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

Completed

• 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

Study Timeline

• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-06
• Study Start: 2014-06-24
• Primary Completion: 2016-12-19
• Study Completion: 2016-12-19
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-30
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Diagnosed with first-line CLL having received only 1 cycle of MabThera chemotherapy
• aged >/= 18 years

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Exclusion Criteria

• Pregnant or breast-feeding
• Receipt of an investigational drug within 30 days prior to entering the study

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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 Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika; 🇭🇺 Budapest, Hungary

Semmelweis University, First Dept of Medicine; 🇭🇺 Budapest, Hungary

National Institute of Oncology, A Dept of Internal Medicine; 🇭🇺 Budapest, Hungary

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum; III. Belgyogyaszati Klinika; 🇭🇺 Debrecen, Hungary

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza; I. Belgyogyaszat-Hematologia Reszle; 🇭🇺 Gyula, Hungary

Markhot Ferenc Oktato Korhaz es Rendelointezet; III. belgyogyaszat; 🇭🇺 Eger, Hungary

Miskolci Semmelweis Kórház és Egyetemi Oktatókórház; Haematology Dept.; 🇭🇺 Miskolc, Hungary

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály; 🇭🇺 Szolnok, Hungary

Josa Andras Korhaz; Ii. Sz. Belgyogyaszati Es Haematologiai Osztaly; 🇭🇺 Nyíregyháza, Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika; 🇭🇺 Szeged, Hungary

University of Pecs, I st Dept of Internal Medicine; 🇭🇺 Pecs, Hungary

Fejér Megyei Szent György Kórház; Hematologiai Osztaly; 🇭🇺 Székesfehérvár, Hungary

Vas Megyei Markusovszky Korhaz; Haematologiai Osztaly; 🇭🇺 Szombathely, Hungary

Szent Borbala Korhaz; 🇭🇺 Tatabanuya, Hungary

Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.; 🇭🇺 Veszprem, Hungary