NCT06767891Enrolling by invitation
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 · Last updated 8 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 160 (estimated)
- First submitted
- 30 Oct 2024
- Start date
- 2 Jul 2024
- Primary completion date
- Oct 2029
- Lead sponsor
- Ruijin Hospital
- NCT number
- NCT06767891
What you commit to
- Study type: Observational
- Planned participants: 160
- From 2 Jul 2024 to the primary completion date, Oct 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 3: Concurrent participation in another interventional clinical study
Lab values
- 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.
Other
- 1: Ineligible for acalabrutinib treatment assessed by investigators (physician's evaluation)
- 2: Progression after accepting other BTKi treatment before use of acalabrutinib
Who the study is looking for
- 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)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.