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NCT Number: NCT02915224

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

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.

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Key information

Conditions

Chronic Lymphocytic Leukemia Chronic Disease Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, B-Cell Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University General Hospital of Alexandroupolis; Haemotology, Alexandroup, Greece

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chlorambucil

Drug

Participants will receive chlorambucil as per summary of product characteristics in daily practice. Protocol does not specify any dosage.

Obinutuzumab

Drug

Participants will receive obinutuzumab as per summary of product characteristics in daily practice. Protocol does not specify any dosage.

Other names: Gazyvaro®

Primary outcomes

  1. Progression Free Survival (PFS)\n

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

Secondary outcomes

  1. Overall Survival (OS)

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

  2. 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)

  3. Time to Response

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

  4. 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)

  5. 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

  6. Duration of Response

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

  7. Percentage of Participants With Protocol Defined Adverse Events of Special Interest

    Time frame: Baseline up to 24 months

  8. Percentage of Participants With Protocol Defined Adverse Events of Particular Interest

    Time frame: Baseline up to 24 months

  9. Percentage of Participants With Dose Delays/Discontinuations

    Time frame: Baseline up to 24 months

  10. Percentage of Participants With Hematological Toxicities

    Time frame: Baseline up to 24 Months

  11. Percentage of Participants With Non-hematological Toxicities

    Time frame: Baseline up to 24 months

  12. Number of Hospital Admissions

    Time frame: Baseline up to 24 months

  13. Number of Physician Visits

    Time frame: Baseline up to 24 months

  14. Number of Diagnostic and Lab Exams

    Time frame: Baseline up to 24 months

  15. Number of Medical Procedures (Blood Transfusions, Bone Marrow, or Stem Cell Transplantation)

    Time frame: Baseline up to 24 months

  16. Costs of Treatment With Obinutuzumab

    Time frame: Baseline up to 24 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Sep 26, 2016
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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