Actively Recruiting
Adjusted High-dose Chemotherapy With Autologous Stem Cell Transplant vs. Conventional Immunochemotherapy in Elderly PCNSL Patients
Led by University Hospital Freiburg · Updated on 2025-02-17
340
Participants Needed
35
Research Sites
420 weeks
Total Duration
On this page
Sponsors
U
University Hospital Freiburg
Lead Sponsor
G
German Federal Ministry of Education and Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
Most patients being diagnosed with primary diffuse large B-cell lymphoma of the central nervous system (PCNSL) are 60 years or older. Elderly patients with PCNSL have a poor prognosis and there is a great medical need to improve outcome for this vulnerable population. In Germany and many international centres, there are currently two widely used strategies to treat elderly PCNSL patients who are eligible for high-dose methotrexate (HD-MTX) treatment, which have not yet been compared head-to-head. The R-MP regimen has been established by the Cooperative PCNSL Study Group as a "conventional" immunochemotherapy standard treatment for elderly patients with newly diagnosed disease and consists of Rituximab, HD-MTX and Procarbazine followed by maintenance therapy with Procarbazine. In contrast, another recently established protocol also includes HD-MTX-based induction therapy, but followed by consolidating high-dose chemotherapy and autologous stem cell transplantation (HCT-ASCT). This is an overall more intensive, but substantially shorter treatment approach, feasible for elderly patients being considered eligible for a more intensive treatment. The PRIMA-CNS trial aims to compare these two treatment approaches with respect to survival, response rates and toxicity.
CONDITIONS
Official Title
Adjusted High-dose Chemotherapy With Autologous Stem Cell Transplant vs. Conventional Immunochemotherapy in Elderly PCNSL Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Immunocompetent patients with newly diagnosed primary diffuse large B-cell lymphoma of the central nervous system.
- Age over 70 years, or age 65 to 70 years if not eligible for more intensive treatment.
- Diagnosis confirmed by histology or cytology by a local pathologist.
- Diagnostic sample obtained by biopsy, cerebrospinal fluid examination, or vitrectomy.
- Disease limited exclusively to the central nervous system.
- At least one measurable lesion present.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less; higher scores accepted if due to PCNSL symptoms.
- Patients considered potentially eligible for high-dose chemotherapy and autologous stem cell transplantation as judged by the treating physician.
- Written informed consent obtained from the patient or legal representative if patient is temporarily not competent.
- No evidence of disease progression after pre-phase treatment.
- Eligibility for transplant defined by specific clinical criteria (EBL score) and physician judgement.
You will not qualify if you...
- Congenital or acquired immune deficiency including HIV infection and previous organ transplantation.
- Lymphoma affecting other parts of the body outside the central nervous system.
- Primary vitreoretinal or leptomeningeal lymphoma without brain or spinal cord involvement.
- Previous or concurrent cancers except surgically cured carcinoma in situ or cancer-free for at least 5 years.
- Previous systemic Non-Hodgkin lymphoma.
- Poor kidney function (creatinine clearance less than 60 ml/min).
- Inadequate bone marrow, heart, lung, or liver function as determined by the investigator.
- Active hepatitis B or C infection.
- Current participation in other clinical trials with study drugs or recent (within 30 days) experimental treatments.
- Fluid buildup in body cavities exceeding 500 ml.
- Allergic reaction to study treatment or its components.
- Use of medications that may interact with study drugs.
- Known or ongoing substance abuse.
- Active COVID-19 infection or failure to follow COVID-19 safety measures.
- Lack of legal capacity or inability to understand the study without a legal representative.
- Previous participation in this trial.
- Employment or dependency relationship with the trial sponsor or investigator.
- Conditions that may prevent following the study protocol or follow-up schedule.
- Fertile patients unwilling to use safe contraception during the study.
AI-Screening
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Trial Site Locations
Total: 35 locations
1
University Hospital Freiburg, Department Medicine I, Hematology, oncology and stem cell transplantation
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
2
Klinikum Stuttgart, Clinic of Hematology, Oncology and Palliative Care, Stuttgart Cancer Center / Tumor Center Eva Mayr-Stihl
Stuttgart, Baden-Wurttemberg, Germany, 70174
Actively Recruiting
3
University Hospital Aachen
Aachen, Germany
Actively Recruiting
4
University Hospital Augsburg
Augsburg, Germany
Actively Recruiting
5
Helios Klinikum Berlin-Buch
Berlin, Germany
Not Yet Recruiting
6
University Hospital Berlin
Berlin, Germany
Actively Recruiting
7
Evangelisches Klinikum Bethel
Bielefeld, Germany
Not Yet Recruiting
8
Universitätsklinikum Knappschaftskrankenhaus Bochum GmbH
Bochum, Germany
Actively Recruiting
9
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany
Actively Recruiting
10
Klinikum Bremen-Mitte gGmbH
Bremen, Germany
Actively Recruiting
11
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Not Yet Recruiting
12
Universitätsklinikum Köln
Cologne, Germany
Not Yet Recruiting
13
Carl Gustav Carus Universitätsklinikum Dresden
Dresden, Germany
Actively Recruiting
14
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Not Yet Recruiting
15
Universitätsklinikum Erlangen
Erlangen, Germany
Actively Recruiting
16
Universitätsklinikum Essen
Essen, Germany
Not Yet Recruiting
17
Klinikum der Johann-Wolfgang-Goethe-Universität
Frankfurt, Germany
Actively Recruiting
18
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, Germany
Not Yet Recruiting
19
Universitätsklinikum Halle (Saale)
Halle, Germany
Not Yet Recruiting
20
Universitätsklinikum des Saarlandes Homburg
Homburg, Germany
Actively Recruiting
21
Städtisches Klinikum Karlsruhe
Karlsruhe, Germany
Actively Recruiting
22
Universitätsklinkum Schleswig-Holstein, Campus Kiel
Kiel, Germany
Actively Recruiting
23
Gemeinschaftsklinikum Mittelrhein gGmbH - Koblenz Ev. Stift St. Martin
Koblenz, Germany
Actively Recruiting
24
Universitätsklinikum Leipzig
Leipzig, Germany
Not Yet Recruiting
25
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Germany
Actively Recruiting
26
Klinikum rechts der Isar TU München
München, Germany
Not Yet Recruiting
27
Universitätsklinikum Münster
Münster, Germany
Actively Recruiting
28
Universitätsklinik der Paracelsus Medizinischen Privatuniversität
Nuremberg, Germany
Not Yet Recruiting
29
Pius-Hospital Oldenburg
Oldenburg, Germany
Actively Recruiting
30
Klinikum Oldenburg gGmbh
Oldenburg in Holstein, Germany
Not Yet Recruiting
31
Universitätsklinikum Regensburg
Regensburg, Germany
Actively Recruiting
32
Universitätsmedizin Rostock
Rostock, Germany
Not Yet Recruiting
33
Universtitätsklinikum Tübingen
Tübingen, Germany
Not Yet Recruiting
34
Universitätsklinikum Ulm
Ulm, Germany
Actively Recruiting
35
Schwarzwald-Baar-Klinikum Villingen-Schwenningen
Villingen-Schwenningen, Germany
Actively Recruiting
Research Team
E
Elisabeth Schorb, MD
CONTACT
G
Gerald Illerhaus, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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