Actively Recruiting
Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL
Led by University of Cologne · Updated on 2025-08-13
20
Participants Needed
6
Research Sites
135 weeks
Total Duration
On this page
Sponsors
U
University of Cologne
Lead Sponsor
I
Incyte Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in patients ineligible for HCT-ASCT with Primary Central Nervous System Lymphoma (PCNSL)
CONDITIONS
Official Title
Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL
Who Can Participate
Eligibility Criteria
You may qualify if you...
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Age 18-69 years with ECOG PS ≥2 or age ≥70 years, and ineligible for HCT-ASCT as per investigators discretion
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Previously untreated, histologically (or cytologically) confirmed diagnosis of primary B-cell lymphoma of the central nervous system (PCNSL) by local pathologist. Diagnostic sample obtained by stereotactic or surgical biopsy, CSF cytology examination or vitrectomy
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At least one measurable lesion
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Adequate organ function:
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Adequate kidney function, defined as:
- Serum creatinine estimated glomerular filtration rate (MDRD) ≥ 50 ml/min
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Adequate hepatic function, defined as:
- ALAT and ASAT ≤ 3 ULN
- Bilirubin ≤ 2.0 mg/dl (except for Meulengracht disease)
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Adequate bone marrow function, defined as:
- White blood cell (WBC) count ≥ 3000/µL or absolute neutrophil count (ANC) ≥ 1000/µL
- Platelets ≥ 50.000/µL
- Hemoglobin > 8.0 g/dl
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Adequate cardiac function, defined as:
- Cardiac ejection fraction ≥ 40%
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Adequate pulmonary function as per investigators discretion
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Written, signed, and dated informed consent for the trial provided by the participant
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Female persons are eligible to participate if they are post-menopausal or females of no childbearing potential or if they agree to use a method of contraception considered safe described in Section 12.1.2.1.
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Male persons with female partners of childbearing potential are eligible to participate if they agree to contraceptive methods as described in Section 12.1.2.2.
You will not qualify if you...
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Prior treatment for PCNSL with the exception of a pre-phase treatment comprising steroid treatment and / or single application of rituximab 375 mg/m² and methotrexate 3.5 g/m²
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Systemic lymphoma manifestation outside the CNS
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Diagnosis of previous Non-Hodgkin lymphoma at any time
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Primary vitreoretinal or leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord
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HIV infection of any stage as determined by presence of anti-HIV antibodies (confirmatory test) and / or presence of RNA confirmed by PCR
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Previous or concurrent malignancies with the following exceptions:
- Surgically cured carcinoma in-situ
- Other kinds of cancer without evidence of disease for at least 5 years
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Hypersensitivity to study treatment or any component of the formulation
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Stomatitis or gastrointestinal ulcerations preventing the use of methotrexate
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Hepatitis B, hepatitis C or hepatitis E infection as determined by PCR
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Severe active infection
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Congenital or acquired immunodeficiency including previous organ transplantation
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Pregnant or nursing (lactating) women.
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Lack of accountability and inability to appreciate the nature, meaning and consequences of the trial and to formulate their own wishes correspondingly
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Non-compliance, for reasons including, but not limited to the following:
- Increased alcohol consumption, drug dependency or substance abuse that would interfere with cooperation with requirements of the trial
- Refusal of blood products during treatment
- Any similar circumstances that appear to make protocol treatment or long-term follow-up impossible
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Relationship of dependence or employer-employee relationship to the sponsor or the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Klinikum Stuttgart - Katharienenhospital
Stuttgart, Baden-Wurttemberg, Germany, 70174
Actively Recruiting
2
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Würtemberg, Germany, 79106
Not Yet Recruiting
3
University of Cologne
Cologne, Germany, Germany, 50937
Not Yet Recruiting
4
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Hamurg, Germany, 20246
Not Yet Recruiting
5
Universitätsklinikum Essen
Essen, Nordrhein Westphalen, Germany, 45147
Not Yet Recruiting
6
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, Germany, 12203
Not Yet Recruiting
Research Team
P
Peter Borchmann, Prof. Dr. med.
CONTACT
J
Jan Michel Heger, Dr. med.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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