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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)

This study is currently recruiting participants.
Verified May 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01224093
First received: October 18, 2010
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Lymphocytic Leukemia, Chronic
 Drug: rituximab [MabThera/Rituxan]
Drug: Chemotherapy

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:

Drug Information available for: Rituximab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Efficacy (Response rate, duration of response, progression-free survival) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Chronic lymphocytic leukaemia (CLL) Comorboid Scale [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Quality-adjusted survival analysis (Q-TWIST methodology) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 216
Study Start Date: February 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
First line Drug: rituximab [MabThera/Rituxan]
as prescribed
Drug: Chemotherapy
as prescribed
Relapsed/refractory Drug: rituximab [MabThera/Rituxan]
as prescribed
Drug: Chemotherapy
as prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01224093

Contacts
Contact: Please reference Study ID Number: ML25372 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 55 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01224093     History of Changes
Other Study ID Numbers: ML25372
Study First Received: October 18, 2010
Last Updated: May 7, 2013
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Chronic Disease
Neoplasms by Histologic Type
Neoplasms
Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Disease Attributes
Pathologic Processes
Rituximab
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on May 19, 2013