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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Sun yat-sen university cancer center, Sun yat-sen university
RECRUITING
Guangzhou
Contact Information
Primary
Qingqing Cai
caiqq@sysucc.org.cn
02087342823
Time Frame
Start Date: 2025-04-14
Estimated Completion Date: 2033-02-20
Participants
Target number of participants: 50
Treatments
Experimental: Acalabrutinib in combination with Rituximab
Eligible patients will receive:~Acalbrutinib : 100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment.~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.
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov