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

N/ACompletedNCT02080884

Hoffmann-La Roche150 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

150

Conditions

Chronic Lymphocytic Leukemia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Semmelweis University, First Dept of Medicine

Budapest, Hungary

National Institute of Oncology, A Dept of Internal Medicine

Budapest, Hungary

Outcomes

Primary Outcomes

Overall response rate (ORR) as assessed by the investigator using routine assessment techniques

Time frame: 7 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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