Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-23

Study Completion Date

2027-04-30

Brief Summary

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

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Detailed Description

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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

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Non-Hodgkin Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

single-arm, prospective, multicenter, single-stage phase-II trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and Methotrexate

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.

Group Type EXPERIMENTAL

Tafasitamab

Intervention Type DRUG

IV

Lenalidomide

Intervention Type DRUG

Oral

Rituximab

Intervention Type DRUG

IV

Methotrexate

Intervention Type DRUG

IV

Interventions

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Tafasitamab

IV

Intervention Type DRUG

Lenalidomide

Oral

Intervention Type DRUG

Rituximab

IV

Intervention Type DRUG

Methotrexate

IV

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Prof. Dr. Peter Borchmann

Trial Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Klinikum Stuttgart - Katharienenhospital

Stuttgart, Baden-Wurttemberg, Germany

Site Status RECRUITING