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Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT06846489•Sun Yat-sen University

View on ClinicalTrials.gov

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

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: 1. Acalabrutinib: 100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment 2. 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age ≥18 years.
•2. Histologically confirmed CD20+ mantle cell lymphoma.
•3. No prior anti-lymphoma treatment.
•4. Ann Arbor stage II-IV.
•5. ECOG performance status 0-2, no deterioration \>2 weeks before baseline or first dose.
•6. Younger subjects (\<65) must meet:
•1. Low to intermediate risk sMIPI (0-5)
•2. Ki67 \< 50%
•3. No TP53 mutation (NGS)
•4. Lesion diameter ≤5 cm
+7 more criteria

Exclusion Criteria

•1. Participants with tumor burden reduction prior to stem cell transplantation.
•2. History of active lymphoma central nervous system (CNS) involvement, leptomeningeal disease, or spinal cord compression.
•3. 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).
•4. History of progressive multifocal leukoencephalopathy (PML) or current diagnosis of PML.
•5. Received any investigational drug within 30 days (or 5 half-lives, whichever is shorter) prior to the first dose of the investigational drug.
•6. 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.
•7. 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.
•8. 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.
•9. 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.
•10. Received a live-virus vaccine within 28 days prior to the first dose of the investigational drug.
+11 more criteria

Locations (1)

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

Guangzhou, Guangdong, China

Key Dates

Start Date

April 14, 2025

Primary Completion Date

February 10, 2033

Completion Date

February 20, 2033

Last Updated

June 3, 2025

Enrollment

ESTIMATED participants

Conditions

Mantle Cell Lymphoma (MCL)

Interventions

Acalabrutinib

DRUG

Rituximab

DRUG

Contacts

Qingqing Cai

CONTACT

02087342823 caiqq@sysucc.org.cn

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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