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

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ClinicalTrials.gov Identifier: NCT02915224
Recruitment Status : Recruiting
First Posted : September 26, 2016
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief 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.

Condition or disease Intervention/treatment
Chronic Lymphocytic Leukemia Drug: Chlorambucil Drug: Obinutuzumab

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Actual Study Start Date : November 23, 2016
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020


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 Name: Gazyvaro®




Primary Outcome Measures :
  1. Progression Free Survival (PFS)\n [ Time Frame: From screening every 6 months to Month 18 until disease progression (up to 24 months) ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants receiving obinutuzumab for CLL and comorbidities
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02915224


Contacts
Contact: Reference Study ID Number: ML30133 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
Greece
University General Hospital of Alexandroupolis; Haemotology Recruiting
Alexandroupolis, Greece, 68100
Laiko General Hospital of Athens; A Propedeutical Clinic of Internal Medicine Recruiting
Athens, Greece, 115 27
Laiko General Hospital; Hematology Clinic Recruiting
Athens, Greece, 115 27
General Hospital G. Gennimatas; Hematology Dept. Recruiting
Athens, Greece, 11527
Attiko Hospital; Haematology Clinic Recruiting
Athens, Greece, 124 62
Periph. University General Hospital of Heraklion; Hematology Recruiting
Heraklion, Greece, 711 10
University Hospital of Larissa; Hematology Dept. Recruiting
Larissa, Greece, 41110
University General Hospital of Patra; Internal Medicine Clinic - Hematology Department Recruiting
Patra, Greece, 26504
Metaxa Hospital; Hematology Clinic Recruiting
Peiraias, Greece, 18537
Iatriko Psichikou Terminated
Psichiko Athens, Greece, 11525
Theagenio Anticancer Hospital; Dept. of Haematology Terminated
Thessaloniki, Greece, 54007
AXEPA Pathology Section; A Pathology Clinic Recruiting
Thessaloniki, Greece, 54636
General Hospital G. Papanikolaou; Hematology, BMT Unit Recruiting
Thessaloniki, Greece, 570 10
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02915224     History of Changes
Other Study ID Numbers: ML30133
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Obinutuzumab
Chlorambucil
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action