Study on High-Dose Chemotherapy with Cytarabine and Drug Combination for Elderly Patients with Primary CNS Lymphoma

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What is this study about?

This clinical trial is focused on studying a rare type of cancer called Primary Central Nervous System Lymphoma (PCNSL), which affects the brain and spinal cord. This condition is most common in people aged 60 and older and often has a poor outlook. The trial aims to find the best treatment approach for elderly patients who have been newly diagnosed with this disease. The study will compare two treatment methods: one involves high-dose chemotherapy followed by a procedure called autologous stem cell transplantation (HCT-ASCT), and the other uses a more conventional chemotherapy regimen known as R-MP.

The medications being tested in this trial include CYTARABINE, PROCARBAZINE, THIOTEPA, BUSULFAN, RITUXIMAB, and METHOTREXATE DISODIUM. These drugs are used in different forms, such as solutions for infusion or capsules, and are administered either intravenously or orally. The trial will also involve a placebo group to help determine the effectiveness of the treatments. The purpose of the study is to see if the intensified chemotherapy followed by HCT-ASCT is more effective than the conventional R-MP chemotherapy in terms of how long patients live without the disease getting worse.

Participants in the study will receive one of the two treatment plans and will be monitored over time to assess their quality of life, the remission of the disease, and any side effects they may experience. The study will also look at overall survival rates and any treatment-related issues, such as neurotoxicity, which refers to damage to the nervous system. The trial is expected to continue for several years, with the goal of providing valuable information on the best treatment options for elderly patients with PCNSL.

1 initial treatment phase

The initial treatment phase involves the administration of rituximab and methotrexate disodium. These medications are given as a solution for infusion, which means they are delivered directly into the bloodstream through a vein.

This phase aims to reduce the size of the lymphoma and prepare the body for the next steps in the treatment process.

2 intensified chemotherapy

During this phase, a combination of cytarabine, procarbazine, thiotepa, and busulfan is administered. These medications are given intravenously, except for procarbazine, which is taken orally.

The purpose of this intensified chemotherapy is to further target and destroy cancer cells in the central nervous system.

3 consolidation treatment

Following the intensified chemotherapy, a high-dose chemotherapy regimen is administered. This is followed by an autologous stem cell transplantation (HCT-ASCT).

The goal of this consolidation treatment is to eliminate any remaining cancer cells and to help restore the body’s ability to produce healthy blood cells.

4 maintenance treatment

In the maintenance treatment phase, the focus is on sustaining remission and preventing the recurrence of lymphoma.

This phase may involve ongoing monitoring and additional treatments as necessary, based on the patient’s response to the previous phases.

5 follow-up and monitoring

Regular follow-up appointments are scheduled to monitor the patient’s health and to assess the effectiveness of the treatment.

During these visits, quality of life assessments and other evaluations are conducted to ensure the patient’s well-being and to detect any potential complications early.

Who Can Join the Study?

Patients must have a new diagnosis of primary diffuse large B-cell lymphoma in the central nervous system. This means the cancer is only in the brain or spinal cord.
Patients should be over 70 years old. If they are between 65 and 70 years old, they must not be eligible for more intense treatments.
The diagnosis must be confirmed by a local pathologist, which is a doctor who examines tissues to diagnose diseases.
A sample for diagnosis must be obtained through a stereotactic or surgical biopsy, CSF cytology examination, or vitrectomy. These are methods to collect tissue or fluid for testing.
The disease must be located only in the central nervous system.
There must be at least one measurable lesion, which is an area of cancer that can be measured.
The ECOG Performance Status must be 2 or less. This is a scale that measures how well a patient can perform daily activities.
Patients should be possibly eligible for HCT-ASCT, which is a type of stem cell transplant, as judged by their doctor.
Patients or their legal representatives must provide written informed consent according to international guidelines and local laws.
Patients must be eligible for HCT-ASCT based on specific criteria, including an EBL score. This score considers the patient’s ability to perform daily activities and overall health.
There should be no evidence of the disease getting worse after initial treatment.

Who Cannot Join the Study?

Patients who have a different type of lymphoma that is not the specific type being studied in this trial.
Patients who have had previous treatments that might interfere with the study’s results.
Patients who have other serious health conditions that could make it unsafe for them to participate.
Patients who are unable to follow the study procedures or attend the required visits.
Patients who are pregnant or breastfeeding, as the treatments might affect the baby.
Patients who are participating in another clinical trial at the same time.
Patients who have allergies or reactions to the medications used in the study.
Patients who have a history of certain mental health conditions that could affect their ability to participate.
Patients who have infections that are not well controlled, as this could affect their safety during the trial.
Patients who have had a recent major surgery that might affect their recovery or the study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Medizinische Universitaet Innsbruck	Innsbruck	Austria
Technische Universitaet Dresden	Dresden	Germany
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Rostock University Medical Center	Rostock	Germany

