Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06846489

Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma

Led by Sun Yat-sen University · Updated on 2025-06-03

50

Participants Needed

1

Research Sites

409 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Histologically confirmed CD20 positive mantle cell lymphoma
  • No prior anti-lymphoma treatment
  • Ann Arbor stage II to IV
  • ECOG performance status 0 to 2 with no decline greater than 2 weeks before baseline or first dose
  • For younger subjects 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, non-blastoid polymorphic disease
  • At least one assessable lesion according to Lugano 2014 criteria
  • Adequate organ and bone marrow function at screening
  • Female participants must use contraception according to local regulations
  • Male participants must agree to avoid sperm donation during the study and for 12 months after rituximab
  • Willingness to undergo all required assessments and procedures including swallowing capsules or tablets
  • Ability to understand the study purpose and risks and provide signed informed consent including authorization for use of personal health information
Not Eligible

You will not qualify if you...

  • Tumor burden reduction prior to stem cell transplantation
  • History of active central nervous system lymphoma, leptomeningeal disease, or spinal cord compression
  • Any disease or condition judged by the investigator to interfere with participation or protocol adherence, including severe or uncontrolled systemic disease such as uncontrolled hypertension or kidney transplant
  • History or current diagnosis of progressive multifocal leukoencephalopathy (PML)
  • Use of investigational drugs within 30 days or 5 half-lives before first dose
  • Major surgery within 30 days before first dose unless fully recovered from surgery-related toxicity or complications
  • History of malignancy affecting protocol adherence, except certain skin or cervical carcinomas treated curatively at any time or cancers treated surgically or with radiation with no disease for 3 or more years
  • Significant cardiovascular disease including symptomatic arrhythmias, congestive heart failure, myocardial infarction within 6 months, or NYHA Class 3 or 4 heart disease
  • Refractory nausea, vomiting, swallowing difficulties, malabsorption syndrome, chronic gastrointestinal disease, gastric bypass or weight-loss surgery, bowel obstruction, or prior major intestinal surgery affecting drug absorption or metabolism
  • Receipt of live-virus vaccine within 28 days prior to first dose
  • Known HIV infection
  • Any active major infection including positive CMV DNA PCR
  • Serologic evidence of active hepatitis B or C infection
  • Stroke or intracranial hemorrhage within 6 months before first dose
  • History of bleeding disorders such as hemophilia or Von Willebrand disease
  • Requirement for anticoagulation therapy with warfarin or equivalent
  • Use of strong CYP3A inhibitors within 1 week or inducers within 3 weeks before first dose
  • Pregnancy or breastfeeding
  • Participation in another therapeutic clinical trial
  • Requirement for proton pump inhibitor therapy
  • Life-threatening disease or organ dysfunction compromising safety or study risk as judged by the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Sun yat-sen university cancer center, Sun yat-sen university

Guangzhou, Guangdong, China, 51000

Actively Recruiting

Loading map...

Research Team

Q

Qingqing Cai

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here