Non-Hodgkin LymphomaPhase 2MTR²NCT05583071
Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL
A Phase 2 study testing Tafasitamab, Lenalidomide and Rituximab in people with Non-Hodgkin Lymphoma, run by University of Cologne at 6 sites in Germany.
Trial summary
Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in patients ineligible for HCT-ASCT with Primary Central Nervous System Lymphoma (PCNSL) Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Non-Hodgkin Lymphoma
- What is being tested?
- Tafasitamab, Lenalidomide and Rituximab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 6 sitesGermany
- Study dates
- 23 Aug 2024to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-69 years with ECOG PS ≥2 or age ≥70 years, and ineligible for HCT-ASCT as per investigators discretion
- 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
- At least one measurable lesion
- Adequate organ function:
- 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)
- 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
- Written, signed, and dated informed consent for the trial provided by the participant
- 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.
- 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.
Who cannot join
- 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
- Systemic lymphoma manifestation outside the CNS
- Diagnosis of previous Non-Hodgkin lymphoma at any time
- Primary vitreoretinal or leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord
- HIV infection of any stage as determined by presence of anti-HIV antibodies (confirmatory test) and / or presence of RNA confirmed by PCR
- Previous or concurrent malignancies with the following exceptions:
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- Surgically cured carcinoma in-situ
- Other kinds of cancer without evidence of disease for at least 5 years
- Hypersensitivity to study treatment or any component of the formulation
- Stomatitis or gastrointestinal ulcerations preventing the use of methotrexate
- Hepatitis B, hepatitis C or hepatitis E infection as determined by PCR
- Severe active infection
- Congenital or acquired immunodeficiency including previous organ transplantation
- Pregnant or nursing (lactating) women.
- Lack of accountability and inability to appreciate the nature, meaning and consequences of the trial and to formulate their own wishes correspondingly
- 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
- Relationship of dependence or employer-employee relationship to the sponsor or the investigator
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Germany6 sites, 6 recruiting
- Not yet recruiting
Charité - Universitätsmedizin Berlin
Berlin, State of Berlin, 12203
Stefan Habringer, Dr., stefan.habringer@charite.de
Björn Chapuy, Prof. Dr., +49030450 ext. 613423, bioern.chapuy@charite.de
- Not yet recruiting
University of Cologne
Cologne, Germany, 50937
Peter Borchmann, Prof. Dr. med., +49 221 478 ext. 88180, MTR2-Studientean@uk-koeln.de
Jan Michel Heger, Dr. med., +49221478 ext. 39221, MTR2-Studientean@uk-koeln.de
- Not yet recruiting
Universitätsklinikum Essen
Essen, Nordrhein Westphalen, 45147
Bastian Tresckow, PD Dr. med., +49201723 ext. 2421, bastian.tresckow@uk-essen.de
Karl Richard Maria Noppeney, Dr. med., +49201723 ext. 6120
- Not yet recruiting
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Würtemberg, 79106
Elisabeth Schorb, PD Dr. med., +49761270 ext. 35360, elisabeth.schorb@uniklinik-freiburg.de
Eliza Lauer, Dr. med., eliza.lauer@uniklinik-freiburg.de
- Not yet recruiting
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Hamurg, 20246
Minna Voigtländer, Dr. med., +49407410 ext. 0, m.voigtlaender@uke.de
Winfried Alsdorf, Dr. med.
- Recruiting
Klinikum Stuttgart - Katharienenhospital
Stuttgart, Baden-Wurttemberg, 70174
Gerald Illerhaus, Prof. Dr., +49711278 ext. 30456, g.illerhaus@klinikum-stuttgart.de
Claudia Fest, Dr., c.fest@klinikum-stuttgart.de
About this study
Official title: Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in Patients Ineligible for HCT-ASCT With Primary Central Nervous System Lymphoma (PCNSL)
Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in patients ineligible for HCT-ASCT with Primary Central Nervous System Lymphoma (PCNSL)
Read the detailed description
This is a single-arm, prospective, multicenter, single-stage phase-II trial for patients aged 18-69 years with ECOG PS ≥2 or ≥70 years with previously untreated PCNSL, who are not eligible for HCT-ASCT at investigators decision. This trial evaluates the CRR rate after at least 2 cycles of MTR2, the incidence and severity of adverse events, progression-free survival, and overall survival after one year.
It is planned to enroll eligible patients with PCNSL, i.e. who receive at least 2 cycles of the combination of rituximab, MTX and the IMPs tafasitamab and lenalidomide, over a one-year period. Follow-up will be conducted for 1 year within the trial.
- Conditions
- Non-Hodgkin Lymphoma
- Being tested
- Tafasitamab, Lenalidomide, Rituximab, Methotrexate
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafasitamabDrug
IV
LenalidomideDrug
Oral
RituximabDrug
IV
MethotrexateDrug
IV
| Study group | Role | What they receive |
|---|---|---|
| combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate | Experimental | All patients will receive tafasitamab (Minjuvi®) 12 mg/KG body weight and rituximab 375 mg/m² on days 0 and 5, followed by methotrexate 3,5 g/m² on day 1 as an intravenous infusion. Lenalidomide will be administered orally at 20 mg/day during the first cycle and at 25 mg/day during subsequent cycles on days 4-17 of each 21-day cycle for a total number of 4 cycles. The treatment duration per patient will be 84 days. Receives: Drug: Tafasitamab; Drug: Lenalidomide; Drug: Rituximab; Drug: Methotrexate |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete response rate (CRR)
The CRR will be determined by IRC and according to IPCG criteria. This endpoint reflects the proportion of patients who can potentially proceed to different consolidation or maintenance strategies to achieve durable responses.
