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

Phase 2

Not yet recruiting

• Conditions: Mantle Cell Lymphoma (MCL)
• Interventions: Drug: Acalabrutinib; Drug: Rituximab

• Registration Number: NCT06846489
• Lead Sponsor: Sun Yat-sen University

Brief 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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-16
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-25
• Study First Posted: 2025-02-26
• Last Update Posted: 2025-02-27
• Study Start: 2025-03-01
• Primary Completion: 2033-02-10
• Study Completion: 2033-02-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acalabrutinib in combination with Rituximab	Acalabrutinib	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.
Acalabrutinib in combination with Rituximab	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.

Primary Outcome Measures

Name	Time	Method
Complete Response(CR)	From the start of treatment with the investigational drug until 12 months	Defined as the proportion of patients who achieve complete remission

Secondary Outcome Measures

Name	Time	Method
Objective response rate(ORR)	From the start of treatment with the investigational drug until 12 months	The proportion of patients who achieve complete remission (CR) or partial remission (PR) .
Duration of Response(DOR)	The time from the patient's first efficacy assessment achieving CR or PR until disease progression, up to 5 years	To investigate the preliminary anti-tumor efficacy
Progression-free survival(PFS)	From the date of enrollment until the date of the first documented progression or date of death from any cause, whichever came first, up to 5 years	To investigate the preliminary anti-tumor efficacy
Overall survival(OS)	From the date of enrollment until the date of death from ant cause, up to 5 years	To investigate the preliminary anti-tumor efficacy

Trial Locations

Locations (1)

Sun yat-sen university cancer center, Sun yat-sen university; 🇨🇳 Guangzhou, Guangdong, China