Clinical trial NCT03633045: Observational Study of Ibrutinib Use in CLL
Official title: Analysis of Ibrutinib Efficacy and Safety in the Treatment of Chronic Lymphocytic Leukemia Patients in Routine Clinical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Lymphocytic Leukemia
Keywords: CLL, chronic lymphocytic leukemia, ibrutinib
Lead sponsor: Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
Sponsor class: OTHER
First posted: 2018-08-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Males and females with confirmed diagnosis of CLL treated with Ibrutinib

Brief 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

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.

Eligibility criteria: Inclusion Criteria:

1. Age older than 18 years.
2. Diagnosis of chronic lymphocytic leukemia, established according to iwCLL criteria (Hallek et al., 2018).
3. Presence of indications for initiating treatment as listed in iwCLL guidelines (Hallek et al., 2018) before start of ibrutinib therapy.
4. 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.
5. Informed consent signed by the patient.

Exclusion Criteria:

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.

Primary outcomes:
measure: Frequency of adverse events (including serious adverse events)
timeFrame: 3 years
measure: Average duration of treatment with ibrutinib
timeFrame: 3 years
measure: Proportion of patients requiring dose reduction and/or discontinuation of therapy due to causes not related to CLL progression.
timeFrame: 3 years
measure: Dynamics of QoL indicators assessed by EORTC QLQ-C30 (version 3.0) questionnaire during treatment
timeFrame: 3 yers
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Almazov FMRC
Study officials:
References: