Recruiting

Study on the Effectiveness of Rituximab and Drug Combination for Patients with High-Risk Aggressive B-Cell Lymphoma

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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 aggressive B-cell lymphoma, which is a fast-growing cancer that affects the lymphatic system, a part of the body's immune system. The trial aims to evaluate the effectiveness of a treatment regimen known as R-Hyper-CVAD/R-MA. This treatment involves a combination of several medications, including rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, methotrexate, cytarabine, etoposide, prednisolone, and dexamethasone. These medications are used to target and kill cancer cells, and they are administered in various forms such as infusions, injections, and oral tablets.

The purpose of this study is to assess how well the R-Hyper-CVAD/R-MA treatment works in patients with high-risk aggressive B-cell lymphomas. Participants in the study will receive the treatment over a period of time, with regular monitoring to track their response to the therapy. The study will also compare the outcomes of patients receiving the treatment with those who might receive a placebo. The trial will look at several outcomes, including how long patients live without the cancer getting worse, overall survival rates, and the response of the cancer to the treatment.

Throughout the study, participants will be closely monitored by healthcare professionals to ensure their safety and to manage any side effects that may occur. The trial is designed to provide valuable information about the effectiveness of the R-Hyper-CVAD/R-MA treatment regimen in managing aggressive B-cell lymphomas, potentially leading to improved treatment options for patients with this type of cancer.

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
Initial treatment phase
The treatment begins with the administration of doxorubicin hydrochloride through an intravenous infusion. This is a solution for infusion.
Following this, vincristine sulfate is given as an intravenous bolus. This means it is injected directly into the bloodstream in a single dose.
The patient will also take prednisolone orally in tablet form. This medication is taken daily.
Step 2
Combination therapy
The next phase involves a combination of medications. Cyclophosphamide is administered through an intravenous infusion.
Additionally, etoposide is given as a solution for infusion. This medication is administered over a period of time through an intravenous line.
The patient will also receive rituximab through an intravenous infusion. This is a targeted therapy that helps the immune system attack cancer cells.
Step 3
Maintenance therapy
During the maintenance phase, methotrexate is administered as an injection. This is done to help prevent the cancer from returning.
The patient will also take dexamethasone orally in tablet form. This medication helps reduce inflammation and manage side effects.
Step 4
Consolidation phase
In this phase, cytarabine is administered through an intravenous infusion. This medication is used to kill any remaining cancer cells.
The patient will continue to receive etoposide as a solution for infusion during this phase.
Step 5
Follow-up and monitoring
After completing the treatment cycles, regular follow-up appointments are scheduled to monitor the patient's health and response to the treatment.
These appointments may include physical exams, blood tests, and imaging studies to ensure the cancer has not returned and to manage any long-term side effects.

Who can join the trial?

7 criteria

You must provide written informed consent, which means you agree to participate after understanding the study details.
You need to be between 18 and 64 years old.
You should be eligible to receive at least 4 courses of the treatment called R-Hyper-CVAD/R-MA. This decision is made by the doctor based on your overall health, age, social situation, and the status of your lymphoma.
You must have a specific type of aggressive B-cell lymphoma that has not been treated before. This includes several subtypes like Diffuse large B-cell lymphoma and others listed in the study.
You need to meet at least one of the high-risk criteria defined in the study protocol.
If you are a woman who can have children, you must use an effective method of birth control during the treatment and for six months after finishing the treatment.
If you are a sexually active male, you must agree to use a condom during treatment and for six months after finishing the treatment to prevent exposing embryos or fetuses to the study drugs. Your female partner should also use a method of birth control to prevent pregnancy.

Who cannot join the trial?

5 criteria

Patients who have a different type of cancer other than lymphoma cannot participate. Lymphoma is a type of cancer that affects the immune system.
Patients who are younger than 18 years old cannot participate.
Patients who are part of a vulnerable population, such as those who cannot make decisions for themselves, cannot participate.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who have any other medical condition that might interfere with the study cannot participate.

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Karolinska University Hospital
Solna, Sweden

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Investigated drugs

Rituximab
is a medication used in this trial to help the immune system target and destroy cancer cells. It is often used in combination with other chemotherapy drugs to treat certain types of lymphoma.
Cyclophosphamide
is a chemotherapy drug that works by slowing or stopping the growth of cancer cells. It is part of the treatment regimen in this trial to help reduce the size of the lymphoma.
Vincristine
is a chemotherapy medication that interferes with the growth of cancer cells. It is used in this trial to help treat aggressive B-cell lymphomas.
Doxorubicin
is a chemotherapy drug that works by interfering with the DNA inside cancer cells, preventing them from growing and dividing. It is included in the treatment plan for this trial.
Methotrexate
is a medication that helps stop the growth of cancer cells. In this trial, it is used as part of the treatment regimen to manage high-risk aggressive B-cell lymphomas.
Cytarabine
is a chemotherapy drug that targets and kills cancer cells. It is used in this trial to help treat aggressive forms of lymphoma.

Vincristine Sulfate

What is already known about the treatment

R-Hyper-CVAD/R-MA – This medication regimen is administered intravenously and is used in the treatment of high-risk aggressive B-cell lymphomas. It is currently being evaluated in a phase II clinical trial to assess its effectiveness. The main therapeutic indication is lymphoma, specifically targeting aggressive forms. The regimen works by combining multiple chemotherapy agents that interfere with the DNA replication of cancer cells, ultimately leading to cell death. It falls under the pharmacological classification of antineoplastic agents, which are drugs used to treat cancer.

Investigated diseases

Lymphoma – Lymphoma is a type of cancer that begins in the lymphatic system, which is part of the body's immune system. It occurs when lymphocytes, a type of white blood cell, grow uncontrollably and form tumors in the lymph nodes, spleen, or other organs. There are two main types: Hodgkin lymphoma and non-Hodgkin lymphoma, each with different characteristics and progression patterns. Symptoms may include swollen lymph nodes, fever, night sweats, and weight loss. The disease can spread to other parts of the body, including the liver, bone marrow, and lungs. The progression of lymphoma varies widely depending on the type and stage at diagnosis.