Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-05 @ 6:11 PM
Study NCT ID:
NCT05922904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-10
First Post:
2023-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET Adapted Brentuximab Vedotin and Pembrolizumab in Combination With Doxorubicin and Dacarbazine in Classic Hodgkin Lymphoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
PET Adapted Brentuximab Vedotin and Pembrolizumab in Combination With Doxorubicin and Dacarbazine in Classic Hodgkin Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-10
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 learn about the effects of brentuximab vedotin and pembrolizumab in combination with doxorubicin and dacarbazine when given to patients who have Stage II cHL with bulky mediastinal disease or advanced cHL (Stage III or IV) and who have not received treatment for the disease.
Detailed Description:
Primary Objectives:
● To assess the complete response (CR) rate at the end of therapy (EOT) with Brentuximab vedotin and pembrolizumab, doxorubicin and dacarbazine in subject with previously untreated stage II bulky mediastinal disease or advanced stage cHL.
Secondary Objectives:
* To assess the safety of BvP+AD
* To assess the complete remission rate at interim PET (CR iPET)
* To assess the overall response rate (ORR)
* To assess the duration of response (DOR)
* To assess the duration of complete response (DOCR)
* To assess event-free survival (EFS)
* To assess progression free survival (PFS)
* To assess overall survival (OS)
● To assess the complete response (CR) rate at the end of therapy (EOT) with Brentuximab vedotin and pembrolizumab, doxorubicin and dacarbazine in subject with previously untreated stage II bulky mediastinal disease or advanced stage cHL.
Secondary Objectives:
* To assess the safety of BvP+AD
* To assess the complete remission rate at interim PET (CR iPET)
* To assess the overall response rate (ORR)
* To assess the duration of response (DOR)
* To assess the duration of complete response (DOCR)
* To assess event-free survival (EFS)
* To assess progression free survival (PFS)
* To assess overall survival (OS)
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-05028 | OTHER | NCI-CTRP Clinical Trials Registry | View |