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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)

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ClinicalTrials.gov Identifier: NCT01224093
Recruitment Status : Completed
First Posted : October 19, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

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

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 : October 2010
Primary Completion Date : February 2014
Study Completion Date : February 2014


Groups and Cohorts

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


Outcome Measures

Primary Outcome Measures :
  1. Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Efficacy (Response rate, duration of response, progression-free survival) [ Time Frame: 3 years ]
  2. Chronic lymphocytic leukaemia (CLL) Comorboid Scale [ Time Frame: 3 years ]
  3. Quality-adjusted survival analysis (Q-TWIST methodology) [ Time Frame: 3 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01224093


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01224093     History of Changes
Other Study ID Numbers: ML25372
First Posted: October 19, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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