NCT07171827

Anti-CD30 (Brentuximab Vedotin) With AVD Versus ABVD Chemotherapy Protocol Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Helwan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anti-CD30
• Brentuximab
• Doxorubicin
• Vinblastine
• Dacarbazine
• Frontline
• Advanced Classical Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Brentuximab Vedotin + Doxorubicin, Vinblastine, and Dacarbazine	Patients received Brentuximab Vedotin (BV)+ Doxorubicin, Vinblastine, and Dacarbazine (AVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle.
DRUG	Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine	Patients received Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle.

Timeline

• Start date: 2023-03-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2025-09-15
• Last updated: 2025-09-15

Locations

1 site across 1 country: Egypt