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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01862445
Other study ID # LLC1013
Secondary ID
Status Active, not recruiting
Phase
First received May 17, 2013
Last updated March 21, 2018
Start date October 2013
Est. completion date May 2018

Study information

Verified date March 2018
Source Gruppo Italiano Malattie EMatologiche dell'Adulto
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a non interventional study to evaluate the efficacy and safety of Chlorambucil plus Rituximab as firstline therapy in elderly and/or unfit patients affected by B-cell Chronic Lymphocytic Leukemia (B-CLL).


Description:

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Study Design


Related Conditions & MeSH terms


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Sponsors (1)

Lead Sponsor Collaborator
Gruppo Italiano Malattie EMatologiche dell'Adulto

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of responding patients. Overall response rate. 10 months from study entry
Secondary Number of adverse events. Safety of Rituximab and Chlorambucil regimen (type, frequency and severity). 24 months from study entry
Secondary Number of days from the first dose of treatment to re-treatment. Time to Re-Treatment (TTR) estimation starting from the date of the first dose of the study drug 24 months from study entry.
Secondary Number of patients surviving. Progression Free Survival (PFS) estimation starting from the date of the first dose of the study drug.
Overall Survival (OS) estimation starting from the date of the first dose of the study drug
24 months from study entry.
Secondary Number of patients in which the response and the biological and clinical characteristics of the disease at baseline are associated. Fitness status, FISH, IgVH, Zap70 and CD38. After 10 months from study entry.
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