EUCTR2012-004246-15-BE进行中（未招募）1 期
A Phase II study of oral JAK1/JAK2 inhibitor INC424 in adult patients with relapsed/refractory classical Hodgkin’s lymphoma
YSARC0 个研究点目标入组 33 人开始时间: 2013年5月22日最近更新:
适应症
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
- 33
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
- •- Patients = 18 years with classical HL relapsing or refractory after at least 1 prior systemic therapy. Patients must have relapsed after high-dose therapy with ASCT, or have been deemed ineligible for high-dose therapy with ASCT
- •- ECOG performance status < 3
- •- Measurable nodal disease: 1 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan (MRI is allowed only if CT scan cannot be performed).
- •- Patient has the following laboratory values:
- •Absolute neutrophil count (ANC) = 1.0 x 109/L [SI units 1.0 x 109/L]
- •Platelet count = 75 x 109/L
- •Serum creatinine = 1.5 x upper limit of normal (ULN)
- •Serum bilirubin = 1.5 x ULN (or = 3.0 x ULN, if patient has Gilbert syndrome)
- •AST/SGOT and/or ALT/SGPT = 2.5 x ULN or = 5.0 x ULN if the transaminase elevation is due to liver disease involvement
- •- Signed written informed consent
- •- Life expectancy = 3 months
- •- Corrected QT interval < 450 mSec
- •- Men and women of childbearing potential must agree to use an adequate method of contraception during the study treatment and for at least 1 week after the last study drug administration
- •- The patient must be covered by a social security system (for inclusions in France)
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 8
排除标准
- •- Previous treatment with ruxolitinib or another JAK inhibitor
- •- Contraindication to ruxolitinib
- •- Patient received chemotherapy or radiotherapy or any investigational drug within 14 days prior to starting study drug or whose side effects of such therapy have not resolved to = grade 1
- •- Patient treated with allogeneic hematopoietic stem cell transplant who is currently on, or has received immunosuppressive therapy within 90 days prior to start of screening and/or have = Grade 2 graft versus host disease (GvHD).
- •- Patient with prior history of another active primary malignancy = 2 years before study entry, with the exception of non-melanoma skin cancer, and carcinoma in situ of uterine cervix
- •- Any serious active disease or co-morbid medical condition that, according to the investigator’s decision, will substantially increase the risk associated with the subject’s participation in the study.
- •- 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.
- •- HIV, HCV or HTLV serology positivity and/or documented infection with active hepatitis B
- •- Prior history of CNS involvement with lymphoma
- •- Pregnant or lactating woman
- •- Adult patient unable to provide informed consent because of intellectual impairment, any serious medical condition, laboratory abnormality or psychiatric illness.
研究者
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