An Observational Study of MabThera/Rituxan (Rituximab) in Patients With Relapsing or Refractory Chronic Lymphocytic Leukemia

Completed

• Conditions: Lymphocytic Leukemia, Chronic

• Registration Number: NCT01488162
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This multi-center, prospective, observational study will describe the management of relapsing or refractory chronic lymphocytic leukemia (CLL) patients. Data will be collected for 2 years.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-04
• Study First Submitted: 2011-11-04
• Study First Submitted QC: 2011-12-06
• Study First Posted: 2011-12-08
• Primary Completion: 2016-10-24
• Study Completion: 2016-10-24
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-21
• Last Update Posted: 2017-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 327

Inclusion Criteria

• Adult patients, >/=18 years of age
• Diagnosis of relapsed or refractory chronic lymphocytic leukemia (CLL) with first or second relapse
• Previous treatment with MabThera/Rituxan
• MabThera/Rituxan treatment planned for current relapse

Exclusion Criteria

• Richter syndrome
• Life expectancy <6 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chemotherapy regimens associated with MabThera/Rituxan in management of relapse/refractory CLL: Percentage of patients receiving purine analogues/bendamustine/alkylating agents/other chemotherapy	2 years

Secondary Outcome Measures

Name	Time	Method
Safety (incidence of adverse events)	2 years
Overall survival	2 years
Safety (incidence of infections)	2 years
Safety (incidence of secondary malignancies)	2 years
Time to next treatment	2 years
Overall response rate	2 years
Complete response rate	2 years
Progression-free survival	2 years
Safety (incidence of hematologic adverse events)	2 years