have a **platelet count** of at least 75,000 per mm³. Platelets help with blood clotting.
Must have a **hemoglobin** level of at least 8 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
Must have an **absolute neutrophil count** of at least 1,500 per mm³. Neutrophils are a type of white blood cell important for fighting infections.
Must have a **left ventricular ejection fraction** of at least 50%. This measures how well the heart pumps blood.
Must not have had any previous treatment for lymphoma.
Must be able to understand and willing to sign a written informed consent form before any study-specific procedures.
Must be between 18 and 80 years old.
Must have an **International Prognostic Index (IPI)** score between 2 and 5. This index helps predict the outcome of lymphoma treatment.
Must have an **ECOG performance status** of 0 to 2. This is a scale that measures how well a patient can perform daily activities.
Must have a life expectancy of at least 3 months.
Women who can have children and men must agree to use effective birth control if sexually active.
Must have a **total bilirubin** level of 1.5 times the upper limit of normal or less, with some exceptions for certain conditions. Bilirubin is a substance made during the breakdown of red blood cells.
**ALT** and **AST** levels must be 2.5 times the upper limit of normal or less, with some exceptions for liver involvement. These are liver enzymes that help assess liver function.
Must have a **lipase** level of 1.5 times the upper limit of normal or less. Lipase is an enzyme that helps digest fats.

Who cannot join the trial?

10 criteria

Patients who have a different type of cancer other than Diffuse large B-cell lymphoma (DLBCL).
Patients who are younger than 18 years old or older than 80 years old.
Patients who have a health condition that makes it unsafe to receive the study treatment.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients who have a history of severe allergic reactions to the study medications.
Patients who have an active infection that requires treatment.
Patients who have a serious heart condition.
Patients who have uncontrolled high blood pressure.
Patients who have a history of another type of cancer within the last 5 years, except for certain skin cancers or cervical cancer that has been treated.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Verified
Ulm, Germany
Kath. St. Paulus GmbH
Verified
Dortmund, Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Responsive
Stuttgart, Germany

Trial locations

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Investigated drugs

Copanlisib
is a medication used in this trial to treat patients with diffuse large B-cell lymphoma (DLBCL). It works by blocking certain proteins that help cancer cells grow, which may slow down or stop the progression of the disease. In this study, copanlisib is combined with other treatments to evaluate its effectiveness and safety.
Rituximab
is a type of medication known as a monoclonal antibody. It targets specific proteins on the surface of cancer cells, helping the immune system to recognize and destroy these cells. In this trial, rituximab is used in combination with other therapies to treat DLBCL.
CHOP Chemotherapy
is a combination of four different chemotherapy drugs used to treat lymphoma. These drugs work together to kill cancer cells or stop them from growing. CHOP includes cyclophosphamide, doxorubicin, vincristine, and prednisone. In this study, CHOP is used alongside other treatments to assess its effectiveness in treating DLBCL.

What is already known about the treatment

Copanlisib – This medication is administered intravenously and is currently being studied in combination with rituximab and CHOP chemotherapy for the treatment of diffuse large B-cell lymphoma (DLBCL). It is in the clinical trial phase, with ongoing research to determine its safety and effectiveness. Copanlisib is primarily indicated for use in patients with previously untreated DLBCL. It works by inhibiting certain enzymes involved in cell growth, specifically targeting the PI3K pathway, which is crucial for cancer cell survival and proliferation. Copanlisib is classified as a PI3K inhibitor, a type of targeted cancer therapy.

Investigated diseases

Diffuse large B-cell lymphoma (DLBCL) – This is a type of non-Hodgkin lymphoma that originates in the B-cells, which are a type of white blood cell. It is characterized by rapidly growing tumors in the lymph nodes, spleen, liver, or other organs. DLBCL can occur in any part of the body and often presents with symptoms such as swollen lymph nodes, fever, night sweats, and weight loss. The disease progresses quickly, requiring prompt medical attention. It is the most common form of non-Hodgkin lymphoma in adults. The progression and symptoms can vary significantly among individuals.