Chronic Lymphocytic LeukemiaGO-CLLEARNCT03881592
Real-World Data Study Focused on Chronic Lymphocytic Leukemia (CLL) Patient Treatment Options and Their Effectiveness
An observational study of Chronic Lymphocytic Leukemia, run by Brno University Hospital at 2 sites in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 400 participants
- Where
- 2 sitesCzechia
- Study dates
- 1 Nov 2018to Sep 2019
- How long will I take part?
- 10 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients from the registry.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites, 2 recruiting
- Recruiting
University Hospital Brno, Department of Internal Medicine - Hematology and Oncology
Brno, 62500
Michael Doubek, +420605718016, doubek.michael@fnbrno.cz
Michael Doubek, A.Prof.,M.D.
- Recruiting
University Hospital Hradec Králové, Department of clinical hematology
Hradec Králové, 50005
Lukas Smolej, +420605718016, smolej@seznam.cz
Lukáš Smolej, MD, PhD
About this study
Official title: A Czech Pharmaco-epidemiological Real-World Data Study Focused on CLL Patient Treatment Options and Their Effectiveness
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.
Read the detailed description
This study will be a secondary use of data, focusing on patients treated with various treatment regimens (including obinutuzumab based regimen) used in the Czech Republic in a non-interventional, open label, national, multicenter setting. Retrospective analysis of data coming from registry database CLLEAR that capture data on clinical and treatment practices in CLL. This study is not a face to face analysis of treatment regimens. The results of this study could be used to compare with the results from other studies.
Analytical population, selection criteria and sample size
All CLL patients diagnosed, treated or followed in seven leading hematology centers in the Czech Republic since 2011 onward are included in the CLLEAR registry; there are no exclusion criteria. These centers include University Hospital (UH) Brno, General Faculty Hospital in Prague, University Hospital Hradec Kralove, University Hospital Olomouc, University Hospital Ostrava, University Hospital Plzen and Oncology Center Novy Jicin.
In this study, all patients treated with Obi-Clb, R-B and R-Clb regimens and included into the CLLEAR database will be analyzed. There no other selection criteria.
It is estimated that 400 patients will be analyzed in the study.
Primary and secondary objectives
General To assess effectiveness and disability accrual in Czech CLL patients treated with various treatment regimens in similar demographic population using available real-world data from the CLLEAR registry. The results of this study could be used to compare with the results from other studies.
Primary objective
- Patients 'profile - Patients´ demographic characteristics such as age, gender, occurrence of comorbidities, level of Cumulative Illness Rating Scale (CIRS score), renal function etc. in patients treated with various treatment regimens (Obinutuzumab+chlorambucil (Obi-Clb), rituximab+chlorambucil (R-Clb), rituximab+bendamustin (R-B)).
- Effectiveness of the treatment regimens (Obi-Clb, R-Clb, R-B) in patients with above defined demographic characteristics based on measured parameters as indication/direct correlation of effectiveness - overall response rate (ORR), complete response (CR), Progression-free Survival (PFS), Minimal Residual Disease (MRD) negativity.
Secondary objectives
The secondary objectives of this study are as follows:
- The frequency (in %) of both hematologic adverse events (neutropenia, thrombocytopenia) and non-hematologic (grade ≥3 infections and Infusion Related Reaction - IRRs) in patient population.
- The frequency of comorbidities in patient population.
- The need for treatment adjustment (e.g. decreases in number of cycles) in patients.
- The percentage of adverse events (infections) in above defined patient population requiring hospitalization.
Data protection and data monitoring
All data will be analyzed from the CLLEAR registry. Personal data protection and implementation of appropriate legislation regarding personal data protection (GDPR) is dealt with within registry CLLEAR. In the database CLLEAR, there are strict rules on the protection of personal data due to Czech law.
All patients' data are anonymized. All patients have to sign informed consent. The registry was approved by multicentric ethics committee. It is an incremental data set that is updated periodically, every 6 months, and regularly validated by an independent central data manager. No monitoring of centers is performed.