Measured: At the end of cycle 2 (each cycle is 21 days)
Secondary outcomes (4)
Best overall response rate (BORR)
is defined as the rate of patients having achieved a CR or PR according to at least one post-baseline tumor assessment
Measured: At the end of cycle 4 (each cycle is 21 days)
Progression-free survival (PFS)
will be calculated for each patient as time between the start of treatment with MTR2 and the date of first progression, relapse or death or, in cases of continuing response, the date of the last documented follow-up (FU-CRF or written medical report).
Measured: After 1 year
Overall survival (OS)
will be calculated for each patient as time between the start of treatment with MTR2 and the date of death or the date of the last documented follow-up (FU-CRF or written medical report).
Measured: After 1 year
Incidence and severity of adverse events
Incidence and severity of adverse events, including toxic deaths during induction therapy will be summarized based on CTCAE grades
Measured: during induction therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start23 Aug 2024
- Primary completionFeb 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-arm, prospective, multicenter, single-stage phase-II trial
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Principal investigator, Prof. Dr. Peter Borchmann, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583071
- Sponsor's protocol ID
- Uni-Köln-4968
- Acronym
- MTR²
- Status last verified
- Apr 2025
- First submitted
- 2 Aug 2022
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in Patients Ineligible for HCT-ASCT With Primary Central Nervous System Lymphoma (PCNSL)
- ClinicalTrials.gov ID
- NCT05583071
- Acronym / sponsor ID
- MTR² / Uni-Köln-4968
- Conditions
- Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 23 Aug 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in patients ineligible for HCT-ASCT with Primary Central Nervous System Lymphoma (PCNSL)
Detailed description
This is a single-arm, prospective, multicenter, single-stage phase-II trial for patients aged 18-69 years with ECOG PS ≥2 or ≥70 years with previously untreated PCNSL, who are not eligible for HCT-ASCT at investigators decision. This trial evaluates the CRR rate after at least 2 cycles of MTR2, the incidence and severity of adverse events, progression-free survival, and overall survival after one year.
It is planned to enroll eligible patients with PCNSL, i.e. who receive at least 2 cycles of the combination of rituximab, MTX and the IMPs tafasitamab and lenalidomide, over a one-year period. Follow-up will be conducted for 1 year within the trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-arm, prospective, multicenter, single-stage phase-II trial
| Arm | Type | Receives |
|---|---|---|
| combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate | Experimental | Drug: Tafasitamab, Drug: Lenalidomide, Drug: Rituximab, Drug: MethotrexateAll patients will receive tafasitamab (Minjuvi®) 12 mg/KG body weight and rituximab 375 mg/m² on days 0 and 5, followed by methotrexate 3,5 g/m² on day 1 as an intravenous infusion. Lenalidomide will be administered orally at 20 mg/day during the first cycle and at 25 mg/day during subsequent cycles on days 4-17 of each 21-day cycle for a total number of 4 cycles. The treatment duration per patient will be 84 days. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18-69 years with ECOG PS ≥2 or age ≥70 years, and ineligible for HCT-ASCT as per investigators discretion
- 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
- At least one measurable lesion
- Adequate organ function:
- Written, signed, and dated informed consent for the trial provided by the participant
Key exclusion criteria (20 listed)
- 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
- Systemic lymphoma manifestation outside the CNS
- Diagnosis of previous Non-Hodgkin lymphoma at any time
- Primary vitreoretinal or leptomeningeal lymphoma without manifestation in the brain parenchyma or spinal cord
- HIV infection of any stage as determined by presence of anti-HIV antibodies (confirmatory test) and / or presence of RNA confirmed by PCR
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TafasitamabIV | Drug | combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate |
| LenalidomideOral | Drug | combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate |
| RituximabIV | Drug | combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate |
| MethotrexateIV | Drug | combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate |
Primary outcome
complete response rate (CRR)
Time frame: At the end of cycle 2 (each cycle is 21 days)
The CRR will be determined by IRC and according to IPCG criteria. This endpoint reflects the proportion of patients who can potentially proceed to different consolidation or maintenance strategies to achieve durable responses.
4 secondary outcomes
Best overall response rate (BORR)
Time frame: At the end of cycle 4 (each cycle is 21 days)
Progression-free survival (PFS)
Time frame: After 1 year
Overall survival (OS)
Time frame: After 1 year
Incidence and severity of adverse events
Time frame: during induction therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tafasitamab, Lenalidomide and Rituximab in people with Non-Hodgkin Lymphoma, run by University of Cologne at 6 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Peter Borchmann, Prof. Dr. med. (+49221478 ext. 88180, MTR2-Studienteam@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete response rate (CRR) (time frame: At the end of cycle 2 (each cycle is 21 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.