Lymphocytic Leukemia, Chronic Clinical Trial
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)
Verified date | November 2016 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 219 |
Est. completion date | February 2014 |
Est. primary completion date | February 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety profile of MabThera/Rituxan in combination with chemotherapy in unselected CLL patients | 3 years | No | |
Secondary | Efficacy (Response rate, duration of response, progression-free survival) | 3 years | No | |
Secondary | Chronic lymphocytic leukaemia (CLL) Comorboid Scale | 3 years | No | |
Secondary | Quality-adjusted survival analysis (Q-TWIST methodology) | 3 years | No |
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