Regulatory and legislative requirements
General Informed Consent is not part of this study as this study uses data from separate registry CLLEAR. Registry has its own Informed Consents. Informed consent based essentially on the data privacy clause is obtained from each patient prior to data collection into the registry CLLEAR as two original documents signed by the patient. One original Informed Consent Form (ICF) is filed with the patient´s documentation in the clinical center and the second original ICF is given to the patient.
This is a non-interventional post-registration study that must follow all local law or regulations and medical practice. Local legislative requirements of the Czech Republic will be applied.
Quality assurance and control
The project will be carried in accordance with IBA (Institute of Biostatistics and Analyses) internal quality management system and procedures (established Quality Management System according to the norm of the International Organization for Standardization - ISO 9001:2012 including the quality manual; system Information technology according to ISO/IEC 20000-1:2012).
Study data analysis
This study is secondary data use, observational, with data and analysis gathered as indicated in the following sections.
The following general /baseline and therapeutic characteristics and measures will be collected: age, gender, comorbidities, level of CIRS score, renal function (e.g. creatinine level), side effects hematology related and unrelated and the need for hospitalization, number of chemotherapeutic cycles, response to treatment (i.e. complete or partial remission), occurrence of progression and presence of minimal residual disease (MRD).
- Conditions
- Chronic Lymphocytic Leukemia
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
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.
Measured: From the treatment administration until the disease progression, death or date of data export (up to 96 months)
Complete response (CR) rate
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
Measured: From the treatment administration up to approximately 2 months after the end of the analyzed treatment
Partial response (PR) rate
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
Measured: From the treatment administration up to approximately 2 months after the end of the analyzed treatment
Overall response (ORR) rate
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.
Measured: From the treatment administration up to approximately 2 months after the end of the analyzed treatment
Minimal residual disease (MRD) negativity rate
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).
Measured: From the treatment administration up to 12 months after the end of the analyzed treatment
Secondary outcomes (4)
Frequency of patients with hematologic adverse events, non-hematologic adverse events and infusion-related reactions
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.
Measured: From the treatment administration until the end of the analyzed treatment (up to 96 months)
Frequency of patients with a hematologic or non-hematologic adverse event or an infusion-related reaction that needed hospitalization
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.
Measured: From the treatment administration until the end of the analyzed treatment (up to 96 months)
Frequency of comorbidities occurring before or during the treatment
Comorbidities are defined as additional conditions co-occurring with chronic lymphocytic leukaemia. They were collected before and during the analyzed treatment.
Measured: From the date of birth of patients until the end of the analyzed treatment (up to 96 months)
Frequency of patients with a decrease in the number of cycles and with an increase in the number of cycles
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.
Measured: Treatment administration (6 cycles, it means 6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start1 Nov 2018
- Primary completionJun 2019 (estimated)
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lymphocytic LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Cohort
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Michael Doubek, M.D., Ph.D, Brno University Hospital
- Investigators
- Michael Doubek, Prof,MD,PhD, Principal investigator, The Czech CLL Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03881592
- Sponsor's protocol ID
- ML41010
- Acronym
- GO-CLLEAR
- Status last verified
- Mar 2019
- First submitted
- 3 Mar 2019
- Last updated
- 19 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Czech Pharmaco-epidemiological Real-World Data Study Focused on CLL Patient Treatment Options and Their Effectiveness
- ClinicalTrials.gov ID
- NCT03881592
- Acronym / sponsor ID
- GO-CLLEAR / ML41010
- Conditions
- Chronic Lymphocytic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 19 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a secondary use of data, focusing on patients treated with various treatment regimens (including obinutuzumab based regimen) used in the Czech Republic in a non-interventional, open label, national, multicenter setting. Retrospective analysis of data coming from registry database CLLEAR that capture data on clinical and treatment practices in CLL. This study is not a face to face analysis of treatment regimens. The results of this study could be used to compare with the results from other studies.
Analytical population, selection criteria and sample size
All CLL patients diagnosed, treated or followed in seven leading hematology centers in the Czech Republic since 2011 onward are included in the CLLEAR registry; there are no exclusion criteria. These centers include University Hospital (UH) Brno, General Faculty Hospital in Prague, University Hospital Hradec Kralove, University Hospital Olomouc, University Hospital Ostrava, University Hospital Plzen and Oncology Center Novy Jicin.
