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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006541-14-IT
Enrollment
Unknown
Registered
2007-08-02
Start date
2007-07-27
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

acute mieloid leukemia MedDRA version: 9.1 Level: LLT Classification code 10000880 Term: Acute myeloid leukaemia

Interventions

Trade Name: NEULASTA Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Pegfilgrastim Concentration unit: mg milligram(s) Concentration type: equal Concentration number:

Sponsors

AZIENDA OSPEDALIERA SPEDALI CIVILI DI BRESCIA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: blast cells>20x10^9/L

Design outcomes

Primary

MeasureTime frame
Main Objective: -to evaluate the hematological response on periferic blood -to evaluate the pegfilgrastim effect on treated patients'overall survival;Secondary Objective: -to evaluate the complete remission occurency -to evaluate the safety of the first-line pegfilgrastim treatment in elderly AML patients -to evaluate infections and hospitalizations occurency;Primary end point(s): -to evaluate the hematological response on periferic blood -to evaluate the pegfilgrastim effect on treated patients'overall survival—

Countries

Italy

Outcome results

None listed

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