Chronic Lymphocytic Leukemia
Conditions
Keywords
observational, chronic lymphocytic leukemia, bendamustine
Brief summary
Prospective multicenter observational non-interventional study to assess routine clinical practice of Bendamustine use in the first line therapy of chronic lymphocytic leukemia
Interventions
OTHERbendamustine
Routine practice
OTHERrituximab
Routine practice
Sponsors
Astellas Pharma Europe B.V.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with chronic lymphocytic leukemia (CLL) with current or planned first line therapy with Ribomustin * Informed Consent Form for personal data handling signed by the program participant
Exclusion criteria
* Any prior chemotherapy and/or radiotherapy and/or immunotherapy and/or any investigational agent for treatment of CLL * Currently participating in any clinical trial, and/or has taken an investigational drug within 28 days prior to enrollment * Contraindications for Ribomustin usage in accordance with product label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate | Within 60-90 days after end of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Treatment Failure (TF) | Within 60-90 days after end of treatment |
| Time to Progression (TTP) | 60 months |
| Progression-Free Survival (PFS) | 60 months |
| Adverse drug reactions | At all post-treatment visits (up to 30 days after end of treatment) |
| Overall survival | 60 months |
| Quality of Life of patients receiving Ribomustin therapy | At all post-treatment visits (up to 30 days after end of treatment) |
| Relapse following complete or partial remission | 60 months |
Countries
Russia
Outcome results
None listed