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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 study about?

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.

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.

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.

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.

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.

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 Study?

  • 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.
  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Technische Universitaet Dresden Dresden Germany

Other Sites

Site Name City Country Status
Klinikum Der Landeshauptstadt Stuttgart gKAöR Stuttgart Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Uheztjdxsmowbofwyozkq Aaivtvpd Augsburg Germany
Upnlokghkx Hqgxljvn Cpqkupn Cologne Germany
Usxvrvmpeh Mpszczx Crgtrg Hmjixyycvekpzxnwz Hamburg Germany
Usytjhjseqnumounkfifb Emvjn Afd Essen Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not recruiting
01.10.2023

Trial locations

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.

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.

Trial ID:
2022-502790-42-00
Protocol code:
Uni-Koeln-4968
NCT ID:
NCT05583071
Trial Phase:
Therapeutic exploratory (Phase II)

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