Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06563245
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-18
Brief Title:
Brentuximab Vedotin for Newly Diagnosed cHL in Chinese CAYA Based on PETCT Assessment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase IIIII Study of Brentuximab Vedotin for Newly Diagnosed Classical Hodgkin Lymphoma in Chinese CAYA Based on PETCT Assessment
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:
Generally pediatric patients tolerate acute toxicities but are vulnerable to late effects Thus increasing chemotherapy intensity to achieve more rapid complete early response to limit radiation therapy is worth testing In this CCCG-HL-2024 study Brentuximab vedotin Bv was used to replace VCR and bleomycin in the ABVE-PC regimen in the previous CCCG-HD-2018 study respectively to form a Bv-AEPC regimen for the treatment of newly diagnosed classic Hodgkin lymphoma cHL in children adolescents and young adults On the premise of maintaining a 4-year event free survival EFS90 in the low- intermediate-and high-risk groups increase the early assessment complete response rate the overall early complete response rate increased by 20 that is from 540 to 740 to further reduce the proportion of children receiving radiotherapy to benefit them
Detailed Description:
In this CCCG-HL-2024 study Brentuximab vedotin Bv was used to replace VCR and bleomycin in the ABVE-PC regimen in the previous CCCG-HD-2018 study respectively to form a Bv-AEPC regimen for the treatment of newly diagnosed classic Hodgkin lymphoma cHL in children adolescents and young adults Bv is currently the most widely used new drug in childhood cHL
For patients in the intermediatehigh-risk group who did not achieve metabolic complete remission rate CMR at the early assessment based on PETCT results an intensive regimen of Bv-Dac-APC Bv-APC plus dacarbazine was applied for 2 or 3 courses to further improve event-free survival without increasing long-term reproductive toxicity
For patients in the intermediatehigh-risk group who did not achieve CMR after the Bv-Dac-AEPC regimen a modified Check Mate 744 regimen PD-1 monoclonal antibody Bv-bedamostine autologous stem cell transplantationradiotherapy was applied to improve the CMR of patients before irradiation hoping to reduce the primary treatment failure rate to almost zero
For patients in the intermediatehigh-risk group who did not achieve metabolic complete remission rate CMR at the early assessment based on PETCT results an intensive regimen of Bv-Dac-APC Bv-APC plus dacarbazine was applied for 2 or 3 courses to further improve event-free survival without increasing long-term reproductive toxicity
For patients in the intermediatehigh-risk group who did not achieve CMR after the Bv-Dac-AEPC regimen a modified Check Mate 744 regimen PD-1 monoclonal antibody Bv-bedamostine autologous stem cell transplantationradiotherapy was applied to improve the CMR of patients before irradiation hoping to reduce the primary treatment failure rate to almost zero
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