A Prospective Study Comparing Anti CD30 (Brentuximab Vedotin) With AVD Versus ABVD Chemotherapy Protocol Frontline Therapy in Patients With Advanced Classical Hodgkin Lymphoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
BV+AVD group
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.
干预措施: Brentuximab Vedotin + Doxorubicin, Vinblastine, and Dacarbazine (Drug)
ABVD group
Patients received Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (ABVD) drug regimen by intravenous infusion on Days 1 and 15 of each 28-day cycle.
干预措施: Doxorubicin, Bleomycin, Vinblastine, and Dacarbazine (Drug)
结局指标
主要结局
Progression-free survival
时间窗: 2 years post-procedure
Progression-free Survival was recorded.
次要结局
- 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)
研究者
Marwa Nazih Abdel Gawad
Assistant Lecturer of Clinical Oncology, Faculty of Medicine, Helwan University, Egypt.
Helwan University