Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652139
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Selinexor Combined With BEAM for ASCT in RR DLBCL With MYC Positive
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-center Randomized Controlled Clinical Study of Selinexor Combined With BEAM as a Preconditioning Regimen for ASCT in Relapsed and Refractory Diffuse Large B-cell Lymphoma With MYC Positive
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
To evaluate the efficacy and safety of selinexor combined with BEAM pretreatment regimen in ASCT of recurrent and refractory DLBCL patients with immunohistochemical positive for MYC
Detailed Description:
This trial included 82 patients who were randomly divided into pre-treatment with selinexor combined with BEAM regimen experimental group or BEAM regimen control group according to 11 and then underwent ASCT therapy The trial included a screening period a treatment period 2 weeks before and after transplantation and a follow-up period 2 years after autologous transplantation At 3 6 9 and 18 months after ASCT blood routine blood biochemistry B-ultrasound of liver bile pancreas spleen and lymph node and whole body enhanced CT were performed At 1 and 2 years after ASCT blood routine blood biochemistry and whole body PET-CT evaluation were performed until the end of the study
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