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Randomized study of high-dose chemotherapy plus rituximab (R-HDS) vs conventional chemotherapy with rituximab (R-FC) in chronic lymphocytic leukemia at high risk.

Randomized study of high-dose chemotherapy plus rituximab (R-HDS) vs conventional chemotherapy with rituximab (R-FC) in chronic lymphocytic leukemia at high risk.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-005384-28-IT
Enrollment
96
Registered
2005-11-11
Start date
2004-03-24
Completion date
Unknown
Last updated
2014-05-12

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

Conditions

Chronic lymphocytic leukemia at high risk MedDRA version: 6.1 Level: PT Classification code 10008943

Interventions

Product Name: rituximab Pharmaceutical Form: Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500-

Sponsors

FONDAZIONE MICHELANGELO - AVANZAMENTO DELLO STUDIO E CURA DEI TUMORI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Are the trial subjects under 18? no 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) 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