Overview

This trial is active, not recruiting.

Condition lymphocytic leukemia, chronic
Sponsor Hoffmann-La Roche
Trial size 327 participants
Trial identifier NCT01488162, ML25664

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Non Interventional Study Aimed to Describe the Management of Relapse or Refractory Chronic Lymphocytic Leukemia (CLL) Patients Retreated by MabThera
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.