Clinical trial · Observational
Real-world Study of Acalabrutinib
A Prospective, National, Multicenter, Observational Real-World Study of Acalabrutinib in Chinese Patients With MCL/CLL/SLL(RESA)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 9, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260909-000002
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) | Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Mantle Cell Lymphoma (MCL) | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- MCL
- description
- Chinese patients with MCL treated with acalabrutinib
- label
- CLL/SLL
- description
- Chinese patients with CLL/SLL treated with acalabrutinib
Primary outcomes (1)
- measure
- treatment patterns
- timeFrame
- Oct 2029
- description
- 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 outcomes (2)
- measure
- The percentage of patients with AEs, SAEs (safety)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available