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Trial Title:
Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL
NCT ID:
NCT05583071
Condition:
Non-Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Rituximab
Methotrexate
Lenalidomide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
single-arm, prospective, multicenter, single-stage phase-II trial
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tafasitamab
Description:
IV
Arm group label:
combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Oral
Arm group label:
combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate
Intervention type:
Drug
Intervention name:
Rituximab
Description:
IV
Arm group label:
combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate
Intervention type:
Drug
Intervention name:
Methotrexate
Description:
IV
Arm group label:
combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate
Summary:
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.
Criteria for 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) ≥ 60 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.
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
Gender:
All
Minimum age:
18 Years
Maximum age:
99 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Cologne
Address:
City:
Cologne
Zip:
50937
Country:
Germany
Contact:
Last name:
Peter Borchmann, Prof. Dr. med.
Phone:
+49 221 478
Phone ext:
88180
Email:
MTR2-Studientean@uk-koeln.de
Contact backup:
Last name:
Jan Michel Heger, Dr. med.
Phone:
+49221478
Phone ext:
39221
Email:
MTR2-Studientean@uk-koeln.de
Start date:
May 2024
Completion date:
April 2027
Lead sponsor:
Agency:
University of Cologne
Agency class:
Other
Collaborator:
Agency:
Incyte Corporation
Agency class:
Industry
Source:
University of Cologne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05583071
