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

NCT07171827 | Completed

• 1 other identifier: 40-2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Progression-free survival

  Progression-free Survival was recorded.

  2 years post-procedure

Secondary Outcomes (3)

• Overall response rate

  30 days after the end of treatment

• Overall survival

  2 years post-procedure

• Incidence of adverse events

  30 days after the end of frontline therapy

Study Arms (2)

BV+AVD group

EXPERIMENTAL

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: Brentuximab Vedotin + Doxorubicin, Vinblastine, and Dacarbazine

ABVD group

EXPERIMENTAL

Patients received Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle.

Drug: Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine

Interventions

Brentuximab Vedotin + Doxorubicin, Vinblastine, and Dacarbazine DRUG

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.

BV+AVD group

Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine DRUG

Patients received Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle.

ABVD group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18- 70 Years.
• Histopathology: confirmed classical Hodgkin Lymphoma according to the current World Health Organization (WHO) classification. CD30 positive by immunohistochemistry.
• Stage III or IV Hodgkin lymphoma (HL) by the Ann Arbor classification system.
• Treatment-naïve.
• Laboratory:
• complete blood count: absolute neutrophil counts (≥1500 per cubic millimeter), platelet counts (≥75,000 per cubic millimeter), and hemoglobin levels (≥8 g per deciliter) (except for patients with involvement of the marrow).
• liver function test: total bilirubin level \<1.5 times the upper limit of normal and alanine aminotransferase or aspartate aminotransferase levels \<3 times the upper limit of normal.
• kidney function test: serum creatinine level, \<2.0 mg per deciliter or creatinine clearance or calculated creatinine clearance, \>40 ml per minute.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

You may not qualify if:

• Histopathology: Nodular lymphocyte predominant Hodgkin lymphoma and non-Hodgkin lymphoma.
• Cerebral/meningeal disease.
• Prior treatment with chemotherapy, radiotherapy, or any immunotherapy within 12 weeks of first study drug dose.
• Known human immunodeficiency virus (HIV) positive, known hepatitis B surface antigen-positive, or known active hepatitis C infection.
• Known organ failure.
• Cardiac: left ventricular ejection fraction \< 50%, myocardial infarction within 2 years of randomization or current uncontrolled cardiovascular conditions, including arrhythmias, congestive heart failure, angina, evidence of acute ischemia, or active conduction system abnormalities.
• Female patients who are breastfeeding or having a positive serum pregnancy test during the randomization period or on day 1 before starting treatment.
• Neurotoxicity, including symptomatic neurologic disease, comprising normal daily activities, any sensory or motor peripheral neuropathy.
• Pulmonary diffusion capacity \>25 % lower than predicted value as retrieved by pulmonary function test for each patient before randomization.
• Known hypersensitivity to recombinant proteins, murine proteins, or any component of the included drugs formulation.

Sponsors & Collaborators

• Helwan University: lead

Study Sites (1)

Helwan University

Helwan, 11795, Egypt

Location

MeSH Terms

Interventions

Brentuximab Vedotin; Doxorubicin; Vinblastine; Dacarbazine; Bleomycin

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Triazenes; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Glycopeptides; Glycoconjugates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Clinical Oncology, Faculty of Medicine, Helwan University, Egypt.

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 15, 2025
• Study Start: March 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)