Chronic Lymphocytic LeukemiaNCT03633045
Observational Study of Ibrutinib Use in CLL
An observational study of Chronic Lymphocytic Leukemia, run by Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
Trial summary
IB-RU-SCOPE is a "routine-clinical practice" oriented cohort observational study of ibrutinib efficacy and safety in approx. 70 patients with chronic lymphocytic leukemia in the Russian Federation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lymphocytic Leukemia
- How many people
- 70 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2018to 30 Apr 2022
- 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: Males and females with confirmed diagnosis of CLL treated with Ibrutinib
Who may be able to join
- Age older than 18 years.
- Diagnosis of chronic lymphocytic leukemia, established according to iwCLL criteria (Hallek et al., 2018).
- Presence of indications for initiating treatment as listed in iwCLL guidelines (Hallek et al., 2018) before start of ibrutinib therapy.
- Treatment with ibrutinib per instructions for medical use of the drug, approved in the Russian Federation, is planned or this therapy has been started within 7 days before enrolment in the study (date of signing of informed consent). Simultaneously, the patient has not received ibrutinib as one of the previous lines of treatment.
- Informed consent signed by the patient.
Who cannot join
- 1. Presence of contraindications for the use of ibrutinib in accordance with the instructions, approved in the Russian Federation for the medical use of the drug, namely:
- known hypersensitivity to ibrutinib (e.g. with anaphylactic and anaphylactoid reactions);
- pregnancy and the period of breastfeeding;
- age under 18 years;
- severe renal dysfunction (creatinine clearance <30 mL/min), incl. need for hemodialysis;
- severe liver dysfunction (Child-Pugh class C);
- concomitant use with strong inducers of the isoenzyme CYP3A (e.g., carbamazepine, rifampicin, phenytoin and drugs, containing Hypericum perforatum extract);
- concomitant use with warfarin, other vitamin K antagonists, fish oil and vitamin E preparations.
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Almazov FMRC
Saint Petersburg, 197341
Andrey Zaritskey, MD, PhD, 0078127023765 ext. 005193
About this study
Official title: Analysis of Ibrutinib Efficacy and Safety in the Treatment of Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice
IB-RU-SCOPE is a "routine-clinical practice" oriented cohort observational study of ibrutinib efficacy and safety in approx. 70 patients with chronic lymphocytic leukemia in the Russian Federation
Read the detailed description
Ibrutinib is approved in Russia for treatment of CLL patients both in first line and in relapsed/refractory setting. There is a discrepancy in reported ibrutinib toxicity profile, efficacy and tolerability between registrational clinical trials and observational studies, which to some extent may be explained by patient selection in the former. IB-RU-SCOPE is a first "routine-clinical practice" oriented cohort observational study of ibrutinib in CLL in Russia. The study is designed to include all previously untreated and relapsed/refractory CLL patients older than 18 years with active disease, who have recently started or are about to start ibrutinib (both as monotherapy and in combination), and to follow them to a minimum of 18 and a maximum of 36 months. The study is being conducted in approx. 10 Russian hematological centers and aims to include approx. 70 CLL patients.
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CLL, chronic lymphocytic leukemia, ibrutinib
- Medical subject headings
- Leukemia, Lymphocytic, Chronic, B-Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of adverse events (including serious adverse events)
In order to evaluate ibrutinib toxicity, all adverse events (AEs), which will occur in study patients, will be collected and analyzed. CTCAE v4.03 criteria and iwCLL criteria will be used for grading of non-hematologic and hematologic AEs, respectively. Frequencies of AEs of all grades will be calculated and reported.
Measured: 3 years
Average duration of treatment with ibrutinib
Time from the first dose of ibrutinib to treatment discontinuation (e.g. due to AEs or CLL progression) will be measured in all study patients. Mean value will be then calculated and reported. This will provide a context, necessary for interpetation of other results (such as toxicity and efficacy measures).
results (such as toxicity and efficacy measures).
Measured: 3 years
Proportion of patients requiring dose reduction and/or discontinuation of therapy due to causes not related to CLL progression.
In order to evaluate tolerability of ibrutinib in CLL patients in routine clinical practice, all cases of ibrutinib dose reduction and/or drug discontinuation due to causes not related to CLL progression will be collected and analyzed. Proportion of patients, not tolerating full dose of ibrutinib will be then calculated and reported.
