Clinical trial NCT01609023: A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic Leukemia
Official title: A Non-Interventional, Observational Phase IV Study to Evaluate Safety of Rituximab (Mabthera®) in Combination With Chemotherapy in Patients Treated With CD20+ Β Chronic Lymphocytic Leukemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy

Brief summary: This observational study will evaluate the safety and efficacy of rituximab in combination with chemotherapy in first- and second-line treatment of participants with cluster of differentiation 20 (CD20)-positive B-cell chronic lymphocytic leukemia. Data will be collected from eligible participants receiving rituximab according to the Summary of Product Characteristics (SPC) during 6 months of treatment.


Eligibility criteria: Inclusion Criteria:

- Participants with CD20-positive B-cell chronic lymphocytic leukemia eligible for first-line or second-line therapy according to the approved SPC

Exclusion Criteria:

- Contraindications to rituximab therapy according to the approved SPC

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: Baseline up to 24 months
Secondary outcomes:
measure: Progression-Free Survival (PFS) Assessed Using Local Standards
timeFrame: From enrollment until disease progression or death, assessed up to 24 months
measure: Percentage of Participants With Disease Progression or Death Assessed Using Local Standards
timeFrame: Months 6, 12, 18, and 24
measure: Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) Assessed Using Local Standards
timeFrame: Months 6, 12, 18, and 24
measure: Percentage of Participants With CR Assessed Using Local Standards
timeFrame: Months 6, 12, 18, and 24
measure: Percentage of Participants With PR Assessed Using Local Standards
timeFrame: Months 6, 12, 18, and 24
measure: Time to Progression (TTP) Assessed Using Local Standards
timeFrame: From enrollment until disease progression or death, assessed up to 26 months
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: University General Hospital of Alexandroupolis; Haemotology
city: Athens
country: Greece
facility: General Hospital of Athens Evangelismos; Hematology
city: Athens
country: Greece
facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
city: Athens
country: Greece
facility: Metropolitan Hospital; Hematology Dept
city: Heraklion
country: Greece
facility: Periph. University General Hospital of Heraklion; Hematology
city: Larissa
country: Greece
facility: University Hospital of Larissa; Hematology Dept.
city: Patras
country: Greece
facility: University Hospital Of Patras; Dept. Of Internal Medicine-Hematology Division
city: Patra
country: Greece
facility: General Hospital of Patras Agios Andreas; Hematology Department
city: Thessaloniki
country: Greece
facility: Georgios Papanikolaou Hospital; Hematology Department
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: