Real-world Study of Acalabrutinib
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: MCL, CLL. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective, National, Multi-center, Observational Real-world Study of Acalabrutinib in Chinese MCL/CLL Patients (RESA)
Overview
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.
Primary outcome measures
- treatment patterns [Time frame: 2028/1]
Secondary outcome measures (2)
- The percentage of patients with AEs, SAEs (safety) [Time frame: 2028/1]
- posology [Time frame: 2028/1]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai
Identifiers
NCT: NCT06767891 · ESR-22-21992