Observational Study of Ibrutinib Use in CLL

NCT03633045 | Unknown

• 1 other identifier: IB-RU-SCOPE
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Lymphocytic Leukemia

Keywords

CLL, chronic lymphocytic leukemia, ibrutinib

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  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

  3 yers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Males and females with confirmed diagnosis of CLL treated with Ibrutinib

You may qualify if:

• 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.

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health: lead

Study Sites (1)

Almazov FMRC

Saint Petersburg, 197341, Russia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood. Biobanking of whole blood specimens, collected for routine tests (if available, under separate biobanking informed consent)

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andrey Zaritskey, MD, PhD

CONTACT

0078127023765; ibruscope@ya.ru

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy General Director

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 16, 2018
• Study Start: September 1, 2018
• Primary Completion: September 30, 2021
• Study Completion: April 30, 2022
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)