KCT0005598尚未招募未知
Brentuximab vedotin plus cisplatin, cytarabine, and dexamethasone in patients with relapsed or refractory Hodgkin’s lymphoma who are eligible for transplant
ational Cancer Center0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20?(Year) 至 70?(Year)（—）
- 性别
- All
入选标准
- •1. Histologically confirmed diagnosis of classical Hodgkin’s lymphoma. CD30 has to be positive
- •2.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
- •3. At least one measurable lesion(s)
- •- nodal lesion longest transverse diameter (LDi) = 1.5 cm
- •- extranodal lesion LDi = 1.0 cm)
- •4. Age 19 to 70 years
- •5. ECOG PS 0 - 2
- •6. 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
- •7. 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.
- •8. 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.
- •9.Written informed consent
排除标准
- •1. Non-Hodgkin’s lymphoma or nodular lymphocyte predominant Hodgkin’s lymphoma
- •2. 2 or more prior lines of treatment (Palliative radiotherapy or high-dose steroid therapy for symptom control are allowed)
- •3. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
- •4. Confirmed CNS involvement and/or symptomatic neurologic disease compromising normal activities of daily living or requiring medications
- •5. Patients who cannot tolerate high-dose therapy followed by ASCT described in the inclusion criteria 6.
- •6. 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
- •7. 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%
- •8. 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).
- •9. Hypersensitivity to the investigational products.
- •10.Peripheral neuropathy = Grade 2
- •11.Pregnant or nursing women
- •12.Human immunodeficiency virus (HIV)-positive
- •13.Active hepatitis B or hepatitis C infection
研究者
相似试验
进行中（未招募）
1 期
Venetoclax after chemotherapy R-BAC in high-risk elderly patients with mantle cell lymphomaMantle Cell Lymphoma in elderly patientsMedDRA version: 20.0 Level: LLT Classification code 10026799 Term: Mantle cell lymphoma NOS System Organ Class: 100000004864EUCTR2017-004628-31-ITFondazione Italiana Linfomi ONLUS130
进行中（未招募）
不适用
VINORELBINE, CARBOPLATIN AND TRASTUZUMAB IN ADVANCED HER-2 POSITIVE BREAST CANCER. A PHASE 2 STUDY - VinCaTBREAST CANCEREUCTR2006-003994-28-ITISTITUTO NAZIONALE PER LO STUDIO E LA CURA DEI TUMORI - FONDAZIONE G. PASCALE
进行中（未招募）
1 期
Brentuximab vedotin associated with chemotherapy in untreated patients with stage I/II unfavourable Hodgkin lymphomaMedDRA version: 17.1Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 100000004864Hodgkin LymphomaEUCTR2013-000182-37-ITYSARC170
招募中
2 期
BRENTUXIMAB VEDOTIN ASSOCIATED WITH CHEMOTHERAPY IN UNTREATED PATIENTS WITH STAGE I/II UNFAVOURABLE HODGKIN LYMPHOMA - A RANDOMIZED PHASE II LYSA-FIL-EORTC INTERGROUP STUDY BREACHCHEMOTHERAPYUNFAVOURABLE HODGKIN LYMPHOMA10025319NL-OMON55642YSARC14
进行中（未招募）
1 期
BRENTUXIMAB VEDOTIN ASSOCIATED WITH CHEMOTHERAPY IN UNTREATED PATIENTS WITH STAGE I/II UNFAVOURABLE HODGKIN LYMPHOMA - A RANDOMIZED STUDYntreated patients with histologically confirmed CD30+ classical Hodgkin lymphoma (stage I/II), aged > or = 18 and < or = 60 years old, with at least one unfavourable clinical pronostic factorMedDRA version: 20.0Level: LLTClassification code 10020328Term: Hodgkin's lymphomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: SOCClassification code 10029104Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps)System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-000182-37-DKYSARC170