A PHASE II PROSPECTIVE STUDY OF HIGH-DOSE myeloablative therapy, WITH STEM CELL DEVICES SUPPORT IN ELDERLY PATIENTS (from 65 to 76 years) with relapsed aggressive non-Hodgkin lymphoma OR RESISTANT TO first line THERAPY.

A PHASE II PROSPECTIVE STUDY OF HIGH-DOSE myeloablative therapy, WITH STEM CELL DEVICES SUPPORT IN ELDERLY PATIENTS (from 65 to 76 years) with relapsed aggressive non-Hodgkin lymphoma OR RESISTANT TO first line THERAPY. - FIL_RecAnz

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003256-20-IT

Enrollment

115

Registered

2013-09-25

Start date

2015-07-07

Completion date

Unknown

Last updated

2024-12-16

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

Conditions

Non Hodgkin Lymphoma MedDRA version: 16.0 Level: PT Classification code 10025310 Term: Lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Desametasone Pharmaceutical Form: Solution for injection Trade Name: Cis-Platino Product Name: cis-Platino Pharmaceutical Form: Concentrate for solution for infusion Trade Name: Citarab

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of NHL - relapse and refractory pts - age 65 to 75 - ECOG PS 40 ml/min/24 h - bilirubine 50% - PA O2 >70 mmHg - no other neoplastic desease - Life expectancy> 3 months - signed informed consense Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 115

Exclusion criteria

Exclusion criteria: HBV+ - HCV+ - HIV+ - SNC involvement - meullar infiltration > 20% - other chemotherapy or radiotherapy - cardiac desease - alteration of liver and kidney function - infections -demented patient - no compliance and depressed pts - Frai and Unfit pts

Design outcomes

Primary

Measure	Time frame
Main Objective: Toxicity and high dose therapeutic approach evaluation with PBSC infusion in relapse and refractory patients with age between 65 to 75 ;Secondary Objective: Adverse events incidence evaluation (GR III or IV), RC rate and survival ;Primary end point(s): PFS for 3 years Mortality to 100 days ;Timepoint(s) of evaluation of this end point: 3 years for PFS and 100 days for mortality	—

Secondary

Measure	Time frame
Secondary end point(s): CR rate - OS -AE - QoL -Immunologic evaluation;Timepoint(s) of evaluation of this end point: at the end of therapy	—

Countries

Italy

Contacts

Public ContactAlessandro Levis

Fondazione Italiana Linfomi

segreteria@filinf.it00390131206066

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026