Ignite Creation Date:
2026-03-26 @ 3:21 PM
Ignite Modification Date:
2026-04-05 @ 3:02 PM
Study NCT ID:
NCT07171827
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2025-09-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti-CD30 (Brentuximab Vedotin) With AVD Versus ABVD Chemotherapy Protocol Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Sponsor:
Helwan University
Organization:
Study Overview
Official Title:
A Prospective Study Comparing Anti CD30 (Brentuximab Vedotin) With AVD Versus ABVD Chemotherapy Protocol Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Status:
COMPLETED
Status Verified Date:
2025-09
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:
This study will be held in the clinical oncology department, Helwan University, and Police Hospital, aiming to compare the efficacy and safety of anti-CD30 (BV) + Doxorubicin, Vinblastine, and Dacarbazine (AVD) versus the standard of care Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) as frontline therapy in patients with advanced classical Hodgkin lymphoma.
Detailed Description:
Hodgkin lymphoma (HL) is a malignancy that typically originates from germinal center B-lymphocytes. It is subdivided into classical type, which represents 95% of histopathology of HL cases (with four histological subtypes, namely, nodular sclerosis, mixed-cellularity, lymphocyte-rich, and lymphocyte-depleted), and nodular lymphocyte-predominant HL.
For patients with newly diagnosed Ann Arbor stage III/IV (advanced stage) HL, 70% are expected to be cured after treatment with Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD), which has been the preferred standard of care in the United States for many years.
The Risk-adapted therapy for advanced-stage Hodgkin lymphoma (RATHL) study assessed de-escalation to Doxorubicin, Vinblastine, and Dacarbazine (AVD) in patients with stage IIB, III, or IV HL (Deauville 1-3) and found that positron emission tomography (PET)-adapted de-escalation to AVD failed to demonstrate noninferiority compared with ABVD.
For patients with newly diagnosed Ann Arbor stage III/IV (advanced stage) HL, 70% are expected to be cured after treatment with Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD), which has been the preferred standard of care in the United States for many years.
The Risk-adapted therapy for advanced-stage Hodgkin lymphoma (RATHL) study assessed de-escalation to Doxorubicin, Vinblastine, and Dacarbazine (AVD) in patients with stage IIB, III, or IV HL (Deauville 1-3) and found that positron emission tomography (PET)-adapted de-escalation to AVD failed to demonstrate noninferiority compared with ABVD.
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?: