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Palifermin use in patients , out of clinical investigation, which are receiving chemioterapic therapy with staminal cells to reduce severuty and incidence of mucositis. - ND

Phase 1
Conditions
mucositis
MedDRA version: 9.1Level: LLTClassification code 10028128Term: Mucositis management
Registration Number
EUCTR2006-001923-20-IT
Lead Sponsor
OSPEDALE S. RAFFAELE
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
50
Inclusion Criteria

age 18 ;paz. with staminal cells trasplantation after mieloablative conditioning procedures; patients affected by non Hodking s linfoma,Hodcking disease, mieloid leucemia,leucemia mieloide acuta, linfoblastic acute leucemia , chronic linphatic leucemia or multiple mieloma
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

Exclusion Criteria

hospitalization and myocardial infarction 30 days before the start of the trial; inadeguate contraception;nursing.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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