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

Sponsor
Sun Yat-sen University
Study ID
NCT06846489
Phase
PHASE2
Status
Recruiting
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Conditions

  • Mantle Cell Lymphoma (MCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Acalabrutinib — DRUG
    100 mg bid po, continue treatment until disease progression, intolerable toxicity, or completion of 24 months of treatment.
  • Rituximab — DRUG
    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

Study Details

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

Key Dates

Start date
Apr 14, 2025
Status verified
Feb 2025
Primary completion
Feb 10, 2033
Completion
Feb 20, 2033

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Complete Response(CR) [ Time Frame: From the start of treatment with the investigational drug until 12 months ]

Central Contacts

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