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

NCT ID: NCT02915224

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-23

Study Completion Date

2021-06-08

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Lymphocytic Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Obinutuzumab

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

Chlorambucil

Intervention Type DRUG

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

Obinutuzumab

Intervention Type DRUG

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

Interventions

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Chlorambucil

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

Intervention Type DRUG

Obinutuzumab

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

Intervention Type DRUG

Other Intervention Names

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Gazyvaro®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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University General Hospital of Alexandroupolis; Haemotology

Alexandroup, , Greece

Site Status

Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine

Athens, , Greece

Site Status

Laiko General Hospital; Hematology Clinic

Athens, , Greece

Site Status

General Hospital G. Gennimatas; Hematology Dept.

Athens, , Greece

Site Status

Attiko Hospital; Haematology Clinic

Athens, , Greece

Site Status

Periph. University General Hospital of Heraklion; Hematology

Heraklion, , Greece

Site Status

University Hospital of Larissa; Hematology Dept.

Larissa, , Greece

Site Status

University General Hospital of Patra; Internal Medicine Clinic - Hematology Department

Pátrai, , Greece

Site Status

Metaxa Hospital; Hematology Clinic

Piraeus, , Greece

Site Status

AXEPA Pathology Section; A Pathology Clinic

Thessaloniki, , Greece

Site Status

General Hospital G. Papanikolaou; Hematology, BMT Unit

Thessaloniki, , Greece

Site Status

Countries

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Greece

Other Identifiers

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ML30133

Identifier Type: -

Identifier Source: org_study_id

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