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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02461316

Enrollment

Registered

2015-06-03

Start date

2009-07-31

Completion date

2011-12-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphocytic Leukemia, Chronic, Chronic Lymphocytic Leukemia, Cancer

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).

Interventions

OTHERNo intervention

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

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
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

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026