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Real-world Study of Acalabrutinib

Enrolling By InvitationN/A

Sponsor: Ruijin Hospital

Conditions: Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Countries: China

The primary purpose of this study is to describe acotinib treatment patterns in Chinese patients with CLL/SLL and MCL who received acotinib according to the label. Secondary objectives include: 1) To evaluate the safety of acotinib in Chinese patients with CLL/SLL and MCL who received acotinib according to the label. 2) To evaluate the dose of acotinib in Chinese patients with CLL/SLL and MCL who received acotinib according to the label. 3) To describe the baseline clinical and demographic characteristics of Chinese patients with CLL/SLL 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 patients with CLL/SLL and MCL who received acotinib according to the label. 2) To describe the real-world clinical progression-free survival (rwPFS) of Chinese patients with CLL/SLL and MCL who received acotinib according to the label. 3) To describe the real-world response rate (rwRR) of Chinese patients with CLL/SLL and MCL who received acotinib according to the label. 4) To describe the real-world measurable residual disease (MRD) negativity rate in Chinese patients with CLL/SLL and MCL who received acotinib according to the label.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* 1: Patients should be ≥18 years old at diagnosis
* 2: Diagnosed as MCL who have received at least one prior therapy, OR diagnosed as CLL/SLL who are treatment-naïve or have received at least one prior therapy (per the local prescribing label for acalabrutinib)
* 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.

Locations (1)

Shanghai, Shanghai Municipality, China