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NCT Number: NCT06170671

REAl-world Outcomes in CHronic Lymphocytic Leukemia Patients Receiving Acalabrutinib in Romania

Acalabrutinib received European Medicines Agency approval on November 2020 for for CLL adult patients, either as monotherapy or in combination with obinutuzumab, in previously untreated patients or as monotherapy in patients who have received at least one prior therapy and is reimbursed in Romania since January 2023. In the absence of disease registries or national datasets patient population receiving acalabrutinib in real life setting is not well characterized. The study aims to look into this population outcomes and clinical characteristics having as primary objective time to discontinuation by line of treatment and secondary objectives: reasons for discontinuation, effectiveness of acalabrutinib in real-life practice, baseline clinical and demographic characteristics, treatment patterns and major determinants of treatment discontinuation. The study will retrospectively collect longitudinal data from 250 patients at national level,at pre-defined timepoints for 3 years, from 2 sequential cohorts,1st one enrolled on December 2023 and 2nd one enrolled in December 2024 based on the acalabrutinib start year..

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Piteşti, Argeş, Romania

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (age >18 years) with confirmed diagnosis of chronic lymphocytic leukemia/ small lymphocytic lymphoma
  • Patients initiating front-line or subsequent treatment with acalabrutinib between January 2023 and Dec 2024 according to the national therapeutic protocol
  • Patients able and willing to provide their written informed consent to participate in the study

Exclusion criteria

  • The treatment with acalabrutinib was initiated during an interventional clinical trial
  • Enrolment performed less than 30 days from start of treatment with acalabrutinib

Treatment and study plan

Non interventional study

Drug

CLL patients routinely initiated on acalabrutinib by their physician between January 2023 -December 2024. Retrospective secondary data collection

Primary outcomes

  1. Time to acalabrutinib treatment discontinuation (TTD)

    Time frame: Once a year during the 3 years of follow up since acalabrutinib start

    TTD is defined as the time between the first day of acalabrutinib treatment and the day that acalabrutinib is definitely stopped for whatever reason or death

Secondary outcomes

  1. Reasons for treatment discontinuation

    Time frame: Once a year until end of the study ( 3 years from start of acalabrutinib)

    Reasons for acalabrutinib interruption

  2. effectiveness of acalabrutinib

    Time frame: Once a year until end of the study ( 3 years from start of acalabrutinib)

    Real world progression free survival (rwPFS) is defined as the time from initiation of acalabrutinib therapy (index date) until earliest record of disease progression determined by physicians' assessment (clinical or radiological progression or start of a new line therapy),or death

  3. Baseline clinical and demographic characteristics

    Time frame: At first data collection for cohort 1 in December 2023 and at first data collection for cohort 2 in December 2024

    Demographic characteristics (age,gender, BMI) and disease characteristics (age at diagnosis, staging, symptoms, active disease criteria,previous treatment

  4. acalabrutinib interruption

    Time frame: Once a year until end of the study (3 years from the start of acalabrutinib)

    Percentage of patients with acalabrutinib interruption

  5. time to interruption

    Time frame: Once a year until end of the study ( 3 years from start of acalabrutinib)

    Time between first day of acalabrutinib and the day of first interruption of acalabrutinib

  6. duration of interruption

    Time frame: once a year until the end of the study ( 3 years from acalabrutinib start)

    Time between the first day of acalabrutinib interruption and the first day of acalabrutinib restart

  7. acalabrutinib dose changes

    Time frame: once a year until the end of the study ( 3 years from acalabrutinib start)

    Percentage of patients with dose changes

  8. Reasons of acalabrutinib dose changes

    Time frame: once a year until the end of the study ( 3 years from acalabrutinib start)

    Reasons of acalabrutinib dose changes (all including adverse events)

  9. Major determinant of treatment discontinuation

    Time frame: once a year until end of the study( 3 years from acalabrutinib start)

    a multivariate analysis (Cox model) will be performed to study correlation between TTD and patient characteristics at baseline.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Observational, Secondary Data Collection Study to Describe Acalabrutinib Treatment Outcomes in Chronic Lymphocytic Leukemia Patients in Real-life Setting in Romania

Acronym: REACH

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Dec 14, 2023
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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