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Real-world Study of Acalabrutinib

Study acronym: RESA
StatusEnrolling by Invitation
PhaseNot specified
Started2024-07-02
View on ClinicalTrials.gov ↗
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.

Amendment history 3 changes detected by DataLookout

2026-09-09
notable
Enrollment reduced: 200 → 160 participants
2026-09-09
critical
Primary completion pushed: 2026-07-30 → 2029-10
2026-09-09
minor
Completion pushed: 2028-01-30 → 2029-11
Trial Details
NCT Number NCT06767891
Lead Sponsor Ruijin Hospital
Collaborators: AstraZeneca
Conditions Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
Enrollment 160 participants
Start Date 2024-07-02
Primary Completion 2029-10 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-09-08