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)
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)
1 other identifier
observational
219
1 country
55
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2010
Typical duration for all trials
55 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 18, 2010
CompletedFirst Posted
Study publicly available on registry
October 19, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedNovember 2, 2016
November 1, 2016
3.3 years
October 18, 2010
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients
3 years
Secondary Outcomes (3)
Efficacy (Response rate, duration of response, progression-free survival)
3 years
Chronic lymphocytic leukaemia (CLL) Comorboid Scale
3 years
Quality-adjusted survival analysis (Q-TWIST methodology)
3 years
Study Arms (2)
First line
Relapsed/refractory
Interventions
Eligibility Criteria
Patients with B cell-lineage chronic lymphocytic leukaemia (B-CLL)
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (55)
Unknown Facility
Vitoria-Gasteiz, Alava, 01009, Spain
Unknown Facility
Alicante, Alicante, 03010, Spain
Unknown Facility
Elche, Alicante, 03203, Spain
Unknown Facility
Almería, Almeria, 04009, Spain
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Palma de Mallorca, Balearic Islands, 07014, Spain
Unknown Facility
Palma de Mallorca, Balearic Islands, 07198, Spain
Unknown Facility
Badalona, Barcelona, 08915, Spain
Unknown Facility
Barcelona, Barcelona, 08025, Spain
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Barcelona, Barcelona, 08035, Spain
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Barcelona, Barcelona, 08907, Spain
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Sabadell, Barcelona, 08208, Spain
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Cadiz, Cadiz, 11009, Spain
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Jerez de la Frontera, Cadiz, 11407, Spain
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Puerto Real, Cadiz, 11510, Spain
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Santander, Cantabria, 39008, Spain
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Castellon, Castellon, 12004, Spain
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Girona, Girona, 17007, Spain
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Huelva, Huelva, 21005, Spain
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Jaén, Jaen, 23007, Spain
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Ferrol, La Coruña, 15405, Spain
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Logroño, La Rioja, 26006, Spain
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Las Palmas, Las Palmas, 35020, Spain
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Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
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León, Leon, 24071, Spain
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Lleida, Lerida, 25198, Spain
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Alcorcón, Madrid, 28922, Spain
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Madrid, Madrid, 28007, Spain
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Madrid, Madrid, 28031, Spain
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Madrid, Madrid, 28034, Spain
Unknown Facility
Madrid, Madrid, 28040, Spain
Unknown Facility
Madrid, Madrid, 28041, Spain
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Madrid, Madrid, 28046, Spain
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Madrid, Madrid, 28222, Spain
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Madrid, Madrid, 28905, Spain
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Málaga, Malaga, 29010, Spain
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Málaga, Malaga, 29600, Spain
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Cartagena, Murcia, 30203, Spain
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Lorca, Murcia, 30800, Spain
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Pamplona, Navarre, 31008, Spain
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Gijón, Principality of Asturias, 33203, Spain
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Oviedo, Principality of Asturias, 33011, Spain
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Seville, Sevilla, 41009, Spain
Unknown Facility
Seville, Sevilla, 41013, Spain
Unknown Facility
Seville, Sevilla, 41014, Spain
Unknown Facility
Tarragona, Tarragona, 43007, Spain
Unknown Facility
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Unknown Facility
Santa Cruz de Tenerife, Tenerife, 38010, Spain
Unknown Facility
Alzira, Valencia, 46600, Spain
Unknown Facility
Valencia, Valencia, 46010, Spain
Unknown Facility
Valencia, Valencia, 46014, Spain
Unknown Facility
Valencia, Valencia, 46017, Spain
Unknown Facility
Valencia, Valencia, 46026, Spain
Unknown Facility
Valladolid, Valladolid, 47010, Spain
Unknown Facility
Bilbao, Vizcaya, 48013, Spain
Unknown Facility
Zaragoza, Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 18, 2010
First Posted
October 19, 2010
Study Start
October 1, 2010
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
November 2, 2016
Record last verified: 2016-11