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A phase II pilot trial to evaluate the efficacy of treatment with Pegilate G-CSF in a group of elderly patients AML without chemotherapy indications - ND

Conditions
acute mieloid leukemia
MedDRA version: 9.1Level: LLTClassification code 10000880Term: Acute myeloid leukaemia
Registration Number
EUCTR2006-006541-14-IT
Lead Sponsor
AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

new diagnosis of AML and: -age>80y -age>70y and AML with worse outcome
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

Exclusion Criteria

blast cells>20x10^9/L

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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