NCT05243693招募中2 期
Brentuximab Vedotin Plus Cisplatin, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Hodgkin's Lymphoma Who Are Eligible for Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete response rate
研究概览
简要总结
< STUDY DESIGN > This study is a multi-center phase II trial in patients with relapsed or refractory Hodgkin's lymphoma after first-line treatment.
< Treatment Schedule >
- Induction phase
- Patients who sign the informed consent form (ICF) receive BV-DHAP induction therapy within 21 days.
- Tumor response is evaluated following 2 cycles of induction therapy. As a result of tumor response evaluation, PD (progressive disease) means a withdrawal from the study; and CR (complete response), PR (partial response), or SD (stable disease) requires peripheral blood stem cell collection (PBSCC) followed by additional one cycle of induction therapy.
- Following a total of 3 cycles of induction therapy, tumor response is evaluated again. If the result turns out to be CR or PR, treatment goes on to autologous stem cell transplant (ASCT). SD or PD means a withdrawal from the study.
- Consolidation phase - ASCT is performed in accordance with a protocol based on the relevant site's policy.
详细描述
< STUDY DESIGN > This study is a multi-center phase II trial in patients with relapsed or refractory Hodgkin's lymphoma after first-line treatment.
< Treatment Schedule >
- Induction phase
- Patients who sign the informed consent form (ICF) receive BV-DHAP induction therapy within 21 days.
Study Drug Dosage will be as follows; Brentuximab vedotin: 1.8 mg/kg IV over 30 minutes D1 Cisplatin* 100 mg/m2 + NS 1000 mL CIV over 24 hours D1 Cytarabine* 2.0 g/m2 + 5% DW 250 mL IV over 3 hours twice a day D2 Dexamethasone 40 mg IV or PO D1-4
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed diagnosis of classical Hodgkin's lymphoma. CD30 has to be positive
- •Refractory to the first-line treatment or relapse after the first-line treatment (radiologically confirmed)
- •Deauville score 5 as a result of the restaging PET-CT after 2 to 3 cycles of ABVD treatment
- •Deauville score 4 to 5 even after the completion of ABVD treatment or radiotherapy and are not candidates for ISRT (involved site radiation therapy)
- •Radiologically confirmed relapsed after achieving CR
- •At least one measurable lesion(s)
- •nodal lesion longest transverse diameter (LDi) ≥ 1.5 cm
- •extranodal lesion LDi ≥ 1.0 cm)
- •Age 19 to 70 years
- •ECOG PS 0 - 2
- •Appropriate organ functions to tolerate the protocol treatment and ASCT Absolute Neutrophil Count (ANC) ≥ 1.5 x 10^9/L Platelets ≥ 75 x 10^9/L Hemoglobin ≥ 8.0 g/dL Serum Creatinine ≤ 1.5 x upper limit normal (ULN) Serum Bilirubin ≤ 1.5 x ULN AST and ALT ≤ 3 x ULN Corrected diffusing capacity for carbon monoxide (DLCO) ≥50 percent
- •Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
- •Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
- •Written informed consent
排除标准
- •Non-Hodgkin's lymphoma or nodular lymphocyte predominant Hodgkin's lymphoma
- •2 or more prior lines of treatment (Palliative radiotherapy or high-dose steroid therapy for symptom control are allowed)
- •Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
- •Confirmed CNS involvement and/or symptomatic neurologic disease compromising normal activities of daily living or requiring medications
- •Patients who cannot tolerate high-dose therapy followed by ASCT described in the inclusion criteria
- •Patients with severe or uncontrolled medical conditions, abnormal laboratory findings, or psychiatric disorders. For example, i. severely impaired pulmonary function as defined as spirometry and DLCO (diffusing capacity of the lung for carbon monoxide) that is 50% or less of the normal predicted value and/or O2 saturation that is 90% or less at rest on room air ii. any active (acute or chronic) or uncontrolled infection/disorders that impair the ability to evaluate the patient or for the patient to complete the study iii. nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by this study drug, such as severe hypertension that is not controlled with medical management and thyroid abnormalities when thyroid function cannot be maintained in the normal range by medication iv. creatinine clearance < 30 mL/min
- •Known history of any of the following cardiovascular conditions i. Myocardial infarction within 2 years of enrollment ii. New York Heart Association (NYHA) Class III or IV heart failure iii. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities iv. Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
- •Synchronous or metachronous malignant tumor other than HL within 5 years (except for adequately treated basal cell carcinoma (BCC) or squamous cell carcinoma (SCC) of the skin, carcinoma in situ of the uterine cervix, adequately resected differentiated thyroid cancer, intraepithelial carcinoma of the neck or breast, or prostate cancer that can be monitored for progress status without any treatment).
- •Hypersensitivity to the investigational products.
- •Peripheral neuropathy ≥ Grade 2
- •Pregnant or nursing women
- •Human immunodeficiency virus (HIV)-positive
- •Active hepatitis B or hepatitis C infection
研究组 & 干预措施
Brentuximab vedotin and DHAP
Experimental
A clinical study of safety and efficacy of treatment with Brentuximab vedotin and DHAP in patients with relapsed/refractory Hodgkin lymphoma
干预措施: Brentuximab vedotin (Drug)
结局指标
主要结局
Complete response rate
时间窗: up to 3 months
Tumor response is evaluated following 3 cycles (each cycle is 21 days) of BV + DHAP induction therapy
次要结局
- Progression free survival(up to 24 months)
- Overall survival(up to 24 months)
- Overall response rate(up to 3 months)
- Safety profiles(up to 3 months)
研究者
Hyeon-Seok Eom, MD, PhD
Professor
National Cancer Center, Korea
研究点 (1)
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