Real-world Study of Acalabrutinib

Launched by RUIJIN HOSPITAL · Jan 9, 2025

Keywords

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Gender

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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.