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

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02080884
• Other study ID #: ML29201
• Status: Completed
• Phase: N/A
• First received: March 5, 2014
• Last updated: May 30, 2017
• Start date: June 24, 2014
• Est. completion date: December 19, 2016

Study information

• Verified date: May 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 19, 2016
• Est. primary completion date: December 19, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Locations

Country	Name	City	State
Hungary	National Institute of Oncology, A Dept of Internal Medicine	Budapest
Hungary	Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika	Budapest
Hungary	Semmelweis University, First Dept of Medicine	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	Fejér Megyei Szent György Kórház; Hematologiai Osztaly	Székesfehérvár
Hungary	Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály	Szolnok
Hungary	Vas Megyei Markusovszky Korhaz; Haematologiai Osztaly	Szombathely
Hungary	Szent Borbala Korhaz	Tatabanuya
Hungary	Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.	Veszprem

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate (ORR) as assessed by the investigator using routine assessment techniques		7 months
Secondary	ORR analysed according to concomitant chemotherapy		7 months
Secondary	ORR analysed according to age		7 months
Secondary	ORR analysed according to CIRS score		7 months
Secondary	ORR analysed according to certain chromosomal abnormalities		7 months