An Observational Study on the Safety Profile of MabThera/Rituxan (Rituximab) in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (MABERYC)

NCT ID: NCT01224093

Last Updated: 2016-11-02

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

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-02-28

Brief Summary

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This prospective observational study will evaluate the safety of MabThera/Rituxan (rituximab) in combination with chemotherapy in patients with previously untreated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data will be collected from each patient for 6-12 months, depending on the prescribed chemotherapy regimen.

Detailed Description

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Conditions

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Lymphocytic Leukemia, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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First line

Chemotherapy

Intervention Type DRUG

as prescribed

rituximab [MabThera/Rituxan]

Intervention Type DRUG

as prescribed

Relapsed/refractory

Chemotherapy

Intervention Type DRUG

as prescribed

rituximab [MabThera/Rituxan]

Intervention Type DRUG

as prescribed

Interventions

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Chemotherapy

as prescribed

Intervention Type DRUG

rituximab [MabThera/Rituxan]

as prescribed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* B cell-lineage chronic lymphocytic leukaemia (B-CLL)
* Prescribed with MabThera/Rituxan in combination with chemotherapy according to the approved SMPC
* Informed consent to data collection

Exclusion Criteria

* Treatment with any marketed or non-marketed drug substance or experimental therapy within 4 weeks prior to first dose of study drug or participation in a clinical trial within 30 days prior to entering this study
* Any other tumour disease
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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Vitoria-Gasteiz, Alava, Spain

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Alicante, Alicante, Spain

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Elche, Alicante, Spain

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Almería, Almeria, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Palma de Mallorca, Balearic Islands, Spain

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Badalona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Cadiz, Cadiz, Spain

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Jerez de la Frontera, Cadiz, Spain

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Puerto Real, Cadiz, Spain

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Santander, Cantabria, Spain

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Castellon, Castellon, Spain

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Girona, Girona, Spain

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Huelva, Huelva, Spain

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Jaén, Jaen, Spain

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Ferrol, La Coruña, Spain

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Logroño, La Rioja, Spain

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Las Palmas, Las Palmas, Spain

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Las Palmas de Gran Canaria, Las Palmas, Spain

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León, Leon, Spain

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Lleida, Lerida, Spain

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Alcorcón, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Málaga, Malaga, Spain

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Málaga, Malaga, Spain

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Cartagena, Murcia, Spain

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Lorca, Murcia, Spain

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Pamplona, Navarre, Spain

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Gijón, Principality of Asturias, Spain

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Oviedo, Principality of Asturias, Spain

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Seville, Sevilla, Spain

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Seville, Sevilla, Spain

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Seville, Sevilla, Spain

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Tarragona, Tarragona, Spain

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San Cristóbal de La Laguna, Tenerife, Spain

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Santa Cruz de Tenerife, Tenerife, Spain

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Alzira, Valencia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Valladolid, Valladolid, Spain

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Bilbao, Vizcaya, Spain

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Zaragoza, Zaragoza, Spain

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Countries

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Spain

Other Identifiers

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ML25372

Identifier Type: -

Identifier Source: org_study_id