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

Hoffmann-La Roche11 sites in 1 country50 target enrollmentNovember 23, 2016

ConditionsChronic Lymphocytic Leukemia

InterventionsChlorambucil Obinutuzumab

DrugsChlorambucil Obinutuzumab

Overview

Phase: N/A
Intervention: Chlorambucil
Conditions: Chronic Lymphocytic Leukemia
Sponsor: Hoffmann-La Roche
Enrollment: 50
Locations: 11
Primary Endpoint: Progression Free Survival (PFS)\n
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 23, 2016

End Date

June 8, 2021

Last Updated

3 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

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

Arms & Interventions

Obinutuzumab

Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months.

Intervention: Chlorambucil

Obinutuzumab

Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months.

Intervention: Obinutuzumab

Outcomes

Primary Outcomes

Progression Free Survival (PFS)\n

Time Frame: From screening every 6 months to Month 18 until disease progression (up to 24 months)

Secondary Outcomes

Overall Survival (OS)(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 Response(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 Next Treatment, Defined as the Time Between the Date of Enrollment and First Intake of New Anti-Leukemic Therapy(Baseline up to 24 months)
Percentage of Participants With Dose Delays/Discontinuations(Baseline up to 24 months)
Number of Medical Procedures (Blood Transfusions, Bone Marrow, or Stem Cell Transplantation)(Baseline up to 24 months)
Costs of Treatment With Obinutuzumab(Baseline up to 24 months)
Duration of Response(From screening every 6 months to Month 18 until disease progression (up to 24 months))
Percentage of Participants With Protocol Defined Adverse Events of Particular Interest(Baseline up to 24 months)
Number of Diagnostic and Lab Exams(Baseline up to 24 months)
Percentage of Participants With Protocol Defined Adverse Events of Special Interest(Baseline up to 24 months)
Percentage of Participants With Non-hematological Toxicities(Baseline up to 24 months)
Number of Physician Visits(Baseline up to 24 months)
Percentage of Participants With Hematological Toxicities(Baseline up to 24 Months)
Number of Hospital Admissions(Baseline up to 24 months)