NCT05583071 Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL
| NCT ID | NCT05583071 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Cologne |
| Condition | Non-Hodgkin Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-08-23 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2024-08-23 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in patients ineligible for HCT-ASCT with Primary Central Nervous System Lymphoma (PCNSL)
Eligibility Criteria
Inclusion Criteria: 1. Age 18-69 years with ECOG PS ≥2 or age ≥70 years, and ineligible for HCT-ASCT as per investigators discretion 2. 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 3. At least one measurable lesion 4. Adequate organ function: * Adequate kidney function, defined as: * Serum creatinine estimated glomerular filtration rate (MDRD) ≥ 50 ml/min * Adequate hepatic function, defined as: * ALAT and ASAT ≤ 3 ULN * Bilirubin ≤ 2.0 mg/dl (except for Meulengracht disease) * 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 * Adequate cardiac function, defined as: * Cardiac ejection fraction ≥ 40% * Adequate pulmonary function as per investigators discretion 5. Written, signed, and dated informed consent for the trial provided by the participant 6. 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. 7. 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. Exclusion Criteria: 1. 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 2. Systemic lymphoma manifestation outside the CNS 3. Diagnosis of previous Non-Hodgkin lymphoma at any time 4. Primary vitreoretinal or leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord 5. HIV infection of any stage as determined by presence of anti-HIV antibodies (confirmatory test) and / or presence of RNA confirmed by PCR 6. 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 7. Hypersensitivity to study treatment or any component of the formulation 8. Stomatitis or gastrointestinal ulcerations preventing the use of methotrexate 9. Hepatitis B, hepatitis C or hepatitis E infection as determined by PCR 10. Severe active infection 11. Congenital or acquired immunodeficiency including previous organ transplantation 12. Pregnant or nursing (lactating) women. 13. Lack of accountability and inability to appreciate the nature, meaning and consequences of the trial and to formulate their own wishes correspondingly 14. Non-compliance, for reasons including, but not limited to the following: 1. Increased alcohol consumption, drug dependency or substance abuse that would interfere with cooperation with requirements of the trial 2. Refusal of blood products during treatment 3. Any similar circumstances that appear to make protocol treatment or long-term follow-up impossible 15. Relationship of dependence or employer-employee relationship to the sponsor or the investigator
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05583071 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Non-Hodgkin Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05583071 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05583071 currently recruiting?
Yes, NCT05583071 is actively recruiting participants. Contact the research team at MTR2-Studienteam@uk-koeln.de for enrollment information.
Where is the NCT05583071 trial being conducted?
This trial is being conducted at Stuttgart, Germany, Freiburg im Breisgau, Germany, Cologne, Germany, Hamburg, Germany and 2 additional locations.
Who is sponsoring the NCT05583071 clinical trial?
NCT05583071 is sponsored by University of Cologne. The trial plans to enroll 20 participants.