Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06355401
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-04-04
Brief Title:
Maintenance Hormonal Therapy and DLBCL
Sponsor:
Sohag University
Organization:
Sohag University
Study Overview
Official Title:
Effect of Maintenance Hormonal Therapy on the Outcome of Patients With DLBCL
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
None
Brief Summary:
the study aims to detect the benefit of maintenance tamoxifen after achieving CR with conventional immuno-chemotherapy andor radiotherapy in patients with DLDCL
Detailed Description:
Diffuse large B-cell lymphoma DLBCL is the most common form of aggressive non-Hodgkin lymphoma The standard immuno-chemotherapy R-CHOP markedly improves the prognosis of DLBCL but up to 40 of patients still experience relapse or incomplete remission So there is a need for new targeted therapy for such malignancy Recent studies identified a potential novel target in DLBCL the ESR2 gene which codes for the estrogen receptor beta ERβ protein a receptor that can be targeted with selective ER modulators SERMs such as tamoxifen Recent data shows that exposure of DLBCL cell lines to tamoxifen either alone or in combination with CHOP chemotherapy results in apoptosis and growth inhibition in vitro and in vivo these data suggest the potential importance of ERβ in the pathogenesis of DLBCL as well as a potential role for tamoxifen in the treatment of DLBCL50-100 patients with newly diagnosed DLBCL will be treated with standard immuno-chemotherapy according to disease stage with detection of ERB and ERA on the tissue samples using IHC After the end of chemotherapy treatment patients who achieve CR will be randomized to either receive tamoxifen maintenance 20 mg daily versus follow up to evaluate possible tamoxifen effect on disease recurrence DFS and OS
PT who achieve CR after 2nd line chemotherapy versus post BMT will also be recruited
PT who achieve CR after 2nd line chemotherapy versus post BMT will also be recruited
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