Clinical trial NCT02915224: A Study of Obinutuzumab Evaluating Efficacy, Safety and Cost of Disease Management in Participants With Chronic Lymphocytic Leukemia and Comorbidities
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-09-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants receiving obinutuzumab for CLL and comorbidities

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.


Eligibility criteria: Inclusion Criteria:

* Participants with untreated CLL and comorbidities, for which the physician has already decided to use obinutuzumab in association with chlorambucil

Exclusion Criteria:

* Participation in another clinical trial during the study

Primary outcomes:
measure: Progression Free Survival (PFS)\n
timeFrame: From screening every 6 months to Month 18 until disease progression (up to 24 months)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From screening every 6 months to Month 18 until disease progression (up to 24 months)
measure: Percentage of Participants With Overall Response as Assessed by Investigator
timeFrame: From screening every 6 months to Month 18 until disease progression (up to 24 months)
measure: Time to Response
timeFrame: From screening every 6 months to Month 18 until disease progression (up to 24 months)
measure: Percentage of Participants With Best Overall Response as Assessed by Investigator
timeFrame: From screening every 6 months to Month 18 until disease progression (up to 24 months)
measure: Time to Next Treatment, Defined as the Time Between the Date of Enrollment and First Intake of New Anti-Leukemic Therapy
timeFrame: Baseline up to 24 months
measure: Duration of Response
timeFrame: From screening every 6 months to Month 18 until disease progression (up to 24 months)
measure: Percentage of Participants With Protocol Defined Adverse Events of Special Interest
timeFrame: Baseline up to 24 months
measure: Percentage of Participants With Protocol Defined Adverse Events of Particular Interest
timeFrame: Baseline up to 24 months
measure: Percentage of Participants With Dose Delays/Discontinuations
timeFrame: Baseline up to 24 months
measure: Percentage of Participants With Hematological Toxicities
timeFrame: Baseline up to 24 Months
measure: Percentage of Participants With Non-hematological Toxicities
timeFrame: Baseline up to 24 months
measure: Number of Hospital Admissions
timeFrame: Baseline up to 24 months
measure: Number of Physician Visits
timeFrame: Baseline up to 24 months
measure: Number of Diagnostic and Lab Exams
timeFrame: Baseline up to 24 months
measure: Number of Medical Procedures (Blood Transfusions, Bone Marrow, or Stem Cell Transplantation)
timeFrame: Baseline up to 24 months
measure: Costs of Treatment With Obinutuzumab
timeFrame: Baseline up to 24 months
Other outcomes:
Locations:
city: Alexandroup
country: Greece
facility: University General Hospital of Alexandroupolis; Haemotology
city: Athens
country: Greece
facility: Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
city: Athens
country: Greece
facility: Laiko General Hospital; Hematology Clinic
city: Athens
country: Greece
facility: General Hospital G. Gennimatas; Hematology Dept.
city: Athens
country: Greece
facility: Attiko Hospital; Haematology Clinic
city: Heraklion
country: Greece
facility: Periph. University General Hospital of Heraklion; Hematology
city: Larissa
country: Greece
facility: University Hospital of Larissa; Hematology Dept.
city: Patra
country: Greece
facility: University General Hospital of Patra; Internal Medicine Clinic - Hematology Department
city: Peiraias
country: Greece
facility: Metaxa Hospital; Hematology Clinic
city: Thessaloniki
country: Greece
facility: AXEPA Pathology Section; A Pathology Clinic
city: Thessaloniki
country: Greece
facility: General Hospital G. Papanikolaou; Hematology, BMT Unit
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: