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)

Sponsor
Hoffmann-La Roche
Study ID
NCT01224093
Status
Completed

Conditions

  • Lymphocytic Leukemia, Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 31, 2010
Status verified
Nov 2016
Primary completion
Feb 28, 2014
Completion
Feb 28, 2014

Study Design

Enrollment
219 participants (actual)

Arms

  • Arm: First line
  • Arm: Relapsed/refractory

Primary Outcome Measure

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

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