NCT02110394CompletedNot Applicable
Observational Program for Evaluation of Ribomustin Use in the First Line Therapy of Chronic Lymphocytic Leukemia
Astellas Pharma Europe B.V.34 sites in 1 country190 target enrollmentStarted: June 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Astellas Pharma Europe B.V.
- Enrollment
- 190
- Locations
- 34
- Primary Endpoint
- Overall response rate
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Overall response rate
Time Frame: Within 60-90 days after end of treatment
Secondary Outcomes
- Time to Progression (TTP)(60 months)
- Adverse drug reactions(At all post-treatment visits (up to 30 days after end of treatment))
- Treatment Failure (TF)(Within 60-90 days after end of treatment)
- Progression-Free Survival (PFS)(60 months)
- Relapse following complete or partial remission(60 months)
- 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))
Investigators
Study Sites (34)
Loading locations...
Similar Trials
Completed
Not Applicable
Ribomustin in the Second Line Therapy of Relapsed or Refractory Indolent B-cell Non-Hodgkin's LymphomaLymphoma, Non-HodgkinNCT02072967Astellas Pharma Europe B.V.97
Completed
Not Applicable
An Observational Study on the Safety and Effectiveness of Rituximab in Patients With Severe Active Rheumatoid ArthritisRheumatoid ArthritisNCT01071798Hoffmann-La Roche1,653
Completed
Not Applicable
An Observational Study of First-Line Maintenance Rituximab (MabThera/Rituxan) in Participants With Follicular Non-Hodgkin's LymphomaNon-Hodgkin's LymphomaNCT01684865Hoffmann-La Roche22
Completed
Not Applicable
A Study of Rituximab (MabThera) in Combination With Chemotherapy in Participants With CD20-Positive B-Cell Chronic Lymphocytic LeukemiaLymphocytic Leukemia, ChronicNCT01609023Hoffmann-La Roche67
Completed
Phase 3
A Study to Assess the Effect of Maintenance Treatment With Rituximab Versus No Treatment in Participants With Progressive B-Cell Chronic Lymphocytic Leukemia (CLL)Lymphocytic Leukemia, ChronicNCT00718549Hoffmann-La Roche128