Active not recruitingPHASE3INTERVENTIONAL

OptiMATe: De-escalated Induction Treatment in Primary CNS Lymphoma

This study, called OptiMATe, is for people newly diagnosed with Primary Central Nervous System Lymphoma (PCNSL), a type of cancer that starts in the brain or spinal cord. We're testing a new treatment that's not quite as intense as the usual treatment. It involves fewer doses of a strong chemotherapy combination called MATRix. Researchers want to find out if this new, gentler approach can keep the cancer away for as long, or even longer, than the standard treatment. The goal is to see if we can get good results with less treatment, which might mean fewer side effects for patients. People aged 18 to 70 can take part if they meet certain health requirements.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Klinikum Stuttgart

Enrolment target

331

Start

28 Jun 2021

Estimated completion

01 Nov 2028

Primary Central Nervous System Lymphoma

What is this study about?

This study, named OptiMATe, is for individuals who have recently been diagnosed with Primary Central Nervous System Lymphoma, often shortened to PCNSL. This is a specific type of cancer that begins in the brain or spinal cord, rather than elsewhere in the body.

The main idea behind this research is to see if we can find a kinder way to treat this cancer. Currently, a common and effective treatment involves several cycles of a strong chemotherapy plan called MATRix. In this study, we are comparing that standard treatment with a new approach that uses a bit less of the intensive MATRix chemotherapy. Specifically, one group will receive a combination of Rituximab and High-Dose Methotrexate, followed by two cycles of MATRix, while another group will receive four cycles of MATRix, as is standard.

The main goal of comparing these two treatment plans is to find out if the less intensive treatment can keep the cancer from returning for as long, or even longer, than the standard, more intensive treatment. If the gentler treatment works just as well, or better, it could mean that patients might experience fewer side effects and have a better overall quality of life during and after their treatment.

Key takeaways

OptiMATe studies a new, potentially gentler treatment for PCNSL.
It compares a less intense treatment to the standard, stronger one.
The goal is to see if less treatment can be just as effective.
This could mean fewer side effects for patients.
Participation involves being randomly assigned to a treatment group.
Adults aged 18-70 with newly diagnosed PCNSL may be eligible.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old who has been newly diagnosed with a specific type of lymphoma called Primary Central Nervous System Lymphoma (PCNSL). This means the cancer must only be in your brain and/or spinal cord, and not elsewhere in your body. We'll need a clear diagnosis from a biopsy or other tests, and the doctors must be able to see and measure the cancer.

You also need to be generally well enough to take part. This includes having healthy kidney, liver, heart, and bone marrow function. You shouldn't have conditions that affect your immune system, like HIV, or active Hepatitis B or C. We can't include people who have had other cancers recently, or a previous diagnosis of Non-Hodgkin lymphoma.

Finally, you'll need to understand what the study involves and be willing to give your informed consent. If you're a woman, you'll need a negative pregnancy test before starting. The medical team will check all these points carefully to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Have you recently been diagnosed with Primary CNS Lymphoma, and is it only in your brain or spinal cord?
Do you not have other serious health problems like HIV or severe kidney issues?
Have you *not* had any other cancers or other forms of Non-Hodgkin lymphoma in the past?
Are you able to understand the study and willing to give your consent?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of two treatment groups, like flipping a coin. Both groups will receive cancer treatments and then have a stem cell transplant, which helps your body recover from the strong chemotherapy. The difference is in the amount of chemotherapy you receive before the transplant.

One group will have an initial treatment with Rituximab and high-dose Methotrexate, followed by two courses of the MATRix treatment. The other group will receive four courses of the MATRix treatment. Throughout the study, you'll have regular hospital visits for your treatments, blood tests, and scans to check how you're responding and to monitor for any side effects. The study team will explain the full schedule of visits and tests based on the treatment plan you receive. The total duration of active treatment and follow-up will be explained by your doctor.

Potential risks and benefits

Participating in this study might offer you access to a new treatment approach that could be gentler while still being effective against your cancer. However, as with all medical treatments, there are potential risks, including side effects from the chemotherapy and other medications. These side effects can vary from person to person and will be carefully monitored by the study team. You will be given a full explanation of all known potential side effects. It’s important to remember that joining a study is always your choice, and you are free to withdraw at any time without affecting your usual medical care.

Locations (1)

Klinikum Stuttgart
Verified postcode
Stuttgart, Germany

Common questions

What is Primary CNS Lymphoma?

It's a type of cancer that starts specifically in the brain, spinal cord, or eyes, rather than spreading from another part of the body.

What does 'de-escalated treatment' mean?

It means using a less intense or shorter course of treatment, hoping to achieve the same good results with fewer side effects.

What is MATRix treatment?

MATRix is a combination of powerful anti-cancer medicines commonly used to treat this type of lymphoma.

Will I know which treatment I'm getting?

Because this is a comparison study, you will be randomly assigned to one of the two treatment groups. Your doctors will explain which treatment you are receiving.

Who is funding this study?

Information about the specific funding body for this trial wasn't provided in the brief summary. You can ask the study team for this detail.