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.
- Conditions
- on Hodgkin LymphomaMedDRA version: 16.0Level: PTClassification code 10025310Term: LymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
- Registration Number
- EUCTR2013-003256-20-IT
- Lead Sponsor
- Fondazione Italiana Linfomi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 115
Diagnosis of NHL - relapse and refractory pts - age 65 to 75 - ECOG PS <2 - FIT patients (IADL=8, ADL=6, CIRS =0 SCORE=3-4, <3 SCORE=2 ) - evaluable desease - no RT since 3 week - ANC ?1500/mm3 and platelets?100.000/106L - Creatinin ?1.5 mg/dL and clearance >40 ml/min/24 h - bilirubine < ?2 mg/dL - FEV >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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>Mortality to 100 days ;Timepoint(s) of evaluation of this end point: 3 years for PFS and 100 days for mortality
- Secondary Outcome Measures
Name Time Method Secondary end point(s): CR rate - OS -AE - QoL -Immunologic evaluation;Timepoint(s) of evaluation of this end point: at the end of therapy