An Observational Study Examining the Effect of Added MabThera Therapy in Patients With Untreated Chronic Lymphocytic Leukemia

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02080884

Enrollment

150

Registered

2014-03-06

Start date

2014-06-24

Completion date

2016-12-19

Last updated

2017-05-31

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

Conditions

Chronic Lymphocytic Leukemia

Brief 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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Hungary

Outcome results