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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01224093
First received: October 18, 2010
Last updated: October 6, 2014
Last verified: October 2014
  Purpose

This prospective observational study will evaluate the safety of MabThera/Rituxa n (rituximab) in combination with chemotherapy in patients with previously untre ated or relapsed/refractory B cell-lineage chronic lymphocytic leukaemia. Data w ill 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 ] [ 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 ]

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

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
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, see Learn About Clinical Studies.

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

  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: October 6, 2014
Health Authority: Spain: Ministry of Health

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

ClinicalTrials.gov processed this record on October 23, 2014