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

Chronic Lymphocytic Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02915224
• Other study ID #: ML30133
• Status: Completed
• Start date: November 23, 2016
• Est. completion date: June 8, 2021

Study information

• Verified date: June 2022
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 8, 2021
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Drug:
• Chlorambucil
Participants will receive chlorambucil as per summary of product characteristics in daily practice. Protocol does not specify any dosage.
• Obinutuzumab
Participants will receive obinutuzumab as per summary of product characteristics in daily practice. Protocol does not specify any dosage.

Locations

Country	Name	City	State
Greece	University General Hospital of Alexandroupolis; Haemotology	Alexandroup
Greece	Attiko Hospital; Haematology Clinic	Athens
Greece	General Hospital G. Gennimatas; Hematology Dept.	Athens
Greece	Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine	Athens
Greece	Laiko General Hospital; Hematology Clinic	Athens
Greece	Periph. University General Hospital of Heraklion; Hematology	Heraklion
Greece	University Hospital of Larissa; Hematology Dept.	Larissa
Greece	University General Hospital of Patra; Internal Medicine Clinic - Hematology Department	Patra
Greece	Metaxa Hospital; Hematology Clinic	Peiraias
Greece	AXEPA Pathology Section; A Pathology Clinic	Thessaloniki
Greece	General Hospital G. Papanikolaou; Hematology, BMT Unit	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Greece, 

Outcome

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