Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652165
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Zanubrutinib Combined With BEAM for ASCT in Relapsed and Refractory DLBCL
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-center Randomized Controlled Clinical Study of Zanubrutinib Combined With Carmustine Etoposide Cytarabine and Melphalan BEAM as a Preconditioning Regimen for ASCT in Relapsed and Refractory DLBCL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This trial is a prospective single-center randomized controlled clinical research The intention is to evaluate the efficacy and safety of zanubrutinib combined with BEAM as a pretreatment regimen for ASCT in relapsed and refractory DLBCL patients through prospective clinical studies
Detailed Description:
This trial includes 66 patients with recurrent or refractory DLBCL who will be randomly divided into a 11 combination of zanubrutinib and BEAM regimen pretreatment experimental group or a standard BEAM regimen pretreatment control group and then undergo ASCT treatment The entire trial includes a screening period before the start of autologous stem cell transplantation pretreatment a treatment period -8 days to -2 days a total of 7 days and a follow-up period 2 years after autologous stem cell transplantation
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