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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01224093
First Posted: October 19, 2010
Last Update Posted: November 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  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: Chemotherapy Drug: rituximab [MabThera/Rituxan]

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:


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 ]

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

Enrollment: 219
Study Start Date: October 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
First line Drug: Chemotherapy
as prescribed
Drug: rituximab [MabThera/Rituxan]
as prescribed
Relapsed/refractory Drug: Chemotherapy
as prescribed
Drug: rituximab [MabThera/Rituxan]
as prescribed

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: October 18, 2010
First Posted: October 19, 2010
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