EUCTR2014-000835-17-ES进行中（未招募）1 期
PHASE I-II CLINICAL TRIAL FOR THE EVALUATION OF THE ROLE OF BRENTUXIMAB VEDOTIN PLUS ETOPOSIDE, SOLUMODERIN, HIGH DOSE ARA-C AND CIS-PLATIN IN THE TRANSPLANT AND POST-TRANSPLANT MANAGEMENT FOR PATIENTS WITH RELAPSED OR REFRACTORY CLASSICAL HODGKIN LYMPHOMA
GELTAMO (Grupo Cooperativo Español de Linfoma/Trasplante Autólogo de Médula Ósea)0 个研究点目标入组 66 人开始时间: 2014年5月8日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 66
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- •Each patient must meet all of the following inclusion criteria to be enrolled in this study:
- •1. Patients with histologically confirmed relapsed or refractory classical HL after first line chemotherapy. CD30 has to be positive in tumor cells based on any previous lymph node immunohistochemistry. Lymphocyte predominance (LP) Hodgkins Lymphoma with LP CD30 [neg] cells will be excluded.
- •2. Age 18 to 65 years. Patient >65 years old with ECOG =1 and absence of comorbidities will be included in the study if considered adequate by the investigator.
- •3. ECOG = 2.
- •4. No major organ dysfunction.
- •5. Written informed consent.
- •6. Biopsy at HL relapse or when refractoriness disease is diagnosed must be done prior to BV-ESHAP. If biopsy cannot be performed, tumor biopsy at initial diagnosis of HL must be available to be revised by reference pathologist if required.
- •7. Absence of prior history of other malignant diseases, except:
- •- Basal cell carcinoma of the skin or uterine in situ carcinoma adequately treated.
- •- Any curable neoplasia adequately treated that has achieved complete response and has remained in such status longer than 3 years.
- •8. 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 30 days after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
- •9. 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.
- •10. Karnofsky performance status =60.
- •11. Life-expectancy >3 months.
- •12. Baseline platelet count =75x109 /L (or 20 if due to Bone Marrow [BM] infiltration) absolute neutrophil count =1.5x109 /L (or 0.5 if due to BM infiltration), andhemoglobin must be = 8g/dL.
- •13. Meet the following pretreatment laboratory criteria at the Screening visit conducted within 28 days of study enrollment:
- •- Total Bilirubin: <1.5 times the upper limit of institutional laboratory normal, unless clearly related to the disease (Gilbert disease will be ruled out from this point).
- •- AST (SGOT):<3times the upper limit of institutional laboratory normal except liver infiltration.
- •- ALT (SGPT):<3 times the upper limit of institutional laboratory normalexcept liver infiltration.
- •- Serum creatinine must be < 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance > 40 mL/minute
- •- Serum sodium >130 mmol/L
- •14. Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
- •Are the trial s
排除标准
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1. Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment).
- •2. Serious medical or psychiatric illness likely to interfere with participation in this clinical study.
- •3. Patients that have been treated previously with anti-CD30 monoclonal antibodies cannot be enrolled in the study.
- •4. Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, congestive heart failure (NYHA III-IV), severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any EKG abnormality
- •at Screening has to be documented by the investigator as not medically relevant.Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%.
- •5. Peripheral neuropathy or neuropathic pain grade 2 or higher as defined by NCI CTCAE version 4
- •6. Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML
- •7. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications
- •8. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximabvedotin.
- •9. Women who are pregnant. Women who are breast-feeding and do not consent to discontinue breast-feeding. Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. Women of childbearing potential must have a negative pregnancy test at screening and cycle 1 day 1 prior to the first dose of brentuximabvedotin.
- •10. Treatment with any known non-marketed drug substance or experimental therapy within the longer of 5 terminal half-lives or 4 weeks prior to enrollmentor currently participating in any other interventional clinical study
- •11. Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment within two weeks prior to first study drug dose such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active Hepatitis C.
- •12. History of significant cerebrovascular disease in the past 6 months or ongoing event with active symptoms or sequelae
- •13. Known HIV positive
- •14. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease which in the opinion of the investigator may represent a risk for the patient.
- •15. Positive serology for hepatitis B (HBV) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positi
研究者
相似试验
进行中（未招募）
1 期
A RANDOMIZED PHASE 2 CLINICAL TRIAL TO EVALUATE THE ACTIVITY OF ATRA IN COMBINATION WITH ANASTROZOLE IN PRE-OPERATIVE PHASE OF OPERABLE HR-POSITIVE/HER2-NEGATIVE EARLY BREAST CANCEREBC ATRA TRIAPatients with newly, untreated, resectable HR+/HER2- eBCs, suitable for pre-operative therapy with anastrozoleMedDRA version: 20.0Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001856-36-ITIRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI112
进行中（未招募）
不适用
Ensayo clínico de Fase II para la evaluación del tratamiento secuencial de Interleukina 2 e Interferón alfa subcutáneo seguido de Sorafenib (BAY 43-9006) en pacientes con carcinoma de células renales (CCR) no resecable y/o metastásico - ESTUDIO RENAEUCTR2005-003697-25-ESInstitut de Recerca del Hospital de la Santa Creu i Sant Pau41
进行中（未招募）
1 期
EVALUATING THE EFFECT OF PIRFENIDONE COMPARED WITH PLACEBO IN PULMONARY FIBROSIS POST-COVID 19EUCTR2020-002518-42-ESIDIBE148
尚未招募
2 期
Effect Of Amalakyadi Kwath in Urinary Tract Infection.CTRI/2022/01/039665PRITEE SANJAY SHEJWA
尚未招募
2 期
To study the Effect of Ayurvedic Kalpa in AnaemiaCTRI/2022/01/039553Dr Sanket Anilrao Timande