Study on the Safety and Effectiveness of Glofitamab with R-CHOP for High-Risk Patients with Untreated Diffuse Large B-Cell Lymphoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called Diffuse Large B-Cell Lymphoma (DLBCL). This is a common form of non-Hodgkin lymphoma, which is a cancer that starts in white blood cells. The study is investigating a treatment that combines a new medication called Glofitamab with a standard chemotherapy regimen known as R-CHOP. R-CHOP includes a combination of drugs: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone. The purpose of the study is to evaluate how effective and safe this combination is for patients who have not yet received treatment for their DLBCL and are considered high-risk based on a specific marker in their blood called circulating tumor DNA (ctDNA).

Participants in the study will receive the treatment through an intravenous (IV) infusion, which means the medication is given directly into a vein. The study will monitor the participants over a period to see how well the cancer responds to the treatment and to check for any side effects. The goal is to see if the combination of Glofitamab and R-CHOP can improve the complete response rate, which means the cancer is no longer detectable at the end of the treatment. The study will also look at other outcomes, such as overall survival and progression-free survival, which measures how long patients live without the cancer getting worse.

This trial is important because it explores a new potential treatment option for people with high-risk DLBCL, aiming to improve their chances of recovery and manage the disease more effectively. The study will provide valuable information on the safety and effectiveness of using Glofitamab in combination with R-CHOP, potentially leading to better treatment strategies for this type of lymphoma.

1 initial assessment

The trial begins with an initial assessment to confirm eligibility. This includes a review of medical history and specific tests to ensure the patient meets the criteria for participation.

Eligibility criteria include having untreated diffuse large B-cell lymphoma, a life expectancy of at least 6 months, and adequate blood samples for biomarker analysis.

2 treatment initiation

The treatment phase starts with the administration of medications. The patient receives glofitamab and RoActemra (tocilizumab) through an intravenous (IV) infusion.

The treatment also includes a combination of medications known as R-CHOP, which consists of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone.

3 treatment cycles

The treatment is administered in cycles. Each cycle includes the IV infusion of glofitamab and RoActemra, along with the R-CHOP regimen.

The frequency and duration of each cycle are determined by the study protocol and the patient’s response to treatment.

4 monitoring and evaluation

Throughout the trial, the patient’s response to treatment is closely monitored. This includes regular medical examinations and imaging tests to assess the effectiveness of the treatment.

The primary goal is to evaluate the complete response rate at the end of treatment, as determined by specific criteria.

5 end of treatment assessment

At the end of the treatment phase, a comprehensive assessment is conducted to determine the overall response to the therapy.

This includes evaluating the patient’s health status and any changes in the condition of the lymphoma.

6 follow-up

After the treatment phase, follow-up visits are scheduled to monitor the patient’s long-term health and any potential side effects.

These visits help ensure the patient’s well-being and gather additional data on the treatment’s effectiveness.

Who Can Join the Study?

Patients must have Diffuse Large B-Cell Lymphoma (DLBCL) that has not been treated before. This includes certain types identified by the World Health Organization.
Patients should have an International Prognostic Index (IPI) score between 1 and 5. This is a way to assess the risk level of the lymphoma.
Patients need to have a life expectancy of at least 6 months.
Patients must provide adequate blood samples before starting treatment to check for circulating-tumor DNA (ctDNA) status. This is a type of DNA found in the blood that can give information about the cancer.
Patients should have at least one lymphoma lesion that can be measured using a PET/CT scan. This is a type of imaging test that helps to see the cancer.
Patients need to have a left ventricular ejection fraction (LVEF) of 50% or higher. This is a measure of how well the heart is pumping blood, checked by a heart scan.
Both male and female patients can participate.
Patients from vulnerable populations are also eligible.

Who Cannot Join the Study?

Patients who have received previous treatment for their Diffuse Large B-Cell Lymphoma (DLBCL) cannot participate. This means if you have already been treated for this type of cancer, you are not eligible.
Patients with other types of cancer that are currently being treated or have been treated recently are excluded. This means if you have another cancer that is active or was treated not long ago, you cannot join the study.
Patients with serious heart problems are not allowed to participate. This includes conditions like heart failure or recent heart attacks.
Patients with severe infections that are not controlled are excluded. This means if you have a serious infection that is not being managed well, you cannot take part.
Patients who are pregnant or breastfeeding cannot join the study. This is to ensure the safety of both the mother and the baby.
Patients with known allergies to the study drugs or their components are not eligible. If you have a history of allergic reactions to similar medications, you cannot participate.
Patients with certain blood disorders that affect normal blood cell production are excluded. This means if you have a condition that impacts how your blood cells are made, you cannot join.
Patients who have had a major surgery within a certain time frame before the study starts are not allowed to participate. This is to ensure proper recovery from surgery before joining the study.
Patients with a history of drug or alcohol abuse that could interfere with the study are excluded. This means if substance use might affect your ability to follow the study procedures, you cannot take part.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Salamanca	Salamanca	Spain
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Hospital Universitario 12 De Octubre	Madrid	Spain
Centre Henri Becquerel	Rouen	France
Hospital Clinic De Barcelona	Barcelona	Spain
Hopital Beaujon	Clichy	France
Uqzknlcnmrkl Mevqlbp Czjwzjv Grrkyjtjx	Groningen	The Netherlands
Abhzcj Ungkizzvff Hobkosxs	Aarhus	Denmark
Ucghgifuvniizb Chqtqtw Kuatacrzg	Gdansk	Poland

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	31.03.2022
France	Not recruiting	31.03.2022
Poland	Not recruiting	31.03.2022
Spain	Not recruiting	31.03.2022
The Netherlands	Not recruiting	31.03.2022

Trial locations

Investigated drugs:

Glofitamab is an investigational medication being studied for its potential to treat certain types of cancer. In this trial, it is being tested to see how well it works when combined with other cancer treatments in patients with a specific type of lymphoma.

Rituximab is a medication used to treat certain types of cancer, including lymphoma. It works by targeting specific cells in the immune system to help the body fight cancer.

Cyclophosphamide is a chemotherapy drug that helps stop the growth of cancer cells. It is often used in combination with other medications to treat various types of cancer.

Doxorubicin is a chemotherapy medication used to treat cancer by slowing or stopping the growth of cancer cells. It is commonly used in combination with other cancer treatments.

Vincristine is a chemotherapy drug that works by inhibiting the growth of cancer cells. It is often used as part of a combination therapy to treat different types of cancer.

Prednisone is a corticosteroid medication that helps reduce inflammation and suppress the immune system. It is used in cancer treatment to help manage symptoms and improve the effectiveness of other cancer therapies.

Diffuse Large B-Cell Lymphoma – 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. The disease can cause symptoms such as swelling of lymph nodes, fever, night sweats, and weight loss. It is considered an aggressive form of lymphoma due to its fast progression. The condition can affect individuals of any age but is more common in older adults. The exact cause of this lymphoma is not well understood, but it involves genetic mutations in the B-cells.

Trial ID:

2023-504994-19-00

Protocol code:

GO43075

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Glofitamab with R-CHOP for High-Risk Patients with Untreated Diffuse Large B-Cell Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?