Real-world Study of Acalabrutinib

A Prospective, National, Multi-center, Observational Real-world Study of Acalabrutinib in Chinese MCL/CLL Patients (RESA)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: CLL; MCL

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Chinese MCL and CLL patients treated with acalabrutinib

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
MCL; Chinese patients with MCL treated with acalabrutinib
CLL; Chinese patients with CLL treated with acalabrutinib

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The percentage of patients with AEs, SAEs (safety)	The percentage of patients with AEs, SAEs, will be summarized by System Organ Class and preferred term. The Clopper-Pearson 95% CIs around the incidence rate will also be reported.	2028/1
posology	Posology of acalabrutinib in Chinese CLL and MCL patients who received acalabrutinib according to Chinese label	2028/1

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): July 2, 2024
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: January 9, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 9, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: MCL; CLL; Acalabrutinib
• Other Study ID Numbers: ESR-22-21992

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No