Mantle Cell Lymphoma (MCL)RESANCT06767891
Real-world Study of Acalabrutinib
An observational study of Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 2 Jul 2024to Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: A Prospective, National, Multicenter, Observational Real-World Study of Acalabrutinib in Chinese Patients With MCL/CLL/SLL(RESA)
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.
Read the 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.
- Conditions
- Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- Keywords
- Acalabrutinib, Acotinib, MCL, CLL/SLL
- Medical subject headings
- Lymphoma, Mantle-Cell, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| MCL | Chinese patients with MCL treated with acalabrutinib | |
| CLL/SLL | Chinese patients with CLL/SLL treated with acalabrutinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Oct 2029
Secondary outcomes (2)
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.
Measured: Oct 2029
posology
Posology of acalabrutinib in Chinese CLL/SLL and MCL patients who received acalabrutinib according to Chinese label
Measured: Oct 2029
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start2 Jul 2024
- Primary completionOct 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell Lymphoma (MCL)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06767891
- Sponsor's protocol ID
- ESR-22-21992
- Acronym
- RESA
- Status last verified
- Aug 2026
- First submitted
- 30 Oct 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, National, Multicenter, Observational Real-World Study of Acalabrutinib in Chinese Patients With MCL/CLL/SLL(RESA)
- ClinicalTrials.gov ID
- NCT06767891
- Acronym / sponsor ID
- RESA / ESR-22-21992
- Conditions
- Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)
- Keywords
- Acalabrutinib, Acotinib, MCL, CLL/SLL
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 2 Jul 2024 (actual)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 10 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCL | – | –Chinese patients with MCL treated with acalabrutinib |
| CLL/SLL | – | –Chinese patients with CLL/SLL treated with acalabrutinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
treatment patterns
Time frame: 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.
2 secondary outcomes
The percentage of patients with AEs, SAEs (safety)
Time frame: Oct 2029
posology
Time frame: Oct 2029
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mantle Cell Lymphoma (MCL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment patterns (time frame: Oct 2029). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.