A Study of Obinutuzumab Evaluating Efficacy, Safety and Cost of Disease Management in Participants With Chronic Lymphocytic Leukemia and Comorbidities

June 27, 2022 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroup, Greece, 068100
        • University General Hospital of Alexandroupolis; Haemotology
      • Athens, Greece, 124 62
        • Attiko Hospital; Haematology Clinic
      • Athens, Greece, 115 27
        • Laiko General Hospital; Hematology Clinic
      • Athens, Greece, 115 27
        • Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine
      • Athens, Greece, 11527
        • General Hospital G. Gennimatas; Hematology Dept.
      • Heraklion, Greece, 711 10
        • Periph. University General Hospital of Heraklion; Hematology
      • Larissa, Greece, 411100
        • University Hospital of Larissa; Hematology Dept.
      • Patra, Greece, 26504
        • University General Hospital of Patra; Internal Medicine Clinic - Hematology Department
      • Peiraias, Greece, 18537
        • Metaxa Hospital; Hematology Clinic
      • Thessaloniki, Greece, 54636
        • AXEPA Pathology Section; A Pathology Clinic
      • Thessaloniki, Greece, 570 10
        • General Hospital G. Papanikolaou; Hematology, BMT Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants receiving obinutuzumab for CLL and comorbidities

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Obinutuzumab
Participants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months.
Drug: Chlorambucil
Participants will receive chlorambucil as per summary of product characteristics in daily practice. Protocol does not specify any dosage.
Drug: Obinutuzumab
Participants will receive obinutuzumab as per summary of product characteristics in daily practice. Protocol does not specify any dosage.
Other Names:
  • Gazyvaro®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival (PFS)\n
Time Frame: From screening every 6 months to Month 18 until disease progression (up to 24 months)
From screening every 6 months to Month 18 until disease progression (up to 24 months)

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 23, 2016

Primary Completion (Actual)

June 8, 2021

Study Completion (Actual)

June 8, 2021

Study Registration Dates

First Submitted

September 23, 2016

First Submitted That Met QC Criteria

September 23, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

June 28, 2022

Last Update Submitted That Met QC Criteria

June 27, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML30133

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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