Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia
Open, Non-Interventional, Multicentre Trial of Rituximab in Combination With FC for the First-Line Therapy of Patients With Chronic Lymphocytic Leukaemia
1 other identifier
observational
22
1 country
3
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2009
Typical duration for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
June 1, 2015
CompletedFirst Posted
Study publicly available on registry
June 3, 2015
CompletedNovember 2, 2016
November 1, 2016
2.4 years
June 1, 2015
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Adverse Events (AEs)
From baseline to end of study up to 18 months
Percentage of Serious Adverse Events (SAEs)
From baseline to end of study up to 18 months
Study Arms (1)
Combination Treatment in Chronic Lymphocytic Leukemia (CLL)
All participants receiving combination treatment in Chronic Lymphocytic Leukemia (CLL)
Interventions
No intervention administered in this study: Rituximab in combination with fludarabine and cyclophosphamide for 6 months according to registered indication.
Eligibility Criteria
Previously untreated patients with Chronic Lymphocytic Leukemia (CLL)
You may qualify if:
- 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
You may not qualify if:
- \- Patients who are not eligible for rituximab treatment according to Summary of Product Characteristics (SmPC)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Unknown Facility
Belgrade, 11000, Serbia
Unknown Facility
Kragujevac, 34000, Serbia
Unknown Facility
Novi Sad, 21000, Serbia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2015
First Posted
June 3, 2015
Study Start
July 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
November 2, 2016
Record last verified: 2016-11