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Study on Methotrexate, Tafasitamab, Lenalidomide, and Rituximab for Patients with Primary Central Nervous System Lymphoma Not Eligible for Stem Cell Transplant

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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 Primary Central Nervous System Lymphoma (PCNSL). This is a rare form of cancer that affects the brain and spinal cord. The study is testing a combination of treatments to see how effective they are for patients who cannot undergo certain intensive therapies. The treatments being tested include Methotrexate, Tafasitamab (also known as Minjuvi®), Lenalidomide (also known as Revlimid®), and Rituximab. These medications are used to target and treat cancer cells in different ways.

The purpose of the study is to find a treatment plan that is both practical and effective for patients with PCNSL. Participants in the study will receive these medications over a period of time, and their response to the treatment will be monitored. The study will look at how well the cancer responds to the treatment after at least two cycles, which are periods during which the medication is given. The study will also assess the overall response after four cycles, as well as the time patients remain free from cancer progression and their overall survival.

Throughout the study, the safety of the treatment will be closely monitored by checking for any side effects or adverse events. The study will also evaluate the quality of life and cognitive function of the participants using specific questionnaires. The goal is to ensure that the treatment is not only effective but also safe and manageable for patients. This trial aims to provide valuable information that could lead to better treatment options for those affected by PCNSL.

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, diagnosis, and organ function.
Informed consent is required, ensuring understanding of the trial's purpose and procedures.
Step 2
Treatment cycle 1
The first cycle of treatment begins with the administration of methotrexate through infusion. This medication is used to treat cancer by slowing or stopping the growth of cancer cells.
Following methotrexate, tafasitamab is administered via infusion. Tafasitamab is an antibody that targets specific proteins on cancer cells.
The cycle continues with lenalidomide, taken orally in capsule form. Lenalidomide helps the immune system attack cancer cells and reduces their growth.
Finally, rituximab is given through infusion. Rituximab is another antibody that targets cancer cells.
Step 3
Treatment cycle 2
The second cycle of treatment repeats the same sequence of medications: methotrexate, tafasitamab, lenalidomide, and rituximab.
The effectiveness of the treatment is assessed after this cycle, focusing on the complete response rate.
Step 4
Treatment cycle 3 and 4
Cycles three and four continue with the same regimen of methotrexate, tafasitamab, lenalidomide, and rituximab.
The best overall response rate is evaluated after these cycles, determining the extent of tumor reduction.
Step 5
Follow-up and assessment
Progression-free survival and overall survival are monitored, measuring the time until disease progression or death.
Quality of life and cognitive function are assessed using specific questionnaires.
Safety is evaluated by tracking any adverse events experienced during the trial.

Who can join the trial?

11 criteria

Must be between 18 and 69 years old with an ECOG PS of 2 or higher, or 70 years or older and not eligible for HCT-ASCT as decided by the doctor. ECOG PS is a scale to measure how well a person can perform daily activities. HCT-ASCT refers to a type of stem cell transplant.
Must have a confirmed diagnosis of primary B-cell lymphoma of the central nervous system (PCNSL) that has not been treated before. This diagnosis should be confirmed by a local pathologist using a sample obtained through specific medical procedures like a biopsy or examination of certain body fluids.
Must have at least one measurable lesion, which means a tumor or abnormal area that can be measured in size.
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Must have adequate organ function, which includes:
- Kidney function: Serum creatinine estimated glomerular filtration rate (MDRD) of 60 ml/min or higher.
- Liver function: ALAT and ASAT levels should be 3 times the upper limit of normal or lower, and bilirubin should be 2.0 mg/dl or lower (except for Meulengracht disease).
- Bone marrow function: White blood cell count of 3000/µL or higher, or absolute neutrophil count (ANC) of 1000/µL or higher; platelets of 50,000/µL or higher; hemoglobin greater than 8.0 g/dl.
- Heart function: Cardiac ejection fraction of 40% or higher.
- Lung function as determined by the doctor.
- Must provide written, signed, and dated informed consent to participate in the trial.
- Male participants with female partners who can have children must agree to use contraceptive methods as described in the trial protocol.
- Female participants are eligible if they are post-menopausal or cannot have children.

Who cannot join the trial?

2 criteria

Patients who are able to receive intensive induction and consolidation therapies. This means treatments that are very strong and given in a short period to quickly reduce cancer.
Patients who are part of a vulnerable population. This refers to groups of people who might be at higher risk of harm or exploitation, such as children or those unable to make decisions for themselves.

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Verified sites

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

Verified
Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
Responsive
Klinikum Der Landeshauptstadt Stuttgart gKAöR
Stuttgart, Germany
Verified
Medical Center - University Of Freiburg
Freiburg Im Breisgau, Germany

Trial locations

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Investigated drugs

Methotrexate
is a medication used in this trial to help treat primary central nervous system lymphoma (PCNSL). It works by slowing or stopping the growth of cancer cells.
Tafasitamab
(Minjuvi®) is an antibody therapy included in the trial. It targets specific proteins on the surface of cancer cells, helping the immune system to identify and destroy these cells.
Lenalidomide
(Revlimid®) is a medication that modifies the immune system and has anti-cancer effects. It is used in this trial to help enhance the body's ability to fight cancer.
Rituximab
is an antibody therapy that targets certain proteins on cancer cells, marking them for destruction by the immune system. It is used in this trial to help treat PCNSL by working with the body's natural defenses.

What is already known about the treatment

Methotrexate
Methotrexate is administered intravenously and is currently used in medical practice for various types of cancer, including primary central nervous system lymphoma (PCNSL). It is well-documented in medical literature as a chemotherapy agent. Methotrexate works by inhibiting the enzyme dihydrofolate reductase, which is crucial for DNA synthesis, thus preventing cancer cell growth. It is classified as an antimetabolite and antifolate drug.
Tafasitamab
Tafasitamab is given as an intravenous infusion and is approved for use in certain types of lymphoma. It is being studied for its effectiveness in treating PCNSL. Tafasitamab targets the CD19 protein on B-cells, leading to the destruction of these cancerous cells. It is classified as a monoclonal antibody.
Lenalidomide (Revlimid)
Lenalidomide is taken orally and is widely used in the treatment of multiple myeloma and certain lymphomas. It is being evaluated for its potential in treating PCNSL. Lenalidomide modulates the immune system and inhibits angiogenesis, which helps in controlling cancer growth. It belongs to the class of immunomodulatory drugs.
Rituximab
Rituximab is administered via intravenous infusion and is a well-established treatment for various types of lymphoma, including PCNSL. It works by targeting the CD20 protein on B-cells, leading to their destruction. Rituximab is classified as a monoclonal antibody and is extensively documented in medical literature.

Investigated diseases

Primary Central Nervous System Lymphoma (PCNSL) – This is a type of non-Hodgkin lymphoma that occurs in the brain, spinal cord, or eye. It originates from lymphocytes, which are a type of white blood cell, and primarily affects the central nervous system. The disease can cause symptoms such as headaches, confusion, memory problems, and changes in vision or speech, depending on the areas of the brain involved. PCNSL tends to grow and spread quickly within the central nervous system, leading to a rapid progression of symptoms. It is considered a rare form of lymphoma and is often diagnosed through imaging studies and biopsy. The progression of PCNSL can vary, but it typically requires prompt medical attention due to its aggressive nature.