An Observational Study Examining the Effect of Added MabThera Therapy in Patients With Untreated Chronic Lymphocytic Leukemia
- Conditions
- Chronic Lymphocytic Leukemia
- Registration Number
- NCT02080884
- Lead Sponsor
- Hoffmann-La Roche
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 150
- Diagnosed with first-line CLL having received only 1 cycle of MabThera chemotherapy
- aged >/= 18 years
- Pregnant or breast-feeding
- Receipt of an investigational drug within 30 days prior to entering the study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) as assessed by the investigator using routine assessment techniques 7 months
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (15)
Semmelweis University, First Dept of Medicine
🇭🇺Budapest, Hungary
National Institute of Oncology, A Dept of Internal Medicine
🇭🇺Budapest, Hungary
Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
🇭🇺Budapest, Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum; III. Belgyogyaszati Klinika
🇭🇺Debrecen, Hungary
Markhot Ferenc Oktato Korhaz es Rendelointezet; III. belgyogyaszat
🇭🇺Eger, Hungary
Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza; I. Belgyogyaszat-Hematologia Reszle
🇭🇺Gyula, Hungary
Miskolci Semmelweis Kórház és Egyetemi Oktatókórház; Haematology Dept.
🇭🇺Miskolc, Hungary
Josa Andras Korhaz; Ii. Sz. Belgyogyaszati Es Haematologiai Osztaly
🇭🇺Nyíregyháza, Hungary
University of Pecs, I st Dept of Internal Medicine
🇭🇺Pecs, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
🇭🇺Szeged, Hungary
Scroll for more (5 remaining)Semmelweis University, First Dept of Medicine🇭🇺Budapest, Hungary