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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)

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01224093
Collaborator
(none)
219
Enrollment
55
Locations
40
Duration (Months)
4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
219 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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 Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
Feb 1, 2014

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients [3 years]

Secondary Outcome Measures

  1. Efficacy (Response rate, duration of response, progression-free survival) [3 years]

  2. Chronic lymphocytic leukaemia (CLL) Comorboid Scale [3 years]

  3. Quality-adjusted survival analysis (Q-TWIST methodology) [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vitoria Alava Spain 01009
2 Elche Alicante Spain 03203
3 Gijon Asturias Spain 33203
4 Oviedo Asturias Spain 33011
5 Badalona Barcelona Spain 08915
6 Sabadell Barcelona Spain 08208
7 Cádiz Cadiz Spain 11009
8 Jerez de La Frontera Cadiz Spain 11407
9 Puerto Real Cadiz Spain 11510
10 Santander Cantabria Spain 39008
11 Palma de Mallorca Islas Baleares Spain 07014
12 Palma de Mallorca Islas Baleares Spain 07198
13 Ferrol La Coruña Spain 15405
14 Logroño La Rioja Spain 26006
15 Las Palmas de Gran Canaria Las Palmas Spain 35016
16 Alcorcon Madrid Spain 28922
17 Cartagena Murcia Spain 30203
18 Lorca Murcia Spain 30800
19 Pamplona Navarra Spain 31008
20 La Laguna Tenerife Spain 38320
21 Santa Cruz de Tenerife Tenerife Spain 38010
22 Alzira Valencia Spain 46600
23 Bilbao Vizcaya Spain 48013
24 Alicante Spain 03010
25 Almeria Spain 04009
26 Barcelona Spain 08025
27 Barcelona Spain 08035
28 Barcelona Spain 08907
29 Castellon Spain 12004
30 Girona Spain 17007
31 Huelva Spain 21005
32 Jaen Spain 23007
33 Las Palmas Spain 35020
34 Leon Spain 24071
35 Lerida Spain 25198
36 Madrid Spain 28007
37 Madrid Spain 28031
38 Madrid Spain 28034
39 Madrid Spain 28040
40 Madrid Spain 28041
41 Madrid Spain 28046
42 Madrid Spain 28222
43 Madrid Spain 28905
44 Malaga Spain 29010
45 Malaga Spain 29600
46 Sevilla Spain 41009
47 Sevilla Spain 41013
48 Sevilla Spain 41014
49 Tarragona Spain 43007
50 Valencia Spain 46010
51 Valencia Spain 46014
52 Valencia Spain 46017
53 Valencia Spain 46026
54 Valladolid Spain 47010
55 Zaragoza Spain 50009

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01224093
Other Study ID Numbers:
  • ML25372
First Posted:
Oct 19, 2010
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Rituximab

Study Results

No Results Posted as of Nov 2, 2016