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Enrolling by Invitation

NCT Number: NCT06767891

Real-world Study of Acalabrutinib

The primary purpose of this study was to describe acotinib treatment patterns among Chinese patients with CLL and MCL who received acotinib according to the label. Secondary objectives include: 1) To evaluate the safety of acotinib in Chinese patients with CLL and MCL who received acotinib according to the label. 2) Evaluate the dose of acotinib in Chinese patients with CLL and MCL who receive acotinib according to the label. 3) Describe the baseline clinical and demographic characteristics of patients with CLL and MCL who received acotinib according to the label. The exploratory objectives of the study include: 1) To describe the real-world overall survival (rwOS) of Chinese CLL and MCL patients treated with acotinib according to the label. 2) Describe the real-world clinical progression-free survival (rwPFS) of Chinese CLL and MCL patients who received acotinib according to the label. 3) Describe the real-world response rate (rwRR) in Chinese CLL and MCL patients who received acotinib according to the label.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 1: Patients should be ≥18 years old at diagnosis
  • 2: Diagnosed as MCL or CLL who have received at least one prior therapy and CLL patients should be enrolled after the approval of NMPA (according to Chinese label)
  • 3: Eligible for acalabrutinib treatment assessed by investigators (physician's evaluation) in clinical practice
  • 4: Patient/legal guardian must be able to read, understand, and sign the informed consent form (ICF)

Exclusion criteria

  • 1: Ineligible for acalabrutinib treatment assessed by investigators (physician's evaluation)
  • 2: Progression after accepting other BTKi treatment before use of acalabrutinib
  • 3: Concurrent participation in another interventional clinical study
  • 4: Females of childbearing potential must practice highly effective contraception during treatment of acalabrutinib, and for at least 1 week after the last dose of acalabrutinib, and have a negative urine or serum pregnancy test ≤ 7 days before the first dose of study drug(s).
  • 5: No requirement to use contraception for male subjects treated with acalabrutinib. a. A sterile male is considered a highly effective contraception method for female patients. b. Males with known "low sperm counts" (consistent with "sub-fertility") are not to be considered sterile for purposes of this study.

Treatment and study plan

Primary outcomes

  1. treatment patterns

    Time frame: 2028/1

    Acalabrutinib treatment pattern will be summarized by the percentage of patients with acalabrutinib monotherapy and combo-therapies. Among patients with acalabrutinib combo-therapy, the frequency and percentage of patients in each categories (e.g. chemo, anti-CD20mAb, BCL2i, immunomodulator, etc.) will also be summarized. The Clopper-Pearson 95% confidence intervals (CIs) will also be presented.

Secondary outcomes

  1. The percentage of patients with AEs, SAEs (safety)

    Time frame: 2028/1

    The percentage of patients with AEs, SAEs, will be summarized by System Organ Class and preferred term. The Clopper-Pearson 95% CIs around the incidence rate will also be reported.

  2. posology

    Time frame: 2028/1

    Posology of acalabrutinib in Chinese CLL and MCL patients who received acalabrutinib according to Chinese label

Sponsors and collaborators

Lead sponsor

Ruijin Hospital

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

A Prospective, National, Multi-center, Observational Real-world Study of Acalabrutinib in Chinese MCL/CLL Patients (RESA)

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Jan 10, 2025
Registry last updated
Jan 10, 2025

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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