Clinical trial NCT06767891: Real-world Study of Acalabrutinib
Official title: A Prospective, National, Multi-center, Observational Real-world Study of Acalabrutinib in Chinese MCL/CLL Patients (RESA)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: MCL
CLL
Keywords: Acalabrutinib
MCL
CLL
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2025-01-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chinese MCL and CLL patients treated with acalabrutinib

Brief summary: 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.


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.

Primary outcomes:
measure: treatment patterns
timeFrame: 2028/1
Secondary outcomes:
measure: The percentage of patients with AEs, SAEs (safety)
timeFrame: 2028/1
measure: posology
timeFrame: 2028/1
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: