Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06504199
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Obinutuzumab Zanubrutinib and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Open-Label Single-Arm Study of Obinutuzumab Zanubrutinib and Lenalidomide Followed Short-Cycle Cytarabine in First-Line Treatment of Mantle Cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZGR
Brief Summary:
This study aims to preliminarily explore the efficacy and safety of the combination of Obinutuzumab and Zanubrutinib plus Lenalidomide ZGR followed by a short cycle of cytarabine and Obinutuzumab in the induction treatment of newly diagnosed mantle cell lymphoma MCL The investigators propose ZGR followed by a short cycle of Obinutuzumab and cytarabine could be an effective first-line treatment for MCL
Detailed Description:
Based on the clinical need for first-line treatment of MCL this study proposed to enroll 39 patients with MCL who have not previously received any systemic therapy for MCL All patients were treated with ZGR regimen for 6 cycles after enrollment followed by 3 cycles of Obinutuzumab cytarabine in 28-day cycles For non-high-risk patients lenalidomide and Zanubrutinib were used for maintenance high-risk patients continued Lenalidomide and Zanubrutinib for maintenance following CAR-T cell therapy for 1 year for Lenalidomide and 2 years for Zanubrutinib The primary endpoint of CRR and secondary endpoints including ORR PFS DoR and OS were followed and recorded to explore the efficacy and safety of ZGR followed by a short cycle of Obinutuzumab and cytarabine induction therapy in treatment-naive MCL
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None