EUCTR2014-003320-51-IT进行中（未招募）1 期
A phase 1/2 clinical trial to assess safety and efficacy of a new treatment for Hodgkin lymphoma's disease combining Adcetris¿ and Levact¿ in Old patients - HALO
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- 性别
- All
入选标准
- •1.Patients with advanced classical Hodgkin Lymphoma according to the World Health Organization classification. All Hasenclever
- •IPS prognostic groups accepted
- •2.Stages IIB to IV B
- •3.Age 60-80 years included
- •4.Patient not previously treated
- •5.ECOG = 2
- •6.Patient with adequate organ function:
- •Absolute neutrophil count (ANC) = 1.5 x 109/L
- •Haemoglobin = 9 g/dL
- •Platelets (PTL) = 100 x 109/L
- •AST - ALAT = 2.5x ULN
- •Bilirubin = 1.5 x ULN
- •Creatinine < 150 µmol/l (or 1.7 mg/dl)
- •7.Male patients, even if surgically sterilized, (i.e., status post vasectomy) and women of childbearing potential 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.
- •Contraception as described above is not a requirement if the female patient’s postmenopausal status is documented (has had no
- •menstrual period for at least 12 consecutive months)
- •8.Information delivered to patient and voluntary written informed consent must be given before performance of any study-related
- •procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time
- •without prejudice to future medical care.
- •9.Patient affiliated with a health insurance system.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 45
排除标准
- •1.Patients aged less than 60 years.
- •2.Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another
- •malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are
- •not excluded if they have undergone complete resection.
- •3.Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of PML.
- •4.Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication.
- •5.Symptomatic sensory or motor peripheral neuropathy.
- •6.Concurrent use of other investigational agents. In case of previous participation to a Clinical trial, a period of 30 days will be
- •observed after the end of the previous Clinical Trial and before the inclusion in HALO study
- •7.Chemotherapy, biologics, and/or other treatment with immunotherapy not completed at least 4 weeks prior to first dose of study
- •8.Patient who had major surgery less than 30 days before start of treatment
- •9.Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug
- •10.Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of BV.
- •11.Patient presenting an uncontrolled infectious disease, including active HBV infection defined by either detection of HBs Antigen
- •or presence of anti HBc antibody without detectable anti HBs antibody or HIV or HCV serology positivity. In case of HBc positive
- •serology, a PCR could be performed in order to determine viral load. Patients with viral load defined as negative could be
- •oA prophylactic treatment will be strongly recommended (see HALO Study protocol, paragraph 6.2.3, page 36)
- •12.Patient with history of poor compliance or current or past psychiatric conditions or severe acute or chronic medical conditions,
- •or laboratory abnormalities that would interfere, in the judgment of the investigator and/or sponsor, with the ability to comply with
- •the study protocol.
- •13.Patients with uncompensated diabetes mellitus and fasting glucose levels over 180 mg/dl.
- •14.Known history of any of the following cardiovascular conditions
- •Myocardial infarction within 2 years of enrollment
- •New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 12)
- •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
- •15.Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50%
- •16.People particularly vulnerable including:
- •Person deprived of liberty
- •Adult patient entitled to protection of law
研究者
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