A Multicenter, Prospective, Phase II Study of Zanubrutinib for Maintenance in Patients With Mantle Cell Lymphoma

Sponsor
Fudan University
Study ID
NCT06341556
Phase
PHASE2
Status
Recruiting
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Conditions

  • Maintenance Therapy
  • Mantle Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Zanubrutinib — DRUG
    Patients diagnosed with mantle cell lymphoma who have achieved remission (CR or PR) by first-line immunochemotherapy, will be treated with Zanubrutinib monotherapy for 2 years (or until PD, intolerable toxicity, death, withdrawal, or study termination).

Study Details

This study aims to evaluate whether maintenance therapy with Zanubrutinib monotherapy could improve the 2-year progression free survival (PFS) of patients with mantle cell lymphoma who had remission after first-line immunochemotherapy

Key Dates

First listed
Apr 2, 2024
Start date
May 24, 2024
Status verified
Aug 2024
Primary completion
Mar 31, 2026
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: Experimental group
    maintenance of zanubrutinib monotherapy

Primary Outcome Measure

2-year progression-free survival (PFS) [ Time Frame: From date of patients sign informed consent until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years ]

Central Contacts

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