KCT0008545尚未招募Unknown
A phase 1/2 study of the combination of venetoclax, rituximab and lenalidomide for relapsed or refractory primary central nervous system lymphoma
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1.Histologically confirmed PCNSL of DLBCL subtype with refractory or relapsed disease after at least one prior chemotherapy.
- •2.Prior treatment with first-line HD-MTX containing regimen
- •3.Age of = 18 years old
- •4.Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2
- •5.Adequate laboratory parameters within 14 days
- •- Absolute neutrophil count (ANC) = 1000/mm3 regardless of growth factor support
- •- Platelets = 75,000/mm3 independent of transfusion support
- •- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) = 3 x upper limit of normal (ULN)
- •- Total bilirubin = 1.5 x ULN unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin
- •- Estimated Glomerular Filtration Rate = 40 mL/min/1.73m2)
- •6.Provision of a signed written informed consent
- •7.Females of childbearing potential (FCBP) must:
- •a. Have a negative pregnancy tests prior to participating study. She must agree to ongoing pregnancy testing during the course of the study, and after end of study therapy. This applies even if the subject practices complete abstinence from heterosexual contact.
- •b. Either commit to complete abstinence from heterosexual contact (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, very effective contraception without interruption, 28 days prior to starting study therapy, during the study therapy (including dose interruptions), and for 12 months after discontinuation of study therapy.
- •*Very effective contraception
- •Intrauterine device
- •Bilateral atretic oviduct (A surgical procedure to prevent fertilization of an ovum)
- •Vasectomy of female subject’s male partner (Surgical success of vasectomy confirmed by medical evaluation)
- •Hormonal contraception associated with suppression of ovulation : Oral contraception pill (Estrogen/progestin pill or progestin alone pill), Skin contraceptive patch, intravaginal contraceptive ring, or subcutaneous contraceptive injection
- •Sexual abstinence (only abstinence from sexual intercourse with members of the opposite sex for the entire period of study-related risks is acceptable)
- •8.Male subjects must:
- •a. Practice complete abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 28 days following investigational product discontinuation, even if he has undergone a successful vasectomy.
- •b. Agree to not donate semen during investigational product therapy and for 28 days after discontinuation of investigational product therapy.
- •9.= 6 months life expectancy.
排除标准
- •1.History of another primary cancer (except for completely treated basal cell carcinoma, cervical carcinoma in situ, early gastric cancer, and thyroid cancer)
- •2.History of allogenic stem cell transplantation (patients with history of autologous stem cell transplantation can be enrolled to the study)
- •3.Prior history of solid organ transplantation or other cause of severe immunodeficiency.
- •4.Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator’s or Medical Monitor’s judgment, precludes the patient’s safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results
- •5.Recent major surgery within 4 weeks before the start of Cycle1 Day1
- •6.Known diagnosis of Human Immunodeficiency Virus infection
- •7.Active Hepatitis B Virus and Hepatitis C Virus infections requiring therapy.
- •8.Pregnant, breastfeeding, or possibly pregnant.
- •9.Known bleeding diathesis.
- •10.Alcohol or substance abuse disorder
- •11.Unable to swallow drug or malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach, or small bowel, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction
研究者
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