Clinical trial NCT01224093: 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)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymphocytic Leukemia, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-10-19
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with B cell-lineage chronic lymphocytic leukaemia (B-CLL)

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.


Eligibility criteria: 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

Primary outcomes:
measure: Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients
timeFrame: 3 years
Secondary outcomes:
measure: Efficacy (Response rate, duration of response, progression-free survival)
timeFrame: 3 years
measure: Chronic lymphocytic leukaemia (CLL) Comorboid Scale
timeFrame: 3 years
measure: Quality-adjusted survival analysis (Q-TWIST methodology)
timeFrame: 3 years
Other outcomes:
Locations:
city: Vitoria
country: Spain
state: Alava
city: Elche
country: Spain
state: Alicante
city: Gijon
country: Spain
state: Asturias
city: Oviedo
country: Spain
state: Asturias
city: Badalona
country: Spain
state: Barcelona
city: Sabadell
country: Spain
state: Barcelona
city: Cádiz
country: Spain
state: Cadiz
city: Jerez de La Frontera
country: Spain
state: Cadiz
city: Puerto Real
country: Spain
state: Cadiz
city: Santander
country: Spain
state: Cantabria
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Ferrol
country: Spain
state: La Coruña
city: Logroño
country: Spain
state: La Rioja
city: Las Palmas de Gran Canaria
country: Spain
state: Las Palmas
city: Alcorcon
country: Spain
state: Madrid
city: Cartagena
country: Spain
state: Murcia
city: Lorca
country: Spain
state: Murcia
city: Pamplona
country: Spain
state: Navarra
city: La Laguna
country: Spain
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
state: Tenerife
city: Alzira
country: Spain
state: Valencia
city: Bilbao
country: Spain
state: Vizcaya
city: Alicante
country: Spain
city: Almeria
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Castellon
country: Spain
city: Girona
country: Spain
city: Huelva
country: Spain
city: Jaen
country: Spain
city: Las Palmas
country: Spain
city: Leon
country: Spain
city: Lerida
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Malaga
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Sevilla
country: Spain
city: Tarragona
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
city: Valladolid
country: Spain
city: Zaragoza
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: