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Phase III, Open-Label, Randomized, Multicenter Efficacy and Safety Study of Bendamustine Hydrochloride Versus Chlorambucil in Treatment-Nave Patients with (Binet Stage B/C) B-CLL Requiring Therapy

Phase III, Open-Label, Randomized, Multicenter Efficacy and Safety Study of Bendamustine Hydrochloride Versus Chlorambucil in Treatment-Nave Patients with (Binet Stage B/C) B-CLL Requiring Therapy

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-000860-28-IT
Enrollment
Unknown
Registered
2005-03-16
Start date
2004-10-22
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

B-cell type chronic lymphocytic leukemia (B-CLL) MedDRA version: 6.1 Level: PT Classification code 10008958

Interventions

Trade Name: RIBOMUSTIN Pharmaceutical Form: Solution for infusion INN or Proposed INN: Bendamustine hydrochloride Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80

Sponsors

RIBOSEPHARM
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) yes 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