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
NCT number | NCT02915224 |
Other study ID # | ML30133 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 23, 2016 |
Est. completion date | June 8, 2021 |
Verified date | June 2022 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Greece,
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 |
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