Ignite Creation Date:
2024-07-17 @ 10:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471738
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-18
Brief Title:
Combination of Zanubrutinib Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma
Sponsor:
Chinese PLA General Hospital
Organization:
Chinese PLA General Hospital
Study Overview
Official Title:
Safety and Efficacy of Zanubrutinib in Combination With Rituximab and Venetoclax in Previously Untreated Follicular Lymphoma An Open Label Phase 2 Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZARAV
Brief 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 FLis the most common inert non Hodgkins 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None