ACTIVITY OF R-CHOP CHEMOIMMUNOTHERAPY BY NGR-TUMOR NECROSIS FACTOR IN PATIENTS WITH RELAPSED OR REFRACTORY PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA

MONO-INSTITUTIONAL PHASE II TRIAL ADDRESSING TOLERABILITY AND ACTIVITY OF R-CHOP CHEMOIMMUNOTHERAPY PRECEDED BY BLOOD-BRAIN BARRIER PERMEABILIZATION BY NGR-TUMOR NECROSIS FACTOR IN PATIENTS WITH RELAPSED OR REFRACTORY PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA - Ingrid

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-001532-11-IT

Enrollment

Registered

2014-07-28

Start date

2014-09-11

Completion date

Unknown

Last updated

2015-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary non-Hodgkin lymphoma in the central nervous system relapse / refractory

Interventions

Product Name: ARENEGYR Product Code: Ngr-TNF Pharmaceutical Form: Solution for injection INN or Proposed INN: non disponibile CAS Number: Not applicab Current Sponsor code: NGR-TNF Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with primary brain lymphoma in relapsed or refractory after first-line chemotherapy based on high-dose methotrexate 2. Disease exclusively confined to the central nervous system with the presence of at least one bi-dimensionally measurable lesion 3. Aged between 18 and 80 years and ECOG performance status 75000/mmc, hemoglobin> 8 g / dL, neutrophils> 1000/mmc), renal (serum creatinine = 40 mL / min), cardiac (FE> = 50%), hepatic (SGOT / SGPT =65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: 1. Chronic HIV positive or other immune deficiencies 2. Comorbidities that might prevent the deadlines set by the study (eg, severe heart disease) 3. Concomitant treatment with other antineoplastic drugs 4. Pregnant or breastfeeding. Women of childbearing potential not employing adequate contraception during study participation 5. Previous or concomitant other malignancies diagnosed or relapsed during the last 3 years, with the exception of in situ cancers treated surgically and basal cell carcinomas of the skin 6. Whatever the psychosocial, familial, sociological or geographical potentially limiting compliance to the study

Design outcomes

Primary

Measure	Time frame
Main Objective: feasibility of chemo-immunotherapy with standard R-CHOP preceded by Ngr-TNF;Secondary Objective: Tolerability, overall response, duration of response, bioavailability of drugs in the cerebrospinal fluid after permealizzazione membrane of the blood-brain with ngr-TNF, Overall Survival;Primary end point(s): feasibility of an experimental treatment consisting of R-CHOP chemoimmunotherapy preceded by Blood Brain Barrier Permeabilization (BBBP) by NGR-Tumor Necrosis Factor (NGR-hTNF);Timepoint(s) of evaluation of this end point: tolerability, drug bioavailability in CSF, overall response rate, response duration, overall survival	—

Measure

Time frame

Main Objective: feasibility of chemo-immunotherapy with standard R-CHOP preceded by Ngr-TNF;Secondary Objective: Tolerability, overall response, duration of response, bioavailability of drugs in the cerebrospinal fluid after permealizzazione membrane of the blood-brain with ngr-TNF, Overall Survival;Primary end point(s): feasibility of an experimental treatment consisting of R-CHOP chemoimmunotherapy preceded by Blood Brain Barrier Permeabilization (BBBP) by NGR-Tumor Necrosis Factor (NGR-hTNF);Timepoint(s) of evaluation of this end point: tolerability, drug bioavailability in CSF, overall response rate, response duration, overall survival

—

Secondary

Measure	Time frame
Secondary end point(s): end of treatment;Timepoint(s) of evaluation of this end point: end of treatment	—

Countries

Italy

Contacts

Public ContactLymphoid malingnancies Unit Data Ma

Ospedale San Raffaele

ferreri.andres@hsr.it+390226433919

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 17, 2026