Combination treatment for patients with primary central nervous system lymphoma
Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in Patients Ineligible for HCT-ASCT With Primary Central Nervous System Lymphoma (PCNSL)
This study is testing a new combination of treatments for adults with primary central nervous system lymphoma who can't have high-dose chemotherapy to see if it helps them get better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Cologne Academic / other |
| Drugs / interventions | rituximab, methotrexate, Tafasitamab |
| Locations | 6 sites (Stuttgart, Baden-Wurttemberg and 5 other locations) |
| Trial ID | NCT05583071 on ClinicalTrials.gov |
What this trial studies
This pilot trial evaluates the effectiveness of a combination therapy using Methotrexate, Tafasitamab, Lenalidomide, and Rituximab in patients aged 18-69 with primary central nervous system lymphoma (PCNSL) who are not eligible for high-dose chemotherapy with autologous stem cell transplantation. The study is a single-arm, multicenter phase II trial that aims to assess the complete response rate after at least two cycles of treatment, as well as the incidence of adverse events and overall survival over one year. Eligible participants will be closely monitored for their response to the treatment and any side effects experienced during the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-69 with untreated PCNSL and an ECOG performance status of 2 or higher, or those aged 70 and older.
Not a fit: Patients with previously treated PCNSL or those who are eligible for high-dose chemotherapy with autologous stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with PCNSL who currently have limited treatment alternatives.
How similar studies have performed: While this approach is novel in the context of PCNSL, similar combination therapies have shown promise in treating other forms of lymphoma.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stuttgart, Baden-Wurttemberg and 5 other locations
- Klinikum Stuttgart - Katharienenhospital — Stuttgart, Baden-Wurttemberg, Germany (Recruiting)
- Universitätsklinikum Freiburg — Freiburg im Breisgau, Baden-Würtemberg, Germany (Not_yet_recruiting)
- University of Cologne — Cologne, Germany, Germany (Not_yet_recruiting)
- Universitätsklinikum Hamburg-Eppendorf — Hamburg, Hamurg, Germany (Not_yet_recruiting)
- Universitätsklinikum Essen — Essen, Nordrhein Westphalen, Germany (Not_yet_recruiting)
- Charité - Universitätsmedizin Berlin — Berlin, State of Berlin, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Peter Borchmann, Prof. Dr. med.
- Email: MTR2-Studienteam@uk-koeln.de
- Phone: +49221478
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.