Health TrialsbyHealthPanel

Zanubrutinib Combined With G-CVP in Previously Untreated FL

ConditionFollicular Lymphoma ( FL)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Pregnant or breastfeeding women;

Abnormal liver or kidney function, defined as: serum direct/indirect bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), or serum creatinine > 2 × upper limit of normal (ULN); creatinine clearance < 60 mL/min (unless due to lymphoma involvement);

History of deep vein thrombosis (DVT) or pulmonary embolism (PE) within the past 12 months;

Absolute neutrophil count (ANC) < 1.5 × 10⁹/L, platelets < 75 × 10⁹/L, or hemoglobin < 70 g/L (unless due to bone marrow involvement by lymphoma);

Trial design

Design model

Single group

Treatments tested in this trial

  • zanubrutinib, obinutuzumab,combined with CVP

    Drug

    Zanubrutinib (160 mg, twice daily \[bid\]), obinutuzumab (1000 mg on cycle 1 \[C1\], days 1, 8, and 15; on cycle 2 - 6 \[C 2-6\], day 1), cyclophosphamide (750 mg/㎡ on day 1), vincristine (1.4 mg/㎡, maximum dose 2 mg on day 1), and prednisone tablets (40 mg/㎡ once daily \[qd\] orally on days 1-5) were used every 21 days as a treatment cycle. Six cycles of treatment were completed, and the efficacy was reviewed every two cycles. Patients with PD were excluded from the group. MRD was detected after six cycles. If MRD was negative, routine maintenance therapy was performed (obinutuzumab 1000 mg once every 8 weeks, a total of 12 times). If MRD was positive, Zanubrutinib (160 mg, continuous bid) was added to the conventional maintenance therapy for 12 months.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: ZG- CVPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

CRR

CRR (%) is defined as the number of patients achieving a complete response as a proportion of total patients evaluable for response.

Time frame
From date of enrollment until the date of first documented CR assessed up to 2.5 years.

Secondary outcomes

1

ORR

ORR (%) is defined as the number of patients achieving a complete response or partial response as a proportion of total patients evaluable for response.

Time frame
From date of enrollment until the date of first documented response assessed up to 2.5 years.
2

PFS

PFS is defined as the time interval from the time of enrollment on this study to the date of PD or death, whichever came first.

Time frame
From date of enrollment until the date of first documented progression assessed up to 5 years.
3

OS

OS is defined as the time interval from the time of enrollment in this study to the date of death from any cause. If the subject is alive or the vital status is unknown, OS will be censored at the date that the subject is last known to be alive, or their last contact date.

Time frame
From date of enrollment until the date of first documented death assessed up to 5 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Lead sponsor

Source ClinicalTrials.gov
Apply now