EUCTR2018-003526-88-IT进行中（未招募）1 期
Efficacy and safety of Carfilzomib in combination with Ibrutinib vs. Ibrutinib alone in Waldenström’s Macroglobulinemia - CZAR-1
IVERSITäTSKLINIK ULM0 个研究点目标入组 184 人开始时间: 2021年8月30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
- 184
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
- •Proven clinicopathological diagnosis of WM as defined by consensus panel one of the Second IWWM4.
- •De novo or relapsed / refractory WM independent of the genotype.
- •Patients must have at least one of the following criteria to start study treatment as as defined by the protocol criteria.
- •World Health Organization (WHO) / ECOG performance status = 2.
- •Left ventricular ejection fraction = 40% as assessed by transthoracic echocardiogram (TTE).
- •Age = 18 years (male and female),
- •Life expectancy > 3 months in the opinion of the investigator, adequate laboratory values.
- •Baseline platelet count = 50 x109/L, absolute neutrophil count = 0.75 x 109/L (if not due to BM infiltration by the lymphoma).
- •Meet the following pre-treatment laboratory criteria at the screening visit conducted within 30 days prior to randomization:
- •¿ ASAT (SGOT): < 3.0 times the ULN.
- •¿ ALAT (SGPT): < 3.0 times the ULN.
- •¿ Total Bilirubin: < 1.5 times the ULN, unless clearly related to the disease (except if due to Gilbert’s syndrome).
- •¿ Serum creatinine: = 1.5 times the ULN
- •Females of childbearing potential (FCBP), i.e. fertile, following menarche and until becoming postmenopausal, must agree to use a highly effective method of birth control for the duration of the therapy up to 6 months after end of therapy with Carfilzomib or Ibrutinib.
- •Men must agree not to father a child for the duration of therapy and 6 months after (use of a condom) and must agree to advice a female
- •partner to use a highly effective method of birth control. Males must refrain from sperm donation for at least 6 months after the last dose of Carfilzomib or Ibrutinib.
- •Each patient must sign an informed consent form in a fluent language of the patient indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study. Patients must be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- •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 92
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 92
排除标准
- •Previous treatments with following substances Prior exposure to Ibrutinib or other BTK inhibitors and Prior exposure to Carfilzomib
- •Serious medical or psychiatric illness
- •Active HIV, HBV or HCV infection
- •Central Nervous System involvement by lymphoma.
- •History of a non-lymphoid malignancy except
- •Uncontrolled illness including, but not limited to. (See the protocol).
- •Recent major surgery within 30 days prior to randomization.
- •Known cirrhosis
- •Approved or investigational anticancer treatment within 21 days prior to randomization.
- •Glucocorticoid therapy within 14 days prior to randomization
- •Focal radiation therapy within 7 days prior to randomization.
- •Contraindication to any of the required concomitant drugs or supportive treatments, including hypersensitivity to antiviral drugs.
- •Hypersensitivity to the active substances or to any of the excipients of the investigational medicinal products
- •Active infection
- •Uncontrolled hypertension
- •History of stroke or intracranial hemorrhage
- •Known interstitial lung disease.
- •Pleural effusions.
- •Infiltrative pulmonary disease, known pulmonary hypertension.
- •Known chronic obstructive pulmonary•
- •Known severe persistent asthma
- •Autologous or allogeneic stem cell transplant less
- •Vaccination with
- •Patients who require strong or moderate inducers or inhibitors for cytochrome
- •Patients who have an uncontrolled bleeding disorder or require an anticoagulant
- •History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or sponsor, if consulted, would pose a risk to patient safely or interfere with the study evaluation, procedures or completion.
- •Patient is a woman who is pregnant or breastfeeding (and do not consent to discontinue breast-feeding) or planning to become pregnant while enrolled in this study or within 6
- •months after the last study treatment.
- •Vulnerable patients, e.g. patients who are incapable of giving informed consent (severe dementia or psychosis, patients kept in detention).
- •Participation in another interventional clinical study within 30 days before randomization in this study.
研究者
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