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Enrolling by invitationNo phase

Observational Study of Acalabrutinib in Chinese Patients With Lymphoma or Leukemia

Observes how acalabrutinib is used in Chinese adults with mantle cell lymphoma or CLL/SLL.

Key facts

Who runs it
Ruijin Hospital
Where
Shanghai, ChinaSee the site
Trial code
Registry title
Real-world Study of Acalabrutinib
Status
Enrolling by invitation
People taking part
160 people, planned
Started
2 Jul 2024
Expected to end
Nov 2029
Type of study
Observational, 2 groups
Record updated
8 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with mantle cell lymphoma, chronic lymphocytic leukemia or small lymphocytic lymphoma who are treated with acalabrutinib in routine care in China.

Age
18 years or older at diagnosis
Sex
All sexes can join
Disease stage
Mantle cell lymphoma (MCL) after at least one earlier treatment, or CLL/SLL that is untreated or after at least one earlier treatment
Earlier treatment
MCL: at least one earlier treatment. CLL/SLL: no earlier treatment or at least one. No progression on another BTK inhibitor before acalabrutinib.

Main reasons for not taking part

  • The doctor judges the person ineligible for acalabrutinib treatment
  • Disease progressed on another BTK inhibitor before acalabrutinib
  • Taking part in another interventional clinical study at the same time
  • Cannot read, understand and sign the consent form

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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
  • 1: Ineligible for acalabrutinib treatment assessed by investigators (physician's evaluation)
  • 2: Progression after accepting other BTKi treatment before use of acalabrutinib

Where in China

  • Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaNo longer taking part

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • MCL

    Chinese patients with MCL treated with acalabrutinib

  • CLL/SLL

    Chinese patients with CLL/SLL treated with acalabrutinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective, National, Multicenter, Observational Real-World Study of Acalabrutinib in Chinese Patients With MCL/CLL/SLL(RESA)
Plain-language title
Observational Study of Acalabrutinib in Chinese Patients With Lymphoma or LeukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
8 September 2026