Trials / Recruiting
RecruitingNCT06471738
Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma
Safety and Efficacy of Zanubrutinib in Combination With Rituximab and Venetoclax in Previously Untreated Follicular Lymphoma: An Open Label, Phase 2 Study
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Chinese PLA General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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) .
Detailed description
Follicular lymphoma (FL)is the most common inert non Hodgkin's lymphoma (iNHL). Their natural courses are slow but highly variable. The standard first-line treatment of advanced FL is based on rituximab. Whether combined with chemotherapy or not, it can induce lasting remission, but it is usually incurable. Although the first-line immunochemotherapy regimen has high efficacy, it also has high toxicity. Cytotoxic chemotherapy is related to many side effects, including bone marrow suppression and immunosuppression, gastrointestinal and cardiac toxicity, neurotoxicity and the occurrence of secondary tumors. About 20% of FL patients relapse within 2 years after first-line chemotherapy. The overall prognosis of these patients is poor. This clinical trial aims to evaluate the feasibility and efficacy of free-chemotherapy regimen (zanubrutinib combined with venetoclax and Rituximab) in patients with previously untreated follicular lymphoma.
Conditions
- Ann Arbor Stage II Follicular Lymphoma
- Grade 1 Follicular Lymphoma
- Ann Arbor Stage III Follicular Lymphoma
- Ann Arbor Stage IV Follicular Lymphoma
- Grade 2 Follicular Lymphoma
- Grade 3a Follicular Lymphoma
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Zanubrutinib | BTK inhibitor |
| BIOLOGICAL | Rituximab | Monoclonal antibody to CD20 |
| DRUG | Venetoclax | BCL-2 inhibitor |
Timeline
- Start date
- 2024-07-10
- Primary completion
- 2026-12-30
- Completion
- 2027-06-01
- First posted
- 2024-06-24
- Last updated
- 2024-07-18
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06471738. Inclusion in this directory is not an endorsement.