A Study of Obinutuzumab Evaluating Efficacy, Safety and Cost of Disease Management in Participants With Chronic Lymphocytic Leukemia and Comorbidities
A Multicenter, Single Arm, Non-Interventional, Observational Study of Obinutuzumab to Evaluate Efficacy, Safety and Cost of Disease Management in Patients With Chronic Lymphocytic Leukemia and Comorbidities in Greece
1 other identifier
observational
50
1 country
11
Brief Summary
This multicenter, single arm, non-interventional, observational study will evaluate the efficacy and safety of obinutuzumab in daily clinical practice in participants with chronic lymphocytic leukemia (CLL). The study will also assess cost of disease management. The total length of the study is 42 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2016
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 23, 2016
CompletedFirst Posted
Study publicly available on registry
September 26, 2016
CompletedStudy Start
First participant enrolled
November 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 8, 2021
CompletedJune 28, 2022
June 1, 2022
4.5 years
September 23, 2016
June 27, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)\n
From screening every 6 months to Month 18 until disease progression (up to 24 months)
Secondary Outcomes (16)
Overall Survival (OS)
From screening every 6 months to Month 18 until disease progression (up to 24 months)
Percentage of Participants With Overall Response as Assessed by Investigator
From screening every 6 months to Month 18 until disease progression (up to 24 months)
Time to Response
From screening every 6 months to Month 18 until disease progression (up to 24 months)
Percentage of Participants With Best Overall Response as Assessed by Investigator
From screening every 6 months to Month 18 until disease progression (up to 24 months)
Time to Next Treatment, Defined as the Time Between the Date of Enrollment and First Intake of New Anti-Leukemic Therapy
Baseline up to 24 months
- +11 more secondary outcomes
Study Arms (1)
Obinutuzumab
Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months.
Interventions
Participants will receive chlorambucil as per summary of product characteristics in daily practice. Protocol does not specify any dosage.
Participants will receive obinutuzumab as per summary of product characteristics in daily practice. Protocol does not specify any dosage.
Eligibility Criteria
Participants receiving obinutuzumab for CLL and comorbidities
You may qualify if:
- Participants with untreated CLL and comorbidities, for which the physician has already decided to use obinutuzumab in association with chlorambucil
You may not qualify if:
- Participation in another clinical trial during the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
University General Hospital of Alexandroupolis; Haemotology
Alexandroup, 068100, Greece
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
Athens, 115 27, Greece
Laiko General Hospital; Hematology Clinic
Athens, 115 27, Greece
General Hospital G. Gennimatas; Hematology Dept.
Athens, 11527, Greece
Attiko Hospital; Haematology Clinic
Athens, 124 62, Greece
Periph. University General Hospital of Heraklion; Hematology
Heraklion, 711 10, Greece
University Hospital of Larissa; Hematology Dept.
Larissa, 411100, Greece
University General Hospital of Patra; Internal Medicine Clinic - Hematology Department
Pátrai, 26504, Greece
Metaxa Hospital; Hematology Clinic
Piraeus, 18537, Greece
AXEPA Pathology Section; A Pathology Clinic
Thessaloniki, 54636, Greece
General Hospital G. Papanikolaou; Hematology, BMT Unit
Thessaloniki, 570 10, Greece
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 23, 2016
First Posted
September 26, 2016
Study Start
November 23, 2016
Primary Completion
June 8, 2021
Study Completion
June 8, 2021
Last Updated
June 28, 2022
Record last verified: 2022-06