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Completed

NCT Number: NCT01224093

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 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.

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Key information

Conditions

Lymphocytic Leukemia, Chronic Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vitoria-Gasteiz, Alava, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

as prescribed

rituximab [MabThera/Rituxan]

Drug

as prescribed

Primary outcomes

  1. Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients

    Time frame: 3 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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)

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 19, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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