Rituximab in Combination With Fludarabine and Cyclophosphamide in Patients With Chronic Lymphocytic Leukemia

Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02461316
• Other study ID #: ML25066
• Status: Completed
• Phase: N/A
• First received: June 1, 2015
• Last updated: November 1, 2016
• Start date: July 2009
• Est. completion date: December 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia:Medicines and Medical Devices Agency of Serbia (ALIMS)
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Cancer

Intervention

Other:
• No intervention
No intervention administered in this study: Rituximab in combination with fludarabine and cyclophosphamide for 6 months according to registered indication.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Adverse Events (AEs)		From baseline to end of study up to 18 months	No
Primary	Percentage of Serious Adverse Events (SAEs)		From baseline to end of study up to 18 months	No