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Real-World Data Study Focused on Chronic Lymphocytic Leukemia (CLL) Patient Treatment Options and Their Effectiveness (GO-CLLEAR)

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ClinicalTrials.gov Identifier: NCT03881592
Recruitment Status : Recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Prof. Michael Doubek, M.D., Ph.D, Brno University Hospital

Brief Summary:
This study will be a secondary use of data, focusing on patients treated with combination therapy Obi-Clb, R-Clb or R-B, in a non-interventional, open label, national, multicenter setting. Retrospective analysis of data coming from registry database CLLEAR (www.leukemia-cell.org )that capture data on clinical and treatment practices in CLL. Data will be retrospectively analyzed.

Condition or disease
Chronic Lymphocytic Leukemia

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 10 Years
Official Title: A Czech Pharmaco-epidemiological Real-World Data Study Focused on CLL Patient Treatment Options and Their Effectiveness
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : September 2019


Group/Cohort
R-Clb patients
Patients treated with the combination of Rituximab + chlorambucil
R-B patients
Patients treated with the combination of Rituximab + bendamustine
Obi-Clb patients
Patients treated with the combination of Obinutuzumab + chlorambucil



Primary Outcome Measures :
  1. Progression-free survival (PFS) [ Time Frame: From the treatment administration until the disease progression, death or date of data export (up to 96 months) ]
    PFS is defined as the number of months from the start of treatment with analyzed therapies (Obi-Clb, R-Clb, BR) until the first documentation of disease progression or death due to any cause, whichever occurred first. Kaplan-Meier method was used for evaluation.

  2. Complete response (CR) rate [ Time Frame: From the treatment administration up to approximately 2 months after the end of the analyzed treatment ]
    Complete response (remission) was assessed by using the National Cancer Institute - Working Group guidelines on CLL. It is the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. For CR definition see Hallek et al. Blood 2008 111:5446-5456; doi: https://doi.org/10.1182/blood-2007-06-093906

  3. Partial response (PR) rate [ Time Frame: From the treatment administration up to approximately 2 months after the end of the analyzed treatment ]
    Partial response (remission) was assessed by using the National Cancer Institute - Working Group guidelines on CLL. For PR definition see Hallek et al. Blood 2008 111:5446-5456; doi: https://doi.org/10.1182/blood-2007-06-093906

  4. Overall response (ORR) rate [ Time Frame: From the treatment administration up to approximately 2 months after the end of the analyzed treatment ]
    ORR is defined as the proportion of participants with complete remission (CR) or partial remission (PR) out of the total number of participants. Responses were assessed by using National Cancer Institute - Working Group guidelines on CLL.

  5. Minimal residual disease (MRD) negativity rate [ Time Frame: From the treatment administration up to 12 months after the end of the analyzed treatment ]
    The patients who achieved a CR and did not have detectable MRD in the bone marrow by four-color flow cytometry (<0.1% of cells).


Secondary Outcome Measures :
  1. Frequency of patients with hematologic adverse events, non-hematologic adverse events and infusion-related reactions [ Time Frame: From the treatment administration until the end of the analyzed treatment (up to 96 months) ]
    Adverse events (hematologic, non-hematologic and infusion-related reactions) were collected from the start of study treatment until the end of the treatment or end of the study. Besides the frequency of patients with a hematologic adverse event, the occurrence of neutropenia, thrombocytopenia and anaemia of different grades is presented. Beside the frequency of patients with a non-hematologic adverse event, the frequency of patients with an infection is presented.

  2. Frequency of patients with a hematologic or non-hematologic adverse event or an infusion-related reaction that needed hospitalization [ Time Frame: From the treatment administration until the end of the analyzed treatment (up to 96 months) ]
    Adverse events (hematologic, non-hematologic and infusion-related reactions) were collected from the start of study treatment until the end of the treatment or end of the study. Out of patients with at least one adverse event, the frequency of patients requiring hospitalization ir observed.

  3. Frequency of comorbidities occurring before or during the treatment [ Time Frame: From the date of birth of patients until the end of the analyzed treatment (up to 96 months) ]
    Comorbidities are defined as additional conditions co-occurring with chronic lymphocytic leukaemia. They were collected before and during the analyzed treatment.

  4. Frequency of patients with a decrease in the number of cycles and with an increase in the number of cycles [ Time Frame: Treatment administration (6 cycles, it means 6 months) ]
    A decrease in the number of cycles is when the administered number of cycles is lower than 6 (i.e. standard number of cycles) and it is considered as a treatment adjustment. An increase in the number of cycles is when the administered number of cycles is higher than 6 (i.e. standard number of cycles) and it is considered as a treatment adjustment.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients from the registry.
Criteria

Inclusion Criteria:

  • Diagnosis of Chronic Lymphocytic Leukemia
  • Patients treated with Bendamustin plus Rituximab, Rituximab plus Chlorambucil or Obinutuzumab plus Chlorambucil regimens as first line of treatment
  • Provision of informed consent for recording of patient data in the CLLEAR registry

Exclusion Criteria:

  • All untreated patients
  • Patients with both Rituximab plus Chlorambucil and Bendamustin plus Rituximab or Obinutuzumab plus Chlorambucil in second or subsequent lines
  • Patients with prednisone alongside analysed regimens in the first line of treatment
  • Patients with RCD (Rituximab, Cyclophosphamide, Dexamethasone) or FCR (Fludarabine, Cyclophosphamide, Rituximab) or other regimen before analysed regimens within the first line of treatment
  • Patients with R-Dex (Rituximab and Dexamethasone) cycles in between R-Clb cycles

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): NCT03881592


Locations
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Czechia
University Hospital Brno, Department of Internal Medicine - Hematology and Oncology Recruiting
Brno, Czechia, 62500
Contact: Michael Doubek    +420605718016    doubek.michael@fnbrno.cz   
Principal Investigator: Michael Doubek, A.Prof.,M.D.         
University Hospital Hradec Králové, Department of clinical hematology Recruiting
Hradec Králové, Czechia, 50005
Contact: Lukas Smolej    +420605718016    smolej@seznam.cz   
Principal Investigator: Lukáš Smolej, MD, PhD         
Sponsors and Collaborators
Brno University Hospital
Investigators
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Principal Investigator: Michael Doubek, Prof,MD,PhD The Czech CLL Study Group

Additional Information:
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Responsible Party: Prof. Michael Doubek, M.D., Ph.D, Head of the Czech CLL Study Group, Brno University Hospital
ClinicalTrials.gov Identifier: NCT03881592     History of Changes
Other Study ID Numbers: ML41010
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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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