EUCTR2017-001060-38-DK进行中（未招募）1 期
Venetoclax, lenalidomide and rituximab in patients with relapsed/refractory mantle cell lymphoma. - VALERIA
ordic Lymphoma Group0 个研究点目标入组 83 人开始时间: 2018年10月31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
- 83
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.Age >18 years
- •2.Histologically confirmed (according to the WHO 2016 classification) mantle cell lymphoma stage I-IV
- •a.Who have received at least 1 prior rituximab-containing chemotherapy regimen, with documented relapse or disease progression following
- •the last anti-MCL treatment
- •b.Are not considered to be candidates for chemotherapy due to frailty or comorbidity
- •4.At least 1 measurable site of disease (>1.5 cm long axis)
- •5.WHO performance status 0 – 3
- •6.Written informed consent.
- •7.Female subjects of childbearing potential must (see page 52 for definition of not fertile):
- •a.Understand that the study medication is expected to be teratogenic
- •b.Agree to use, and be able to comply with, highly effective contraception without interruption, 4 weeks before starting study drug,
- •throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has
- •amenorrhoea.
- •c.All fertile women must agree to perform monthly pregnancy tests while on study medication and until 4 weeks after completion of study
- •drug. Tests must have a minimum sensitivity of 25 mIE/ml and be medically witnessed
- •d.Highly effective contraception include:
- •e.Implant*
- •f.Levonorgestrel-releasing intrauterine system (IUS)*
- •g.Medroxyprogesterone acetate depot
- •h.Tubal sterilisation
- •i.Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses
- •j.Ovulation inhibitory progesterone-only pills (i.e., desogestrel)
- •NB! Patients using a hormonal method, must also use a second barrier method.
- •k.Sexual abstinence (if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The
- •reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle of the subject).
- •8.Male subjects must
- •a.Agree to use condoms throughout study drug therapy, during any dose interruption and for one week after cessation of study therapy if
- •their partner is of childbearing potential and has no contraception.
- •b.Agree not to donate semen during study drug therapy and for one week after end of study drug therapy.
- •9.All subjects must
- •a.Agree to abstain from donating blood while taking study drug therapy and for one week following discontinuation of study drug therapy.
- •b.Agree not to share study medication with another person and to return all unused study drug to the investigator
- •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 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 53
排除标准
- •a.Chemotherapy or radiotherapy within 3 weeks
- •b.Therapeutic antibodies or BTK inhibitors within 4 weeks
- •c.Radioimmunotherapy within 10 weeks
- •d.Major surgery within 4 weeks of inclusion in this trial.
- •2.Previous treatment with venetoclax
- •3.Impaired liver function: AST and ALT >3.0 × the upper normal limit (ULN) of institution's normal range; Bilirubin > 1.5 × ULN. Subjects with
- •Gilbert's Syndrome may have a bilirubin > 1.5 × ULN, per discussion between the investigator and medical monitor. Elevated Bilirubin due
- •to haemolytic anemia or caused by lymphoma, is not an exclusion criterion.
- •4.Absolute neutrophil count (ANC) <1.0x 109, unless caused by bone marrow infiltration by lymphoma.
- •5.Platelet count <60 x 109, unless caused by bone marrow infiltration by lymphoma.
- •6.Creatinine clearance below 50 ml/min (Cockcroft-Gault)
- •7.Known CNS lymphoma.
- •8.Heart failure in NYHA stage IV or other serious CVD
- •9.Pulmonary failure (ex chronic disease with hypoxemia)
- •10.Active serious infections such as hepatitis B or C and HIV
- •11.Conditions with serious immunocompromised state
- •12.Breastfeeding women must be excluded or stop breastfeeding
- •13.Other active malignancy.
- •14.Psychiatric illness or condition which could interfere with the subjects’ ability to understand the requirements of the study.
- •15.Requirement of corticosteroid therapy at a dose >10 mg prednisolone/day.
- •16.Hypersensitivity to venetoclax, lenalidomide or rituximab, or HACA against rituximab.
研究者
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