Other Sites

Site Name	City	Country
Klinikum Nuernberg	Nürnberg	Germany
Klinikum Oldenburg AöR	Oldenburg In Holstein	Germany
Pius-Hospital Oldenburg	Oldenburg In Holstein	Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)	Munich	Germany
Staedtisches Klinikum Braunschweig gGmbH	Brunswick	Germany
Staedtisches Klinikum Karlsruhe gGmbH	Karlsruhe	Germany
Barmherzige Brueder Trier gGmbH	Trier	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Gesundheit Nord gGmbH Klinikverbund Bremen	Bremen	Germany
Klinikum Bielefeld gGmbH	Bielefeld	Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH	Regensburg	Germany
HELIOS Klinikum Berlin-Buch GmbH	Berlin	Germany
Diakonie in Suedwestfalen gGmbH	Siegen	Germany
Universitaetsklinikum Regensburg AöR	Regensburg	Germany
Universitaetsklinikum Erlangen AöR	Erlangen	Germany
Klinikum Der Landeshauptstadt Stuttgart gKAöR	Stuttgart	Germany
Universitaetsklinikum Magdeburg AöR	Magdeburg	Germany
Charite Universitaetsmedizin Berlin KöR	Berlin	Germany
Evangelisches Klinikum Bethel gGmbH	Bielefeld	Germany
Klinikum Chemnitz gGmbH	Chemnitz	Germany
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse	Vienna	Austria
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH	Villingen-Schwenningen	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Universitaetsklinikum Leipzig AöR	Leipzig	Germany
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie	Homburg	Germany
Ucsquuqkxcoxxdqfviqsm Kpagruivtcthoijlzwtghfc Bmwsrk Gbqp	Bochum	Germany
Upeqaidmfx Mpkdurz Cjmvbs Hoodbjzfluhwlrpym	Hamburg	Germany
Ucyglxsvrgqzxnafyeilo Erbnu Aqm	Essen	Germany
Owmkiwwclnsxga Luub Gdeu	Linz	Austria
Mikkjnprqvinllmzkkmvkbhnit Higknsechqbrzsjy	Halle (Saale)	Germany
Ufazstbyyquxxztylzhxw Afjtzife	Augsburg	Germany
Gmxjbpijcpgfkhaqlqxyt Mbphfpbetoy gkqve	Koblenz	Germany
Utpydbvfoh Hlkkuiyg Cuanujw	Cologne	Germany
Ugqqfjqchgwiawgiyajkn Dzldijpemwz Adi	Duesseldorf	Germany
Mdgdcki Ughgakvuxr Oj Gasr	Graz	Austria
Ulkcpuefjglcjrpskgigs Mmkjztep Aag	Munster	Germany
Gpeblu Uzrrvqiqvc Fpphygbcs	Frankfurt	Germany
Kdczqxfp did Unexodxobgcl Mfhixuzh Aiu	Munich	Germany
Jysmcqii Khacrf Uoisxbycwf	Linz	Austria

Trial status

Country	Status	Recruitment Start
Austria	Recruiting	31.03.2023
Germany	Recruiting	31.03.2023

Trial locations

Investigated drugs:

High-Dose Chemotherapy is a treatment approach that uses higher than usual doses of chemotherapy drugs to kill cancer cells. In this trial, it is followed by a procedure called autologous stem cell transplantation, where a patient’s own stem cells are used to help recover the bone marrow after the high-dose chemotherapy.

Autologous Stem Cell Transplantation (HCT-ASCT) involves collecting and using a patient’s own stem cells to restore bone marrow function after intensive chemotherapy. This process helps the body recover and produce healthy blood cells more quickly.

Conventional Chemotherapy with R-MP refers to a standard chemotherapy regimen that includes a combination of drugs. R-MP typically involves the use of rituximab, a monoclonal antibody that targets specific cancer cells, along with other chemotherapy drugs to treat lymphoma.

Maintenance Therapy is a treatment given to help keep cancer from coming back after it has responded to initial therapy. In this trial, it is used following conventional chemotherapy to prolong the period of remission in patients.

Investigated diseases:

Diffuse large B-cell lymphoma

Primary Diffuse Large B-Cell Lymphoma of the Central Nervous System – This is a rare type of lymphoma that specifically affects the central nervous system, which includes the brain and spinal cord. It is characterized by the presence of large B-cells, a type of white blood cell, that grow uncontrollably within the central nervous system. The disease typically occurs in individuals who are 60 years or older. It progresses by causing neurological symptoms due to the growth of lymphoma cells in the brain or spinal cord. As the disease advances, it can lead to increased pressure within the skull and other complications related to the central nervous system. The progression of this lymphoma is often aggressive, requiring careful management to address the symptoms and impact on the nervous system.

Trial ID:

2024-512320-11-00

Protocol code:

P003077

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on High-Dose Chemotherapy with Cytarabine and Drug Combination for Elderly Patients with Primary CNS Lymphoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?