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Clinical Trials/NCT02461316
NCT02461316
Completed
Not Applicable

Open, Non-Interventional, Multicentre Trial of Rituximab in Combination With FC for the First-Line Therapy of Patients With Chronic Lymphocytic Leukaemia

Hoffmann-La Roche0 sites22 target enrollmentStarted: July 2009Last updated:
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ConditionsLymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Cancer

Overview

Phase
Not Applicable
Status
Completed
Enrollment
22
Primary Endpoint
Percentage of Adverse Events (AEs)
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Evaluation of safety profile and tolerability of MabThera (rituximab) in combination with chemotherapy (fludarabine and cyclophosphamide) in the treatment of Chronic Lymphocytic Leukemia (CLL).

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients older than 18 years with diagnosed Chronic Lymphocytic Leukemia (CLL)
  • •CLL stages: Binet stage C (Rai III or IV), Binet stage B (Rai I and II) requiring treatment

Exclusion Criteria

  • •Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)

Outcomes

Primary Outcomes

Percentage of Adverse Events (AEs)

Time Frame: From baseline to end of study up to 18 months

Percentage of Serious Adverse Events (SAEs)

Time Frame: From baseline to end of study up to 18 months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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