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Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL

ConditionNon-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Cologne

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Serum creatinine estimated glomerular filtration rate (MDRD) ≥ 50 ml/min

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Tafasitamab

    Drug

    IV

  • Lenalidomide

    Drug

    Oral

  • Rituximab

    Drug

    IV

  • Methotrexate

    Drug

    IV

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: combination of Tafasitamab (Minjuvi®), Lenalidomide, Rituximab and MethotrexateExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
At the end of cycle 2 (each cycle is 21 days)

Secondary outcomes

1

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

Time frame
At the end of cycle 4 (each cycle is 21 days)
2

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).

Time frame
After 1 year
3

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).

Time frame
After 1 year
4

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

Time frame
during induction therapy

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Cologne

Lead sponsor

Incyte Corporation

Collaborator

Source ClinicalTrials.gov
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