Measured: 3 years
Dynamics of QoL indicators assessed by EORTC QLQ-C30 (version 3.0) questionnaire during treatment
Patients will complete EORTC QLQ-C30 (version 3.0) questionnaires every 3 months during the sudy. Data from questionnaires will be subsequently extracted as numerical values and analyzed according to recommended protocol to estimate changes in patient's quality of life (QoL) during treatment. As a result, either improvement, decline or no change in QoL will be shown
Measured: 3 yers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2018
- Study start1 Sep 2018
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Apr 2022 (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
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Conrady Alexandra, Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03633045
- Sponsor's protocol ID
- IB-RU-SCOPE
- Status last verified
- Feb 2020
- First submitted
- 20 Jul 2018
- Last updated
- 10 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- 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 10 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Ibrutinib Efficacy and Safety in the Treatment of Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT03633045
- Acronym / sponsor ID
- IB-RU-SCOPE
- Conditions
- Chronic Lymphocytic Leukemia
- Keywords
- CLL, chronic lymphocytic leukemia, ibrutinib
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of HealthUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 16 Aug 2018 (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.
IB-RU-SCOPE is a "routine-clinical practice" oriented cohort observational study of ibrutinib efficacy and safety in approx. 70 patients with chronic lymphocytic leukemia in the Russian Federation
Detailed description
Ibrutinib is approved in Russia for treatment of CLL patients both in first line and in relapsed/refractory setting. There is a discrepancy in reported ibrutinib toxicity profile, efficacy and tolerability between registrational clinical trials and observational studies, which to some extent may be explained by patient selection in the former. IB-RU-SCOPE is a first "routine-clinical practice" oriented cohort observational study of ibrutinib in CLL in Russia. The study is designed to include all previously untreated and relapsed/refractory CLL patients older than 18 years with active disease, who have recently started or are about to start ibrutinib (both as monotherapy and in combination), and to follow them to a minimum of 18 and a maximum of 36 months. The study is being conducted in approx. 10 Russian hematological centers and aims to include approx. 70 CLL patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Males and females with confirmed diagnosis of CLL treated with Ibrutinib
Key inclusion criteria (5 listed)
- Age older than 18 years.
- Diagnosis of chronic lymphocytic leukemia, established according to iwCLL criteria (Hallek et al., 2018).
- Presence of indications for initiating treatment as listed in iwCLL guidelines (Hallek et al., 2018) before start of ibrutinib therapy.
- Treatment with ibrutinib per instructions for medical use of the drug, approved in the Russian Federation, is planned or this therapy has been started within 7 days before enrolment in the study (date of signing of informed consent). Simultaneously, the patient has not received ibrutinib as one of the previous lines of treatment.
- Informed consent signed by the patient.
Key exclusion criteria (8 listed)
- 1. Presence of contraindications for the use of ibrutinib in accordance with the instructions, approved in the Russian Federation for the medical use of the drug, namely:
- known hypersensitivity to ibrutinib (e.g. with anaphylactic and anaphylactoid reactions);
- pregnancy and the period of breastfeeding;
- age under 18 years;
- severe renal dysfunction (creatinine clearance <30 mL/min), incl. need for hemodialysis;
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
Frequency of adverse events (including serious adverse events)
Time frame: 3 years
In order to evaluate ibrutinib toxicity, all adverse events (AEs), which will occur in study patients, will be collected and analyzed. CTCAE v4.03 criteria and iwCLL criteria will be used for grading of non-hematologic and hematologic AEs, respectively. Frequencies of AEs of all grades will be calculated and reported.
Average duration of treatment with ibrutinib
Time frame: 3 years
Time from the first dose of ibrutinib to treatment discontinuation (e.g. due to AEs or CLL progression) will be measured in all study patients. Mean value will be then calculated and reported. This will provide a context, necessary for interpetation of other results (such as toxicity and efficacy measures). results (such as toxicity and efficacy measures).
Proportion of patients requiring dose reduction and/or discontinuation of therapy due to causes not related to CLL progression.
Time frame: 3 years
In order to evaluate tolerability of ibrutinib in CLL patients in routine clinical practice, all cases of ibrutinib dose reduction and/or drug discontinuation due to causes not related to CLL progression will be collected and analyzed. Proportion of patients, not tolerating full dose of ibrutinib will be then calculated and reported.
Dynamics of QoL indicators assessed by EORTC QLQ-C30 (version 3.0) questionnaire during treatment
Time frame: 3 yers
Patients will complete EORTC QLQ-C30 (version 3.0) questionnaires every 3 months during the sudy. Data from questionnaires will be subsequently extracted as numerical values and analyzed according to recommended protocol to estimate changes in patient's quality of life (QoL) during treatment. As a result, either improvement, decline or no change in QoL will be shown
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2020.
- 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.
1 site 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 Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health at 1 site in Russia.
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 5 inclusion and 8 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 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. 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?
Contact Andrey Zaritskey, MD, PhD (0078127023765 ext. 005192, ibruscope@ya.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of adverse events (including serious adverse events) (time frame: 3 years). The study lists 4 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 10 Feb 2020.