Actively Recruiting
Acalabrutinib Plus Rituximab for Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma: A Single-Arm, Open-Label, Multicenter Phase II Study
Led by Sun Yat-sen University · Updated on 2025-06-03
50
Participants Needed
1
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating Acalabrutinib combined with Rituximab for treating elderly patients or younger individuals with low- to intermediate-risk untreated mantle cell lymphoma. This phase II, single-arm, open-label, multicenter study aims to assess the effectiveness and safety of this treatment approach. The study focuses on patients with confirmed CD20+ mantle cell lymphoma who have not received prior anti-lymphoma therapy. Participants will receive Acalabrutinib orally at 100 mg twice daily and continue this treatment until disease progression, intolerable side effects, or completion of 24 months. Alongside, Rituximab is given intravenously at 375 mg/m2 once weekly during the first cycle, then once monthly for 12 months, followed by infusions every two months, for a maximum of 24 months. The treatment duration and dosing schedules are carefully structured to monitor response. During the study, participants will undergo regular assessments to evaluate their response to treatment, including measuring the complete response rate after 12 months. Additional outcome measures include objective response rate, duration of response, progression-free survival, and overall survival, with follow-up extending up to five years. Safety and organ function will be closely monitored, and participants must comply with all study procedures and provide informed consent. The study is sponsored by Sun Yat-sen University and started in April 2025, with completion anticipated by February 2033.
CONDITIONS
Brief Title
Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed CD20+ mantle cell lymphoma
- No prior anti-lymphoma treatment
- Ann Arbor stage II-IV
- ECOG performance status 0-2 with no deterioration in the 2 weeks before baseline or first dose
- For participants under 65 years: low to intermediate risk sMIPI (0-5), Ki67 less than 50%, no TP53 mutation by NGS, lesion diameter 5 cm or less, and non-blastoid, polymorphic disease
- At least one assessable lesion according to Lugano 2014 criteria
- Adequate organ and bone marrow function during screening
- Female participants must use contraception according to local regulations
- Male participants must avoid sperm donation during the study and for 12 months after Rituximab
- Willing to undergo all required assessments and procedures, including swallowing capsules or tablets
- Able to understand the study purpose and risks and provide signed informed consent with authorization for use of personal health information
You will not qualify if you...
- Tumor burden reduction prior to stem cell transplantation
- History of active lymphoma CNS involvement, leptomeningeal disease, or spinal cord compression
- Any disease or condition deemed by the investigator to affect participation or protocol adherence, including severe or uncontrolled systemic disease
- History or current diagnosis of progressive multifocal leukoencephalopathy (PML)
- Use of investigational drugs within 30 days prior to first dose
- Major surgery within 30 days prior to first dose without full recovery
- History of malignancy affecting study adherence or results, except certain treated skin or cervical cancers and other cancers in remission for 3 years or more
- Significant cardiovascular disease including symptomatic arrhythmias, recent myocardial infarction, or advanced heart failure
- Refractory nausea, vomiting, swallowing difficulties, malabsorption, gastrointestinal surgeries affecting drug absorption
- Live-virus vaccine within 28 days prior to first dose
- Known HIV infection
- Active major infection including positive CMV DNA PCR
- Active hepatitis B or C infection
- Stroke or intracranial hemorrhage within 6 months prior to first dose
- History of bleeding disorders
- Use of warfarin or equivalent anticoagulants
- Use of strong CYP3A inhibitors or inducers shortly before first dose
- Pregnancy or breastfeeding
- Participation in another therapeutic clinical trial
- Use of proton pump inhibitors
- Life-threatening disease or organ dysfunction that may compromise safety or study integrity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months or until disease progression or intolerable toxicity
Participants receive Acalabrutinib orally twice daily and Rituximab intravenously with a schedule starting weekly during the first cycle, then monthly for 12 months, followed by every 2 months, continuing up to 24 months or until disease progression or intolerable toxicity.
Weekly visits during the first cycle, then monthly visits for 12 months, followed by visits every 2 months up to 24 months
Trial Site Locations
Total: 1 location
1
Sun yat-sen university cancer center, Sun yat-sen university
Guangzhou, Guangdong, China, 51000
Actively Recruiting
Research Team
Q
Qingqing Cai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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