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

Other Sites

Site Name	City	Country
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie	Homburg	Germany
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH	Regensburg	Germany
Kcdtzyfc Ncgylnfva	Nürnberg	Germany
Uhshunxazl Hviehali Cpbwdzw	Cologne	Germany
Uxpqnhrwcryhrhvcklxmg Eftdbacu Alz	Erlangen	Germany
Ckdgxgy Uwyljvjikyauvdczdzau Bkcljn Kih	Berlin	Germany
Ubnjqhgzioidrdtxhrpgy Dtydnteqfsn Awb	Duesseldorf	Germany
Kihxoyhb Cmebyacb gynul	Chemnitz	Germany
Mqmjxvf Uihrhwjiby Oe Ghmx	Graz	Austria
Hgdocvl Knsycswfigz Dim Waeyfl Gzejgiatgkdntrpbthp	Vienna	Austria
Uegmuxgxsbfhmcwpyllez Mpqfkmgr Azr	Munster	Germany
Jaovbvub Kfgxju Utvsiydhjh	Linz	Austria
Mfeunvv Czmsnm &ystklg Uazxgnwmpz Oa Fyygwiqp	Freiburg Im Breisgau	Germany
Kqpivmeg dhy Udrjqzayfczm Muogyphp Afb	Munich	Germany
Kzyftgwm dis Tsyrspkmvov Urbovjakavov Mytnurrf (rcl Kgwvkgqrg	Munich	Germany
Uuldonoomw Melglvv Crqgxx Hihrdkijisecwuofl	Hamburg	Germany
Uvfdafgeqyexrtlmybpli Etuxy Afb	Essen	Germany
Ojuqptbpjxhfqm Lykj Gcvp	Linz	Austria
Ijtkmsiy fifn Krdonyjuh Tyvzhfutxaciwhnkyae uoa Iwfdexnjiqhv Uxr gjxbt	Ulm	Germany
Urcsuxdjecxcqaevpdgxp Aqynpy Avj	Aachen	Germany
Uaudxvjyvjeoeppihckha Sxrtwiuvuhkihcrbnq Ave	Kiel	Germany
Hizylf Kubtrfwr Btngqdwavoe Gtsa	Berlin	Germany
Utvjslrormbyvcizkphle Lpksjtr Avu	Leipzig	Germany
Kbysssef Oztdctaqz Alc	Oldenburg In Holstein	Germany
Pgbhdimemorzs Ooprsiyvh	Oldenburg In Holstein	Germany
Gawyfyvwsihbbpmjwsovu Msyqadzcnzk gixym	Koblenz	Germany
Umjedoueswnwxpgaidpio Kneqqyymoopwwklxmlbuqju Bkyfam Gjjr	Bochum	Germany
Uwdsdatjmcayeanxouzph Rlyxtczhul Abm	Regensburg	Germany
Kvgfmxwe Ddj Lmmmrmhjzujthxdq Scieubdwe gfhvn	Stuttgart	Germany
Udoqogxzrrribykgqowxx Mtfsnzrvo Avf	Magdeburg	Germany
Erchdkurylncq Kjyvircg Bpjsjl gkedj	Bielefeld	Germany
Gpmozz Utoeatsiug Fibujoprd	Frankfurt	Germany
Ssubgcmgenluokne Kvcxkzjp Vvdzgidmlalxurticiwfoo Gduw	Villingen-Schwenningen	Germany
Sjqvqcgohiod Kgyovqgi Bngloztgogva ghdez	Brunswick	Germany
Sccepzepcfzh Kzsmoyed Kgsrefitq gsdoy	Karlsruhe	Germany
Bnwffvekpwb Bkdhchn Tcmjp gknmk	Trier	Germany
Mmcdfxffjbeqiiwcoyueurnozn Hphvscbhtkmxegof	Halle (Saale)	Germany
Ucdnefbobtujmlookvkkl Awnavexe	Augsburg	Germany
Dhuyvnws iz Shlhspnvyrfvo gmcgq	Siegen	Germany
Ghsuojlltc Nmee geegb Kwrwbfutnwslu Binlry	Bremen	Germany
Kypjdwhg Blfmyiewb gkubc	Bielefeld	Germany

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?