Zanubrutinib and G-CHOP in Untreated Intermediate-high Risk Follicular Lymphoma

Phase 2

Not yet recruiting

• Conditions: FL
• Interventions: Drug: Zanubrutinib; Drug: Obinutuzumab; Drug: Prednisone; Drug: Cyclophosphamide; Drug: Vincristine; Drug: Doxorubicin

• Registration Number: NCT06474481
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

:This is a an open-label, single-arm study to evaluate the efficacy and safety of zanubrutinib and G-CHOP in untreated Intermediate-high risk Follicular Lymphoma patients.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-19
• Last Update Submitted: 2024-06-19
• Study First Posted: 2024-06-25
• Last Update Posted: 2024-06-25
• Study Start: 2024-07
• Primary Completion: 2027-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Prednisone	Induction: Zanubrutinib and G-CHOP 4-6cycles Maintenance: Zanubrutinib and Obinutuzumab 1 year
Treatment arm	Obinutuzumab	Induction: Zanubrutinib and G-CHOP 4-6cycles Maintenance: Zanubrutinib and Obinutuzumab 1 year
Treatment arm	Zanubrutinib	Induction: Zanubrutinib and G-CHOP 4-6cycles Maintenance: Zanubrutinib and Obinutuzumab 1 year
Treatment arm	Cyclophosphamide	Induction: Zanubrutinib and G-CHOP 4-6cycles Maintenance: Zanubrutinib and Obinutuzumab 1 year
Treatment arm	Vincristine	Induction: Zanubrutinib and G-CHOP 4-6cycles Maintenance: Zanubrutinib and Obinutuzumab 1 year
Treatment arm	Doxorubicin	Induction: Zanubrutinib and G-CHOP 4-6cycles Maintenance: Zanubrutinib and Obinutuzumab 1 year

Primary Outcome Measures

Name	Time	Method
CR (complete response) rate after induction (4 or 6 Cycles) by investigator (INV)	From enrollment to the end of treatment at cycle 4 or 6 (each cycle is 28 days)	Percentage of participants with complete response was determined on the basis of investigator assessments according to 2014 Lugano criteria

Secondary Outcome Measures

Name	Time	Method
Objective Response rate after induction by investigator (INV)	From enrollment to the end of end of treatment at cycle 4 or 6 (each cycle is 28 days)	ORR is defined as the proportion of patients achieving complete response (CR) or partial response (PR), as determined by INV according to 2014 Lugano criteria
Progression free survival (PFS)	From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years	-PFS defined as time from the date of enrollment to the date of first confirmed disease progression or death due to any cause, whichever occurs first, as determined by INV
Overall survival (OS)	From the date of cycle 1, day 1 to the date of death regardless of cause, assessed up to 3 years	Overall survival (OS) is defined as the duration from the date of initiation of the first cycle of treatment to the date of death because of any cause