Actively Recruiting
Zanubrutinib Combined With G-CVP in Previously Untreated FL
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-05-07
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to learn the efficacy and safety of zanubrutinib in combination with G-CVP in previously untreated follicular lymphoma patients The main questions it aims to answer are: (1) Efficacy and safety of patients receiving zanubrutinib, obinutuzumab combined with cyclophosphamide, vincristine, and prednisone (CVP) regimen. (2) The difference in efficacy of patients with different minimal residual disease (MRD) status after treatment. Participants will receive zanubrutinib combined with G-CVP, maintenance therapy will be determined by the MRD status after treatment.
CONDITIONS
Official Title
Zanubrutinib Combined With G-CVP in Previously Untreated FL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed CD20-positive follicular lymphoma (grades 1, 2, or 3a) diagnosed by WHO 2022 criteria
- Clear need for treatment due to symptoms, organ problems, cytopenia from bone marrow lymphoma, bulky disease, or progressive disease
- No prior systemic therapy for lymphoma
- Age between 18 and 80 years
- Eastern Cooperative Oncology Group (ECOG) performance status under 2
- Expected survival greater than 2 years
- At least one measurable lesion 1.5 cm or larger, or extranodal lesion 1 cm or larger
- Willingness to participate and comply with treatment and follow-up
You will not qualify if you...
- Pregnant or breastfeeding women
- Abnormal liver or kidney function with values over twice the upper limit of normal or creatinine clearance below 60 mL/min unless due to lymphoma
- History of deep vein thrombosis or pulmonary embolism within the past 12 months
- Low blood counts: neutrophils under 1.5 x 10^9/L, platelets under 75 x 10^9/L, or hemoglobin under 70 g/L unless caused by lymphoma
- Long-term use of strong or moderate CYP3A inducers
- Known allergy to any study drug components
- Active other cancers except certain cured or localized types with over 5 years disease-free
- Severe ongoing infections
- Drug abuse or medical, psychological, or social conditions interfering with participation
- Any other condition the investigator considers makes the patient ineligible
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
Z
Zhitao Ying
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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