Mantle Cell Lymphoma (MCL)Phase 2NCT06846489
Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma
A Phase 2 study testing Acalabrutinib and Rituximab in people with Mantle Cell Lymphoma (MCL), run by Sun Yat-sen University at 1 site in China.
Trial summary
This is a single- arm, open-label, multicenter, phase II study to evaluate Acalabrutinib plus Rituximab for the treatment of elderly or low- to intermediate-risk younger untreated mantle cell lymphoma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma (MCL)
- What is being tested?
- Acalabrutinib and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2025to 20 Feb 2033
- Phase
- Phase 2
- 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
Who may be able to join
- Age ≥18 years.
- Histologically confirmed CD20+ mantle cell lymphoma.
- No prior anti-lymphoma treatment.
- Ann Arbor stage II-IV.
- ECOG performance status 0-2, no deterioration >2 weeks before baseline or first dose.
- Younger subjects (<65) must meet:
Show all 17Show fewer
- Low to intermediate risk sMIPI (0-5)
- Ki67 < 50%
- No TP53 mutation (NGS)
- Lesion diameter ≤5 cm
- Non-blastoid, polymorphic disease
- At least one assessable lesion per Lugano 2014 criteria.
- Adequate organ and bone marrow function during screening.
- Female subjects must use contraception as per local regulations.
- Male subjects must agree to avoid sperm donation during the study and for 12 months post-rituximab.
- Willing to undergo all required assessments and procedures, including swallowing capsules/tablets.
- Able to understand the study's purpose and risks, and provide signed informed consent with authorization for the use of personal health information.
Who cannot join
- Participants with tumor burden reduction prior to stem cell transplantation.
- History of active lymphoma central nervous system (CNS) involvement, leptomeningeal disease, or spinal cord compression.
- Any disease evidence deemed by the investigator to be detrimental to the patient's participation or likely to affect protocol adherence (e.g., severe or uncontrolled systemic disease, including uncontrolled hypertension or kidney transplant).
- History of progressive multifocal leukoencephalopathy (PML) or current diagnosis of PML.
- Received any investigational drug within 30 days (or 5 half-lives, whichever is shorter) prior to the first dose of the investigational drug.
- Underwent major surgery within 30 days prior to the first dose of the investigational drug. Note: If the participant has undergone major surgery, they must be fully recovered from any toxicity and/or complications related to the surgery before the first dose.
Show all 21Show fewer
- A history of malignancy that could affect protocol adherence or interpretation of results, except for: a. Basal cell carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or prostate carcinoma in situ treated curatively at any time before the study. b. Other cancers that were treated surgically and/or with radiation, with no disease for ≥3 years without further treatment.
- Significant cardiovascular disease, such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months before screening, or any NYHA Class 3 or 4 heart disease during screening. Note:Participants with well-controlled, asymptomatic atrial fibrillation are allowed.
- Refractory nausea and vomiting, difficulty swallowing formulations, or malabsorption syndrome; chronic gastrointestinal disease, gastric bypass, or weight-loss surgery (e.g., Roux-en-Y); partial or complete bowel obstruction, or previous major intestinal surgery that may interfere with the absorption, distribution, metabolism, or elimination of the investigational drug.
- Received a live-virus vaccine within 28 days prior to the first dose of the investigational drug.
- Known HIV infection.
- Any active major infection (e.g., bacterial, viral, or fungal, including subjects with positive CMV DNA PCR).
- Serologic evidence of active hepatitis B or C infection.
- History of stroke or intracranial hemorrhage within 6 months prior to the first dose of the investigational drug.
- History of bleeding disorders (e.g., hemophilia, Von Willebrand disease).
- Requires or is receiving anticoagulation therapy with warfarin or equivalent vitamin K antagonists.
- Requires strong CYP3A inhibitors or inducers. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks before the first dose of the investigational drug is prohibited.
- Pregnancy or breastfeeding.
- Participation in another therapeutic clinical trial.
- Requires proton pump inhibitor therapy (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole).
- Currently has a life-threatening disease, medical condition, or organ system dysfunction that, in the investigator's judgment, may compromise the participant's safety or place the study at risk.
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, 1 recruiting
- Recruiting
Sun yat-sen university cancer center, Sun yat-sen university
Guangzhou, Guangdong, 51000
Qingqing Cai, 02087342823, caiqq@sysucc.org.cn
About this study
Official title: Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma: A Single-Arm, Open-Label, Multicenter, Phase II Study
This is a single- arm, open-label, multicenter, phase II study to evaluate Acalabrutinib plus Rituximab for the treatment of elderly or low- to intermediate-risk younger untreated mantle cell lymphoma
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of Acalabrutinib plus Rituximab for the treatment of elderly or low- to intermediate-risk younger untreated mantle cell lymphoma
Treatrment:
- Acalabrutinib: 100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment
- Rituximab: 375 mg/m2 IV, once weekly during the first cycle, then once monthly for 12 months, followed by once every 2 months, for a maximum of 24 months.
The primary study endpoint is the investigator-assessed complete response (CR) rate at 12 months.
- Conditions
- Mantle Cell Lymphoma (MCL)
- Being tested
- Acalabrutinib, Rituximab
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcalabrutinibDrug
100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment.
RituximabDrug
375 mg/m² IV, once weekly during the first cycle, then once monthly for 12 months, followed by once every 2 months, for a maximum of 24 months
| Study group | Role | What they receive |
|---|---|---|
| Acalabrutinib in combination with Rituximab | Experimental | Eligible patients will receive:
Acalbrutinib : 100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment.
