EUCTR2017-003909-17-DK进行中（未招募）1 期
Randomized Phase 3 Study evaluating the Efficacy and the Safety of Oral Azacitidine (CC-486) compared to Investigator’s Choice Therapy in Patient with Relapsed or Refractory Angioimmunoblastic T cell Lymphoma - ORACLE
YSARC0 个研究点目标入组 86 人开始时间: 2020年1月24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
- 86
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
- •- = 18 years
- •- local diagnosed peripheral T cell lymphoma (PTCL) with T-follicular helper (TFH) phenotype according to the criteria of the latest WHO classification based on a surgical lymph node biopsy including any one
- •Angioimmunoblastic T cell lymphoma (AITL)
- •Follicular T cell lymphoma
- •Nodal peripheral T-cell lymphoma with TFH phenotype
- •with a documented expression of minimum two TFH markers among CD10, CXCL13, PD1, ICOS and BCL6
- •- ECOG performance status 0 to 3
- •- Relapsed (after partial or complete response) or refractory AITL after at least one line of systemic therapy
- •- Meet the following lab criteria:
- •ANC = 1,5 x 109/L (= 1 x 109/L if BM involvement by lymphoma)
- •Platelet = 75 x 109/L (= 50 x 109/L if BM involvement by lymphoma)
- •Hemoglobin = 8 g/dL.
- •- Anticipated life expectancy at least 3 months
- •- At least one measurable lesion on CT greater than 1.5 cm in the longest diameter for nodal lesions and than 1.0 cm in the longest diameter for extranodal lesions.
- •- Female patient of childbearing potential (FCBP) with two negative pregnancy tests : serum pregnancy test at Screening and negative serum or urine pregnancy test within 72 hours prior to starting treatment with study treatment, who agrees to practice true abstinence or to use highly effective methods of contraception and who agrees to abstain from breastfeeding
- •- Male patient who agrees to practice true abstinence from heterosexual contact or to use highly effective methods of contraception and who agrees not to give semen or sperm
- •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 37
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 49
排除标准
- •- Clinical evidence of central nervous system involvement by lymphoma.
- •- Any significant medical conditions, laboratory abnormality or psychiatric illness likely to interfere with participation in this clinical study
- •- Uncontrolled systemic fungal, bacterial, or viral infection
- •- Known Human Immunodeficiency Virus (HIV) or Hepatitis C Virus (HCV) infection, or evidence of active Hepatitis B Virus (HBV) infection defined as:
- •- HBs Ag positive
- •- HBs Ag negative, anti-HBs antibody positive and/or anti-HBc antibody positive with detectable viral DNA
- •- Impaired renal function (calculated MDRD or Cockcroft-Gault Creatinine Clearance < 30 ml/min) or impaired liver function tests (Serum total bilirubin level > 2.0 mg/dl [34 µmol/L] (except in case of Gilbert’s Syndrome, or documented liver or pancreatic involvement by lymphoma), Serum transaminases (AST or ALT) > 3 upper normal limits) unless they are related to the lymphoma.
- •- Active malignancy other than the one treated in this research, except
- •a. Basal or squamous cell carcinoma of the skin
- •b. Carcinoma in situ of the cervix
- •c. Carcinoma in situ of the breast
- •d. Incidental histologic finding of prostate cancer (T1a or T1b) using the tumor, nodes, metastasis [TNM] clinical staging system
- •e. Early-stage gastric cancer suitable for endoscopic mucosal resection or endoscopic submucosal dissection
- •- Treatment with any investigational drug within 5 half-lives before planned first cycle of study treatment and during the study.
- •- Prior exposure to azacitidine and/ or any other demethylating agent (eg, decitabine)
- •- Prior exposure to planned study treatment investigator’s choice therapy
- •- Concurrent use of corticosteroids unless the patient is on a stable or decreasing dose for = 1 week prior to informed consent form signature
- •- Known or suspected hypersensitivity to active substance or to any of the excipients.
- •- Pregnant, planning to become pregnant, or lactating woman
- •- Candidate for hematopoietic stem cell transplantation
- •- History of active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the oral azacitidine and/or predispose the patient to an increased risk of gastrointestinal toxicity per investigator’s decision. Any condition causing inability to swallow tablets.
- •- Significant active cardiac disease within the previous 6 months
研究者
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