Ignite Creation Date:
2024-10-25 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588205
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-02
Brief Title:
Exploring the Clinical Impact of MYC Aberrations and Their Relationship with Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade C Cell Lymphoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multicenter Observational Retrospective-prospective Study Exploring the Clinical Impact of MYC Aberrations and Their Relationship with Microenvironment in Diffuse Large B Cell Lymphoma and High-Grade B Cell Lymphoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
FIL_MIMYC
Brief Summary:
This is a observational retrospective and prospective study designed to assess the potential correlations between MYC alterations lymphoma mutational landscape and functional immune contextures in Diffuse Large B-cell Lymphoma or High-Grade B-cell Lymphoma
Detailed Description:
Diffuse large B-cell lymphomas DLBCL and high-grade B-cell lymphomas HGBCL are a group of heterogeneous diseases representing more than a third of lymphomas in adults 5-years overall survival of patients affected by DLBCL and HGBCL is around 70-60 and efficient prognostic markers are warranted to improve patients survival by better tailored therapeutical approaches
Genetic rearrangements of the MYC gene occur in 5-10 of DLBCL at diagnosis and the presence of double translocations involving both MYC and BCL2 double-hit DH associated or not with BCL6 triple-hit TH translocation is associated with unfavorable prognostic impact
Intensification of treatment compared to standard chemotherapy R-CHOP appears to reduce the risk of recurrence in patients with DH or TH lymphomas but a survival advantage has not been demonstrated
Numerical changes in MYC gain of copy number GCN may also affect the outcome of patients with DLBCL but their prognostic relevance and the benefit of treatment intensification is still controversial
Additionally novel scientific evidence indicates a contribution of lymphoma micro-environment LME in disease genomic subtype and patient prognosis
We aimed this study at investigating potential biological links between MYC aberrations lymphoma mutational landscape and functional immune contextures in DLBCL and HGBCL
Genetic rearrangements of the MYC gene occur in 5-10 of DLBCL at diagnosis and the presence of double translocations involving both MYC and BCL2 double-hit DH associated or not with BCL6 triple-hit TH translocation is associated with unfavorable prognostic impact
Intensification of treatment compared to standard chemotherapy R-CHOP appears to reduce the risk of recurrence in patients with DH or TH lymphomas but a survival advantage has not been demonstrated
Numerical changes in MYC gain of copy number GCN may also affect the outcome of patients with DLBCL but their prognostic relevance and the benefit of treatment intensification is still controversial
Additionally novel scientific evidence indicates a contribution of lymphoma micro-environment LME in disease genomic subtype and patient prognosis
We aimed this study at investigating potential biological links between MYC aberrations lymphoma mutational landscape and functional immune contextures in DLBCL and HGBCL
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