Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma

Sponsor
Chinese PLA General Hospital
Study ID
NCT06471738
Phase
PHASE2
Status
Recruiting
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Conditions

  • Ann Arbor Stage II Follicular Lymphoma
  • Ann Arbor Stage III Follicular Lymphoma
  • Ann Arbor Stage IV Follicular Lymphoma
  • Grade 1 Follicular Lymphoma
  • Grade 2 Follicular Lymphoma
  • Grade 3a Follicular Lymphoma

Eligibility Criteria

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

Interventions

  • Zanubrutinib — DRUG
    BTK inhibitor
  • Rituximab — BIOLOGICAL
    Monoclonal antibody to CD20
  • Venetoclax — DRUG
    BCL-2 inhibitor

Study Details

This is a single center, open label, single arm phase II clinical trial. The objective of this study is to assess the feasibility and efficacy of zanubrutinib combined with venetoclax and Rituximab in patients with previously untreated follicular lymphoma (FL) .

Key Dates

Start date
Jul 10, 2024
Status verified
Jul 2024
Primary completion
Dec 30, 2026
Completion
Jun 1, 2027

Study Design

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

Arms

  • Experimental: Treatment (zanubrutinib, venetoclax, rituximab)
    stage I (cycles 1-3, every 4 weeks): zanubrutinib PO 160mg, BID; rituximab IV on day 1. stage II (cycles 4-9, every 4 weeks): if complete response : zanubrutinib PO 160mg, BID; rituximab IV on day 1. if no complete response : zanubrutinib PO160mg, BID; rituximab IV on day 1 and Venetoclax PO (100mg D1, 200mg D2, and 400mg D3 of cycle 4; 400mg QD).

Primary Outcome Measure

CR rate [ Time Frame: Within 6 months of therapy completion ]

Central Contacts

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