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Phase II pilot trial to evaluate the efficacy and safety of a first-line combined therapeutic approach for young (> = 60 years old) CLL patients with advanced and progressive disease stratified according to the biological prognostic features. GIMEMA LLC0405. EudraCT Number 2005-002476-15.

Phase II pilot trial to evaluate the efficacy and safety of a first-line combined therapeutic approach for young (> = 60 years old) CLL patients with advanced and progressive disease stratified according to the biological prognostic features. GIMEMA LLC0405. EudraCT Number 2005-002476-15.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002476-15-IT
Enrollment
Unknown
Registered
2006-01-03
Start date
2005-07-28
Completion date
Unknown
Last updated
2013-01-07

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

Conditions

CLL patients (diagnosis of CLL according to NCI criteria) with the following characteristics: Advanced stage or progressive disease with at least 2 clinical features of activity. Previously untreated patients. Age &lt

Interventions

Trade Name: MABCAMPATH*EV 3F 3ML 10MG/ML Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Alemtuzumab Concentration unit: mg milligram(s) Concentration number: 10-

Sponsors

G.I.M.E.M.A. GRUPPO ITALIANO MALATTIE EMATOLOGICHE DELL'ADULTO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no Number of subjects for this age range: 0 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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

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