Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), Mantle Cell Lymphoma (MCL)
Conditions
Keywords
Acalabrutinib, Acotinib, MCL, CLL/SLL
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
Ruijin Hospital
AstraZeneca
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1: Patients should be ≥18 years old at diagnosis * 2: Diagnosed as MCL who have received at least one prior therapy, OR diagnosed as CLL/SLL who are treatment-naïve or have received at least one prior therapy (per the local prescribing label for acalabrutinib) * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| treatment patterns | Oct 2029 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The percentage of patients with AEs, SAEs (safety) | Oct 2029 | 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. |
| posology | Oct 2029 | Posology of acalabrutinib in Chinese CLL/SLL and MCL patients who received acalabrutinib according to Chinese label |
Countries
China
Outcome results
None listed