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Chronic Lymphocytic LeukemiaNCT02915224

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

An observational study of Chronic Lymphocytic Leukemia, run by Hoffmann-La Roche at 11 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia
What is being tested?
Chlorambucil and Obinutuzumab
How many people
50 participants
Where
11 sitesGreece
Study dates
23 Nov 2016to 8 Jun 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants receiving obinutuzumab for CLL and comorbidities

Who may be able to join

  • Participants with untreated CLL and comorbidities, for which the physician has already decided to use obinutuzumab in association with chlorambucil

Who cannot join

  • Participation in another clinical trial during the study

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Greece11 sites

  • University General Hospital of Alexandroupolis; Haemotology

    Alexandroup, 068100

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

    Athens, 115 27

  • Laiko General Hospital; Hematology Clinic

    Athens, 115 27

  • General Hospital G. Gennimatas; Hematology Dept.

    Athens, 11527

  • Attiko Hospital; Haematology Clinic

    Athens, 124 62

  • Periph. University General Hospital of Heraklion; Hematology

    Heraklion, 711 10

  • University Hospital of Larissa; Hematology Dept.

    Larissa, 411100

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

    Pátrai, 26504

  • Metaxa Hospital; Hematology Clinic

    Piraeus, 18537

  • AXEPA Pathology Section; A Pathology Clinic

    Thessaloniki, 54636

  • General Hospital G. Papanikolaou; Hematology, BMT Unit

    Thessaloniki, 570 10

Other trials in Greece

About this study

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

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.

Being tested
Chlorambucil, Obinutuzumab
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ChlorambucilDrug

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

  • ObinutuzumabDrug

    Also called Gazyvaro®

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

Study groups in NCT02915224
Study groupRoleWhat they receive
ObinutuzumabParticipants will receive obinutuzumab as per Summary of Product Characteristics in daily practice along with chlorambucil for 24 months.
Receives: Drug: Chlorambucil; Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS)\n

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

Secondary outcomes (16)

  1. Overall Survival (OS)

    Measured: 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

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

  3. Time to Response

    Measured: 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

    Measured: 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

    Measured: Baseline up to 24 months

  6. Duration of Response

    Measured: 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

    Measured: Baseline up to 24 months

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

    Measured: Baseline up to 24 months

  9. Percentage of Participants With Dose Delays/Discontinuations

    Measured: Baseline up to 24 months

  10. Percentage of Participants With Hematological Toxicities

    Measured: Baseline up to 24 Months

  11. Percentage of Participants With Non-hematological Toxicities

    Measured: Baseline up to 24 months

  12. Number of Hospital Admissions

    Measured: Baseline up to 24 months

  13. Number of Physician Visits

    Measured: Baseline up to 24 months

  14. Number of Diagnostic and Lab Exams

    Measured: Baseline up to 24 months

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

    Measured: Baseline up to 24 months

  16. Costs of Treatment With Obinutuzumab

    Measured: Baseline up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2016 (estimated)
  2. Study start23 Nov 2016
  3. Primary completion8 Jun 2021
  4. Study completion8 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02915224
Sponsor's protocol ID
ML30133
Status last verified
Jun 2022
First submitted
23 Sep 2016
Last updated
28 Jun 2022
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Lymphocytic Leukemia, run by Hoffmann-La Roche at 11 sites in Greece.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS)\n (time frame: From screening every 6 months to Month 18 until disease progression (up to 24 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02915224.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.

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