Rituximab: 375 mg/m² IV, once weekly during the first cycle, then once monthly for 12 months, followed by once every 2 months, for a maximum of 24 months. Receives: Drug: Acalabrutinib; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Response(CR)
Defined as the proportion of patients who achieve complete remission
Measured: From the start of treatment with the investigational drug until 12 months
Secondary outcomes (4)
Objective response rate(ORR)
The proportion of patients who achieve complete remission (CR) or partial remission (PR) .
Measured: From the start of treatment with the investigational drug until 12 months
Duration of Response(DOR)
To investigate the preliminary anti-tumor efficacy
Measured: The time from the patient's first efficacy assessment achieving CR or PR until disease progression, up to 5 years
Progression-free survival(PFS)
To investigate the preliminary anti-tumor efficacy
Measured: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, up to 5 years
Overall survival(OS)
To investigate the preliminary anti-tumor efficacy
Measured: From the date of enrollment until the date of death from ant cause, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2025
- Study start14 Apr 2025
- Primary completion10 Feb 2033 (estimated)
- Study completion20 Feb 2033 (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 Sun Yat-sen UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qingqing Cai, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846489
- Sponsor's protocol ID
- B2024-843
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 3 Jun 2025
- Results posted
- 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma: A Single-Arm, Open-Label, Multicenter, Phase II Study
- ClinicalTrials.gov ID
- NCT06846489
- Acronym / sponsor ID
- B2024-843
- Conditions
- Mantle Cell Lymphoma (MCL)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 14 Apr 2025 (actual)
- Primary completion
- 10 Feb 2033 (estimated)
- Study completion
- 20 Feb 2033 (estimated)
- First posted
- 26 Feb 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.
This is a single- arm, open-label, multicenter, phase II study to evaluate Acalabrutinib plus Rituximab for the treatment of elderly or low- to intermediate-risk younger untreated mantle cell lymphoma
Detailed description
The purpose of this study is to evaluate the efficacy and safety of Acalabrutinib plus Rituximab for the treatment of elderly or low- to intermediate-risk younger untreated mantle cell lymphoma
Treatrment:
- Acalabrutinib: 100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment
- Rituximab: 375 mg/m2 IV, once weekly during the first cycle, then once monthly for 12 months, followed by once every 2 months, for a maximum of 24 months.
The primary study endpoint is the investigator-assessed complete response (CR) rate at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acalabrutinib in combination with Rituximab | Experimental | Drug: Acalabrutinib, Drug: RituximabEligible patients will receive: Acalbrutinib : 100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment. Rituximab: 375 mg/m² IV, once weekly during the first cycle, then once monthly for 12 months, followed by once every 2 months, for a maximum of 24 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥18 years.
- Histologically confirmed CD20+ mantle cell lymphoma.
- No prior anti-lymphoma treatment.
- Ann Arbor stage II-IV.
- ECOG performance status 0-2, no deterioration >2 weeks before baseline or first dose.
Key exclusion criteria (21 listed)
- Participants with tumor burden reduction prior to stem cell transplantation.
- History of active lymphoma central nervous system (CNS) involvement, leptomeningeal disease, or spinal cord compression.
- Any disease evidence deemed by the investigator to be detrimental to the patient's participation or likely to affect protocol adherence (e.g., severe or uncontrolled systemic disease, including uncontrolled hypertension or kidney transplant).
- History of progressive multifocal leukoencephalopathy (PML) or current diagnosis of PML.
- Received any investigational drug within 30 days (or 5 half-lives, whichever is shorter) prior to the first dose of the investigational drug.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acalabrutinib100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment. | Drug | Acalabrutinib in combination with Rituximab |
| Rituximab375 mg/m² IV, once weekly during the first cycle, then once monthly for 12 months, followed by once every 2 months, for a maximum of 24 months | Drug | Acalabrutinib in combination with Rituximab |
Primary outcome
Complete Response(CR)
Time frame: From the start of treatment with the investigational drug until 12 months
Defined as the proportion of patients who achieve complete remission
4 secondary outcomes
Objective response rate(ORR)
Time frame: From the start of treatment with the investigational drug until 12 months
Duration of Response(DOR)
Time frame: The time from the patient's first efficacy assessment achieving CR or PR until disease progression, up to 5 years
Progression-free survival(PFS)
Time frame: From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, up to 5 years
Overall survival(OS)
Time frame: From the date of enrollment until the date of death from ant cause, up to 5 years
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 3 Jun 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Mantle Cell Lymphoma (MCL)
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
RecruitingPhase 3
A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma
Lymphoma
RecruitingPhase 2
Auto Stem Cell Transplant for Lymphoma Patients
Non-Hodgkin Lymphoma, Hodgkin Lymphoma
Active, not recruitingPhase 1
Study to Evaluate Adverse Events, Change in Disease Activity, and How Oral ABBV-101 Moves Through the Body in Adult Participants With B-Cell Malignancies
Hematologic Cancer
Not yet recruitingPhase 2
A Study of Zanubrutinib, Obinutuzumab, and Sonrotoclax in People With Mantle Cell Lymphoma
Mantle Cell Lymphoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acalabrutinib and Rituximab in people with Mantle Cell Lymphoma (MCL), run by Sun Yat-sen University 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 17 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 3 Jun 2025. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Qingqing Cai (02087342823, caiqq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Response(CR) (time frame: From the start of treatment with the investigational drug until 12 months). 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 3 Jun 2025.