Status:
COMPLETED
Anti-CD30 (Brentuximab Vedotin) With AVD Versus ABVD Chemotherapy Protocol Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
Lead Sponsor:
Helwan University
Conditions:
Anti-CD30
Brentuximab
Eligibility:
All Genders
18-70 years
Phase:
NA
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 Dacarba...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07171827
Start Date
March 1 2023
End Date
February 1 2025
Last Update
September 15 2025
Active Locations (1)
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1
Helwan University
Helwan, Egypt, 11795