An observational study in Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), sponsored by Ruijin Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Ruijin Hospital · Observational
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.
Acotinib is a highly selective, irreversible second-generation Bruton tyrosine kinase (BTK) inhibitor. NMPA approved acotinib in March 2023 for R/R MCL (≥1 prior therapy), in August 2023 for R/R CLL/SLL (≥1 prior therapy), and in March 2025 for first-line treatment of treatment-naïve CLL.
The phase III ChangE study (Qiu et al., 2024 ASH Poster 642) demonstrated the efficacy of acotinib in Asian patients with treatment-naïve CLL: 155 patients randomized 1:1 to acotinib (100 mg orally twice daily, continuous) or chlorambucil plus rituximab (6 cycles) across 44 study sites in mainland China, Taiwan (China), Vietnam, Thailand, and the Philippines; the Chinese cohort comprised 103 patients from 30 sites. At a median follow-up of 23.5 months (overall) and 18.2 months (Chinese cohort), acotinib reduced the risk of disease progression or death by 92% as assessed by blinded independent central review (HR=0.08; P\<0.0001), with median PFS not reached versus 15.5 months and a 24-month PFS rate of 92% versus 25%; no new safety signals were identified.
Despite these pivotal data, real-world evidence on acotinib in routine Chinese clinical practice-including treatment patterns, dose modifications, long-term safety, effectiveness in real-world populations, and minimal residual disease (MRD) outcomes-remains limited.
The RESA study is a prospective, nationwide, multicenter, non-interventional, observational cohort study designed to describe acotinib real-world treatment patterns, dosing, safety, and effectiveness in Chinese patients with CLL/SLL and MCL treated according to the local prescribing label. Approximately 30 study sites are anticipated. The target sample size is approximately 160 patients (\~901L CLL/SLL, \~30 R/R CLL/SLL, \~40 R/R MCL); enrollment will terminate at the earlier of \~160 patients enrolled or 46 months of enrollment. The exploratory endpoint of MRD negativity rate was newly added in protocol v2.0; MRD assessment (sample type, sampling method, detection method, and threshold per routine practice) will be captured at baseline and follow-up.
783 studies on the registry are indexed under Lymphoma, Mantle-Cell; 146 are open to participants now.
This study's planned enrollment of 160 is above the median of 120 across 49 observational studies indexed under Lymphoma, Mantle-Cell.
Browse Lymphoma, Mantle-Cell studies →Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.
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Chinese patients with MCL (with ≥1 prior therapy) or CLL/SLL (treatment-naïve or with ≥1 prior therapy), treated with acotinib according to the local prescribing label, in routine clinical practice
Exclusion Criteria:
Chinese patients with MCL treated with acalabrutinib
Chinese patients with CLL/SLL treated with acalabrutinib
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.
Time frame: Oct 2029
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.
Time frame: Oct 2029
posology
Posology of acalabrutinib in Chinese CLL/SLL and MCL patients who received acalabrutinib according to Chinese label
Time frame: Oct 2029
rwOS - Real-world overall survival
Time from first dose of acotinib to death from any cause. Survival rates will be estimated using the Kaplan-Meier method, with 95% CIs as appropriate.
Time frame: Oct 2029
rwPFS - Real-world progression-free survival
Time from first dose of acotinib to documented disease progression or death from any cause, whichever occurs first, per investigator assessment per the local prescribing label.
Time frame: Oct 2029
rwRR - Real-world response rate
The proportion of patients achieving complete response (CR) or partial response (PR) per investigator assessment per the local prescribing label. The Clopper-Pearson 95% confidence intervals (CIs) will also be presented.
Time frame: Oct 2029
MRD negativity rate
The proportion of Chinese patients with CLL/SLL or MCL achieving undetectable measurable residual disease (MRD) at any post-baseline assessment following treatment with acotinib per the local prescribing label; sample type (peripheral blood and/or bone marrow), sampling method, detection method, and threshold for negativity will be captured per the investigator's routine practice. The Clopper-Pearson 95% confidence intervals (CIs) will be reported.
Time frame: Oct 2029
Plan to share: Undecided
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