Overview

This trial is active, not recruiting.

Condition chronic lymphocytic leukemia
Sponsor Hoffmann-La Roche
Start date June 2014
End date November 2016
Trial size 150 participants
Trial identifier NCT02080884, ML29201

Summary

This study will examine the effectiveness of MabThera therapy added to a standard chemotherapy regimen for the treatment of previously untreated chronic lymphocytic leukemia (CLL). Patients who have received a single prior MabThera plus chemotherapy treatment are eligible. The overall response rate of patients treated for approximately 5 months (as per current label guidelines) will be analysed according to various factors (i.e., age, concurrent treatment, and chromosomal abnormalities).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm

Primary Outcomes

Measure
Overall response rate (ORR) as assessed by the investigator using routine assessment techniques
time frame: 7 months

Secondary Outcomes

Measure
ORR analysed according to concomitant chemotherapy
time frame: 7 months
ORR analysed according to age
time frame: 7 months
ORR analysed according to CIRS score
time frame: 7 months
ORR analysed according to certain chromosomal abnormalities
time frame: 7 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosed with first-line CLL having received only 1 cycle of MabThera chemotherapy - aged >/= 18 years Exclusion Criteria: - Pregnant or breast-feeding - Receipt of an investigational drug within 30 days prior to entering the study

Additional Information

Official title A MULTICENTER NON-INTERVENTIONAL STUDY EVALUATING THE BENEFIT OF THE COMBINATION OF MABTHERA (RITUXIMAB) WITH STANDARD CHEMOTHERAPEUTIC REGIMENS IN PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN HUNGARY
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Hoffmann-La Roche.