RecruitingPhase 2NCT06846489

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


Sponsor

Sun Yat-sen University

Enrollment

50 participants

Start Date

Apr 14, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of acalabrutinib (a targeted BTK inhibitor pill) and rituximab (an infused immunotherapy) can effectively treat mantle cell lymphoma (a type of blood cancer) without needing intensive chemotherapy, in elderly patients or in younger lower-risk patients. **You may be eligible if...** - You are 18 or older with confirmed mantle cell lymphoma (a specific type of B-cell lymphoma) - You have not previously received any treatment for lymphoma - Your cancer is Stage II–IV - If you are younger than 65, your cancer meets certain lower-risk criteria (specific genetic and tumor characteristics) **You may NOT be eligible if...** - You have received prior treatment for this lymphoma - Your cancer has transformed or has high-risk features (for younger patients) - You have significant organ problems or other blood cancers - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcalabrutinib

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

DRUGRituximab

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


Locations(1)

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

Guangzhou, Guangdong, China

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NCT06846489


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