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)

November 1, 2016 updated by: Hoffmann-La Roche

A Multicentre, Observational, Prospective Study to Assess the Safety Profile of Rituximab in Combination With Chemotherapy in Patients With B Cell-lineage Chronic Lymphocytic Leukaemia (B-CLL)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

219

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Alicante, Spain, 03010
      • Almeria, Spain, 04009
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08907
      • Barcelona, Spain, 08025
      • Castellon, Spain, 12004
      • Girona, Spain, 17007
      • Huelva, Spain, 21005
      • Jaen, Spain, 23007
      • Las Palmas, Spain, 35020
      • Leon, Spain, 24071
      • Lerida, Spain, 25198
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
      • Madrid, Spain, 28034
      • Madrid, Spain, 28905
      • Madrid, Spain, 28041
      • Madrid, Spain, 28007
      • Madrid, Spain, 28222
      • Madrid, Spain, 28031
      • Malaga, Spain, 29010
      • Malaga, Spain, 29600
      • Sevilla, Spain, 41014
      • Sevilla, Spain, 41013
      • Sevilla, Spain, 41009
      • Tarragona, Spain, 43007
      • Valencia, Spain, 46017
      • Valencia, Spain, 46014
      • Valencia, Spain, 46026
      • Valencia, Spain, 46010
      • Valladolid, Spain, 47010
      • Zaragoza, Spain, 50009
    • Alava
      • Vitoria, Alava, Spain, 01009
    • Alicante
      • Elche, Alicante, Spain, 03203
    • Asturias
      • Gijon, Asturias, Spain, 33203
      • Oviedo, Asturias, Spain, 33011
    • Barcelona
      • Badalona, Barcelona, Spain, 08915
      • Sabadell, Barcelona, Spain, 08208
    • Cadiz
      • Cádiz, Cadiz, Spain, 11009
      • Jerez de La Frontera, Cadiz, Spain, 11407
      • Puerto Real, Cadiz, Spain, 11510
    • Cantabria
      • Santander, Cantabria, Spain, 39008
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07198
      • Palma de Mallorca, Islas Baleares, Spain, 07014
    • La Coruña
      • Ferrol, La Coruña, Spain, 15405
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
    • Madrid
      • Alcorcon, Madrid, Spain, 28922
    • Murcia
      • Cartagena, Murcia, Spain, 30203
      • Lorca, Murcia, Spain, 30800
    • Navarra
      • Pamplona, Navarra, Spain, 31008
    • Tenerife
      • La Laguna, Tenerife, Spain, 38320
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
    • Valencia
      • Alzira, Valencia, Spain, 46600
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with B cell-lineage chronic lymphocytic leukaemia (B-CLL)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
First line
Drug: Chemotherapy
as prescribed
Drug: rituximab [MabThera/Rituxan]
as prescribed
Relapsed/refractory
Drug: Chemotherapy
as prescribed
Drug: rituximab [MabThera/Rituxan]
as prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy (Response rate, duration of response, progression-free survival)
Time Frame: 3 years
3 years
Chronic lymphocytic leukaemia (CLL) Comorboid Scale
Time Frame: 3 years
3 years
Quality-adjusted survival analysis (Q-TWIST methodology)
Time Frame: 3 years
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

October 18, 2010

First Submitted That Met QC Criteria

October 18, 2010

First Posted (Estimate)

October 19, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25372

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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