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

NCT ID: NCT02080884

Last Updated: 2017-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-24

Study Completion Date

2016-12-19

Brief Summary

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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

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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CLL patients on Mabthera (rituximab)

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Semmelweis University, First Dept of Medicine

Budapest, , Hungary

Site Status

National Institute of Oncology, A Dept of Internal Medicine

Budapest, , Hungary

Site Status

Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika

Budapest, , Hungary

Site Status

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum; III. Belgyogyaszati Klinika

Debrecen, , Hungary

Site Status

Markhot Ferenc Oktato Korhaz es Rendelointezet; III. belgyogyaszat

Eger, , Hungary

Site Status

Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza; I. Belgyogyaszat-Hematologia Reszle

Gyula, , Hungary

Site Status

Miskolci Semmelweis Kórház és Egyetemi Oktatókórház; Haematology Dept.

Miskolc, , Hungary

Site Status

Josa Andras Korhaz; Ii. Sz. Belgyogyaszati Es Haematologiai Osztaly

Nyíregyháza, , Hungary

Site Status

University of Pecs, I st Dept of Internal Medicine

Pécs, , Hungary

Site Status

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika

Szeged, , Hungary

Site Status

Fejér Megyei Szent György Kórház; Hematologiai Osztaly

Székesfehérvár, , Hungary

Site Status

Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház; Onkológiai Osztály

Szolnok, , Hungary

Site Status

Vas Megyei Markusovszky Korhaz; Haematologiai Osztaly

Szombathely, , Hungary

Site Status

Szent Borbala Korhaz

Tatabanuya, , Hungary

Site Status

Veszprem Megyei Csolnoky Ferenc Korhaz Nonprofit Zrt.

Veszprém, , Hungary

Site Status

Countries

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Hungary

Other Identifiers

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ML29201

Identifier Type: -

Identifier Source: org_study_id

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