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Clinical Trials/NCT02080884
NCT02080884
Completed
Not Applicable

A MULTICENTER NON-INTERVENTIONAL STUDY EVALUATING THE BENEFIT OF THE COMBINATION OF MABTHERA (RITUXIMAB) WITH STANDARD CHEMOTHERAPEUTIC REGIMENS IN PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN HUNGARY

Hoffmann-La Roche15 sites in 1 country150 target enrollmentStarted: June 24, 2014Last updated:
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ConditionsChronic Lymphocytic Leukemia

Overview

Phase
Not Applicable
Status
Completed
Enrollment
150
Locations
15
Primary Endpoint
Overall response rate (ORR) as assessed by the investigator using routine assessment techniques
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This study will examine the effectiveness of MabThera therapy added to a standard chemotherapy regimen for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Patients who have received a single prior MabThera plus chemotherapy treatment are eligible. The overall response rate of patients treated for approximately 5 months (as per current label guidelines) will be analysed according to various factors (i.e., age, concurrent treatment, and chromosomal abnormalities).

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

  • •Diagnosed with first-line CLL having received only 1 cycle of MabThera chemotherapy
  • •aged \>/= 18 years

Exclusion Criteria

  • •Pregnant or breast-feeding
  • •Receipt of an investigational drug within 30 days prior to entering the study

Outcomes

Primary Outcomes

Overall response rate (ORR) as assessed by the investigator using routine assessment techniques

Time Frame: 7 months

Secondary Outcomes

  • ORR analysed according to concomitant chemotherapy(7 months)
  • ORR analysed according to age(7 months)
  • ORR analysed according to CIRS score(7 months)
  • ORR analysed according to certain chromosomal abnormalities(7 months)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (15)

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