EUCTR2016-000548-33-FR进行中（未招募）1 期
Phase II study to evaluate the efficacy of upfront obinutuzumab in mantle cell lymphoma patients treated by DHAP followed by autologous transplantation plus obinutuzumab maintenance then MRD driven maintenance
YSARC0 个研究点开始时间: 2016年10月10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
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
- •Age = 18 and age = 65
- •Histologically confirmed (according to the WHO classification) mantle cell lymphoma. The diagnosis has to be confirmed by phenotypic expression of CD5, CD20 and cyclin D1 or the t(11;14) translocation.
- •Bone marrow aspiration performed at inclusion for MRD analyses
- •Eligible for autologous stem cell transplant
- •Previously Uuntreated MCL
- •Stage Ann Arbor II-IV in need of treatment
- •ECOG performance status of 0 – 2
- •Life expectancy of more than 3 months
- •Written informed consent
- •Patient covered by any social security system
- •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 83
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Severe cardiac disease: NYHA grade 3-4
- •Impaired liver (ALAT/ASAT = 2.5ULN, bilirubin = 1.5ULN), renal (calculated creatinine clearance < 50ml/min) or other organ function which will interfere with the treatment, if not related to lymphoma.
- •History of chronic liver disease
- •Hepatic veno-occlusive disease or sinusoidal obstruction syndrome
- •Any of the following laboratory abnormalities, if not result of a BM infiltration:
- •- Absolute neutrophils count (ANC) <1,500 /mm3 (1.5 x 109/L)
- •- Platelet counts < 75,000/mm3 (75 x 109/L)
- •Pregnancy/Nursing mothers
- •Fertile men or women of childbearing potential unless:
- •- surgically sterile or = 2 years after the onset of menopause
- •- willing to use a highly effective contraceptive method (Pearl Index <1) such as oral contraceptives, intrauterine device, sexual abstinence or barrier method of contraception in conjunction with spermicidal jelly during study treatment and in female patients for 18 months after end of antibody treatment
- •Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible. Patients with a malignancy that has been treated but not with curative intent will also be excluded, unless the malignancy has been in remission without treatment for = 5 years prior to enrollment
- •Known seropositivity for HIV, HCV or other active infection uncontrolled by treatment.
- •Viral infection with hepatitis B virus (HBV) defined as hepatitis B surface antigen (HBsAg) positive and/or Hepatitis B core antibody (anti-HBc) positive
- •Note: Patients who are immune due to hepatitis B vaccination or natural infection (HBs Ag and anti-HBc negative, anti-HBs positive) are eligible. But the patients who are immune due to hepatitis B natural infection should consult liver disease experts before start of treatment and should be monitored and managed following local medical standards to prevent hepatitis reactivation
- •Prior history of Progressive Multifocal Leukoencephalopathy (PML)
- •Prolonged B cell depletion
- •Vaccination with a live vaccine a minimum of 28 days prior to inclusion
- •History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. Known sensitivity or allergy to murine products
- •Psychiatric illness or condition which could interfere with their ability to understand the requirements of the study.
- •Person deprived of his/her liberty by a judicial or administrative decision
- •Person hospitalized without consent
- •Adult person under legal protection
研究者
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