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Study on the Safety and Effectiveness of Berubicin for Patients with Central Nervous System Lymphomas

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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 the treatment of central nervous system (CNS) lymphomas, which are a type of cancer that affects the brain and spinal cord. The treatment being tested is called Berubicin hydrochloride, a medication that belongs to a group of drugs known as anthracyclines. In this study, Berubicin is given as a solution through an intravenous infusion, which means it is administered directly into the bloodstream through a vein.

The purpose of the study is to evaluate the safety and tolerability of Berubicin when used in combination with other cancer-fighting drugs, known as cytostatic agents. The study aims to determine the best dose of Berubicin for future research. Participants in the trial will receive either Berubicin or a placebo, and their health will be monitored closely to assess how well the treatment works and how it affects their body. The study will also look at how long patients live without the disease getting worse and how many patients respond positively to the treatment.

Throughout the study, researchers will collect information on the participants' health, including their response to the treatment and any side effects they experience. The trial will also involve regular check-ups and tests to monitor the participants' progress. The study is expected to continue until early 2027, with the goal of improving treatment options for patients with CNS lymphomas.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.
Laboratory tests are performed to ensure adequate bone marrow, cardiac, kidney, and liver function. These tests include blood counts and assessments of organ function.
Step 2
Treatment initiation
The treatment involves the administration of berubicin hydrochloride, a medication given as a solution for infusion through an intravenous route.
The dosage and frequency of administration are determined based on the study protocol and individual patient needs.
Step 3
Combination therapy
Berubicin is administered in combination with other cytostatic agents. The goal is to evaluate the safety and tolerability of this combination.
The recommended Phase 2 dose (RP2D) of Berubicin is determined during this phase.
Step 4
Monitoring and evaluation
Regular monitoring is conducted to assess the safety and effectiveness of the treatment. This includes physical examinations, laboratory tests, and imaging studies.
Progression Free Survival (PFS) and overall response rate (ORR) are evaluated to determine the treatment's impact on the disease.
Step 5
Follow-up
Patients are followed up for a period of up to 2 years to assess long-term outcomes such as overall survival (OS) and event-free survival (EFS).
Additional assessments may include the evaluation of complement factors, CRP protein, and circulating miRNA particles in plasma and CSF fluid.

Who can join the trial?

8 criteria

You must provide written informed consent before any study-related procedure. This means you agree to participate and understand the study is experimental.
You must be at least 18 years old.
You need a confirmed diagnosis of a type of lymphoma affecting the central nervous system (CNS). This can be confirmed by a pathologist through tests on brain tissue or other related areas.
You should not have had previous treatment with high-dose methotrexate-based chemotherapy. If you have non-Hodgkin's lymphoma, you may have had up to two courses of a specific treatment called R-CHOP if you have advanced disease.
You must not have received any investigational therapy within 4 weeks before the first dose of the study drug.
Your Eastern Cooperative Oncology Group (ECOG) Performance Status should be between 0 and 3. This is a scale that measures your ability to perform daily activities.
You must be eligible for chemotherapy based on adequate function of your bone marrow, heart, kidneys, and liver. This is determined by specific laboratory tests.
If you are a woman who can have children, you must agree to use a highly effective method of birth control starting at least 28 days before treatment and continuing until at least 3.5 months after the last dose of the study drug. Men in the study and their female partners must also agree to use effective birth control during this time.

Who cannot join the trial?

1 criterion

Patients with **central nervous system (CNS) lymphomas** cannot participate. This refers to a type of cancer that affects the brain or spinal cord.

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Pomeranian Medical University
Szczecin, Poland

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Investigated drugs

Berubicin is a medication being studied for its potential use in treating central nervous system lymphomas. It is being evaluated for its safety and how well it is tolerated when used in combination with other cancer-fighting drugs. The goal is to find the best dose to use in future studies.

Berubicin Hydrochloride

What is already known about the treatment

Berubicin – Berubicin is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied in clinical trials for its safety and effectiveness in treating central nervous system lymphomas. The main therapeutic indication for Berubicin is its potential use in combating these types of brain tumors. At the molecular level, Berubicin works by interfering with the DNA of cancer cells, preventing them from multiplying and leading to their death. It is classified pharmacologically as an anthracycline, a type of chemotherapy drug known for its ability to target and destroy cancer cells.

Investigated diseases

Central Nervous System Lymphomas – Central nervous system lymphomas are a type of cancer that originates in the lymphatic tissue of the brain or spinal cord. These lymphomas can either be primary, starting in the CNS, or secondary, spreading from other parts of the body. The disease often presents with neurological symptoms such as headaches, seizures, or changes in personality or cognition. As the lymphoma progresses, it can lead to increased intracranial pressure and further neurological deficits. The growth of these lymphomas can be aggressive, requiring careful monitoring and management.