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RCHOP Chemoimmunotherapy Preceded BY BBB Permeabilization by t-NGR Necrosis Factor

NCT03536039 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2022-08-03

No results posted yet for this study

Summary

Patients with primary central nervous system lymphoma (PCNSL) are treated with high-dose-methotrexate-based chemotherapy, which requires hospitalization and extensive expertise to manage related toxicity. Treatment with R-CHOP, the most commonly used combination against aggressive lymphomas, could overcome these difficulties, but CNS bioavailability of related drugs is poor due to their limited capability to cross the blood-brain barrier (BBB). Tumor necrosis factor (TNF) induces selective BBB permeabilization and enhances CNS access of anticancer drugs in animal models. The addition of NGR peptide improves biological properties of TNF, resulting in increased drug availability and antitumor synergistic effect, without increased toxicity. Thus, the addition of NGR-hTNF to R-CHOP may result in improved CNS drug availability and activity in patients with relapsed/refractory PCNSL; this hypothesis is being tested in this ongoing phase II trial called "INGRID". This trial will consider HIV-negative patients (age 18-80 ys; ECOG PS ≤3) with relapsed/refractory PCNSL previously treated with high-dose-methotrexate-based chemotherapy± radiotherapy, and with measurable disease.

Conditions

  • Lymphoma, Large B-Cell, Diffuse

Interventions

DRUG

NGR-hTNF

dose of 0.8 mcg/sqm

OTHER

RITUXIMAB

dose of 375 mg/mq

DRUG

Doxorubicin

dose of 50 mg/mq

DRUG

Cyclophosphamide

dose of 750 mg/mq

DRUG

Vincristine

dose of 1.4 mg/mq (max 2 mg)

DRUG

Prednisone

75 mg

Sponsors & Collaborators

  • AGC Biologics S.p.A.

    collaborator INDUSTRY

  • Andres J. M. Ferreri

    lead OTHER

Principal Investigators

  • Andrés Jose Maria Ferreri, MD · San raffaele hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-27
Primary Completion
2019-01-27
Completion
2020-01-27

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03536039 on ClinicalTrials.gov