Real-world Study of Acalabrutinib

NCT06767891 | Enrolling By Invitation

• 1 other identifier: ESR-22-21992
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

MCL; CLL

Keywords

Acalabrutinib; MCL; CLL

Outcome Measures

Primary Outcomes (1)

• treatment patterns

  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.

  2028/1

Secondary Outcomes (2)

• The percentage of patients with AEs, SAEs (safety)

  2028/1

• posology

  2028/1

Study Arms (2)

MCL

Chinese patients with MCL treated with acalabrutinib

CLL

Chinese patients with CLL treated with acalabrutinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chinese MCL and CLL patients treated with acalabrutinib

You may qualify if:

• : Patients should be ≥18 years old at diagnosis
• : 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)
• : Eligible for acalabrutinib treatment assessed by investigators (physician's evaluation) in clinical practice
• : Patient/legal guardian must be able to read, understand, and sign the informed consent form (ICF)

You may not qualify if:

• : Ineligible for acalabrutinib treatment assessed by investigators (physician's evaluation)
• : Progression after accepting other BTKi treatment before use of acalabrutinib
• : Concurrent participation in another interventional clinical study
• : 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).
• : 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: January 10, 2025
• Study Start: July 2, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): January 30, 2028
• Last Updated: January 10, 2025

Record last verified: 2024-08

Locations

CN (1)