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
• 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:
∙ 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.