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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)


N/A
18 Years
N/A
Open (Enrolling)
Both
Lymphocytic Leukemia, Chronic

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Trial Information

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)


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Spain: Ministry of Health

Study ID:

ML25372

NCT ID:

NCT01224093

Start Date:

October 2010

Completion Date:

January 2014

Related Keywords:

  • Lymphocytic Leukemia, Chronic
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Chronic Disease

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