RecruitingPhase 2NCT05583071

Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL

Pilot-trial of Methotrexate, Tafasitamab (Minjuvi®), Lenalidomide (Revlimid®) and Rituximab in Patients Ineligible for HCT-ASCT With Primary Central Nervous System Lymphoma (PCNSL)

Sponsor

University of Cologne

Enrollment

20 participants

Start Date

Aug 23, 2024

Study Type

INTERVENTIONAL

Conditions

Non-Hodgkin Lymphoma

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria19

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
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.

Exclusion Criteria20

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:
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