In this study, all patients treated with Obi-Clb, R-B and R-Clb regimens and included into the CLLEAR database will be analyzed. There no other selection criteria.
It is estimated that 400 patients will be analyzed in the study.
Primary and secondary objectives
General To assess effectiveness and disability accrual in Czech CLL patients treated with various treatment regimens in similar demographic population using available real-world data from the CLLEAR registry. The results of this study could be used to compare with the results from other studies.
Primary objective
- Patients 'profile - Patients´ demographic characteristics such as age, gender, occurrence of comorbidities, level of Cumulative Illness Rating Scale (CIRS score), renal function etc. in patients treated with various treatment regimens (Obinutuzumab+chlorambucil (Obi-Clb), rituximab+chlorambucil (R-Clb), rituximab+bendamustin (R-B)).
- Effectiveness of the treatment regimens (Obi-Clb, R-Clb, R-B) in patients with above defined demographic characteristics based on measured parameters as indication/direct correlation of effectiveness - overall response rate (ORR), complete response (CR), Progression-free Survival (PFS), Minimal Residual Disease (MRD) negativity.
Secondary objectives
The secondary objectives of this study are as follows:
- The frequency (in %) of both hematologic adverse events (neutropenia, thrombocytopenia) and non-hematologic (grade ≥3 infections and Infusion Related Reaction - IRRs) in patient population.
- The frequency of comorbidities in patient population.
- The need for treatment adjustment (e.g. decreases in number of cycles) in patients.
- The percentage of adverse events (infections) in above defined patient population requiring hospitalization.
Data protection and data monitoring
All data will be analyzed from the CLLEAR registry. Personal data protection and implementation of appropriate legislation regarding personal data protection (GDPR) is dealt with within registry CLLEAR. In the database CLLEAR, there are strict rules on the protection of personal data due to Czech law.
All patients' data are anonymized. All patients have to sign informed consent. The registry was approved by multicentric ethics committee. It is an incremental data set that is updated periodically, every 6 months, and regularly validated by an independent central data manager. No monitoring of centers is performed.
Regulatory and legislative requirements
General Informed Consent is not part of this study as this study uses data from separate registry CLLEAR. Registry has its own Informed Consents. Informed consent based essentially on the data privacy clause is obtained from each patient prior to data collection into the registry CLLEAR as two original documents signed by the patient. One original Informed Consent Form (ICF) is filed with the patient´s documentation in the clinical center and the second original ICF is given to the patient.
This is a non-interventional post-registration study that must follow all local law or regulations and medical practice. Local legislative requirements of the Czech Republic will be applied.
Quality assurance and control
The project will be carried in accordance with IBA (Institute of Biostatistics and Analyses) internal quality management system and procedures (established Quality Management System according to the norm of the International Organization for Standardization - ISO 9001:2012 including the quality manual; system Information technology according to ISO/IEC 20000-1:2012).
Study data analysis
This study is secondary data use, observational, with data and analysis gathered as indicated in the following sections.
The following general /baseline and therapeutic characteristics and measures will be collected: age, gender, comorbidities, level of CIRS score, renal function (e.g. creatinine level), side effects hematology related and unrelated and the need for hospitalization, number of chemotherapeutic cycles, response to treatment (i.e. complete or partial remission), occurrence of progression and presence of minimal residual disease (MRD).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients from the registry.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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
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.
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).
4 secondary outcomes
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2019.
- Czech leukemia study group for life - website with the link to the CLLEAR registryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
University Hospital Brno, Department of Internal Medicine - Hematology and Oncology
Brno, Czechia
University Hospital Hradec Králové, Department of clinical hematology
Hradec Králové, Czechia
Michael Doubek, Prof,MD,PhD principal investigator
The Czech CLL Study Group
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Lymphocytic Leukemia, run by Brno University Hospital at 2 sites in Czechia.
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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: From the treatment administration until the disease progression, death or date of data export (up to 96 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2019.