EUCTR2020-002622-87-DE进行中（未招募）1 期
A phase II trial of belimumab in combination withrituximab/venetoclax in patients with refractory orrelapsed chronic lymphocytic leukemia
niversity Hospital Tuebingen0 个研究点目标入组 120 人开始时间: 2021年6月2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
- 120
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.Male or female =18 years of age.
- •2.Diagnosis of CLL/SLL established according to iwCLL criteria
- •3.Refractory or relapsed CLL that warrants treatment (according to modified criteria for initiation of therapy (Hallek et al., 2018)):
- •a.Massive (ie, lower edge of spleen =6 cm below the left costal margin), progressive, or symptomatic splenomegaly, or
- •b.Massive (ie, =10 cm in the longest diameter), progressive, or symptomatic lymphadenopathy, or
- •c.Progressive lymphocytosis in the absence of infection, with an increase in blood ALC=50% over a 2-month period or lymphocyte doubling time of <6 months (as long as initial ALC was =30,000/L), or
- •d.Autoimmune anemia and/or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy, or
- •e.Constitutional symptoms, defined as any one or more of the following disease-related symptoms or signs occurring in the absence of evidence of infection:
- •i.Unintentional weight loss of =10% within the previous 6 months, or
- •ii.Significant fatigue (=Grade 2), or
- •iii.Fevers >38.0°C for =2 weeks, or
- •iv.Night sweats for >1 month.
- •4.CLL relapsing after any line of treatment that included radiotherapy, chemotherapy, immunotherapy, or small molecules. Patients who relapse after a previous therapy with venetoclax can be included in the study in case of a late relapse (i.e. >18 months after venetoclax was discontinued.
- •5.Discontinuation of all therapy (including radiotherapy, chemotherapy, immunotherapy, or small molecules) for the treatment of CLL =2 weeks before study treatment excluding systemic corticosteroids for symptomatic control.
- •6.All acute toxic effects of any prior antitumor therapy resolved to Grade =1 before treatment (with the exception of alopecia [Grade 1 or 2 permitted], neurotoxicity [Grade 1 or 2 permitted], or bone marrow parameters [any of Grade 1, 2, 3, or 4 permitted]).
- •7.Eastern Cooperative Oncology Group [ECOG] < 3.
- •8.Required baseline laboratory data (within 4 weeks prior to treatment):
- •Serum total bilirubin =1.5 x ULN (unless directly attributable to CLL disease or to Gilbert’s Syndrome)
- •ALT/AST =2.5 x ULN
- •Renal creatinine clearance >30 ml/min
- •Neutrophile count >1.000/µl (unless directly attributable to the CLL disease)
- •9.Negative serological Hepatitis B and C test or negative PCR in case of positive serological test without evidence of an active infection, negative HIV test within 6 weeks prior to treatment.
- •10.Written informed consent of the subject
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •1.(Suspicion of) transformation of CLL (i.e. Richter’s transformation, pro-lymphocytic leukemia) or central nervous system (CNS) involvement
- •2.Early relapse (i.e <18 months) after any line of treatment that included venetoclax.
- •3.IgG < 4 g/L under substitution of immunoglobulins
- •4.Malignancies other than CLL currently requiring systemic therapies
- •5.Evidence of active systemic bacterial (e.g. tuberculosis), fungal, or viral infection (e.g., CMV) at the time of initiation of therapy.
- •6.Confirmed progressive multifocal leuk-encephalopathy (PML)
- •7.Known history of drug-induced liver injury (DILI), chronic/active hepatitis C (HCV), chronic/active hepatitis B (HBV).
- •8.Requirement of therapy with strong CYP3A4 inhibitors/ inducers or anticoagulant with phenprocoumon (marcumar) or other vitamin K-antagonists
- •9.Active inflammatory bowel disease.
- •10.History of prior allogeneic bone marrow or organ transplantation.
- •11.Ongoing immunosuppressive therapy. Subjects may use topical, enteric, or inhaled corticosteroids as therapy for comorbidities and systemic steroids for autoimmune anemia and/or thrombocytopenia. Ongoing use of low-dose systemic corticosteroids (=5 mg/day of methylprednisolone or equivalent) for rheumatologic conditions is permitted.
- •12.History of primary immunodeficiency
- •13.Concurrent participation in another therapeutic clinical trial.
- •14.History of serious suicide risk including any suicidal behaviour in the last 6 months
- •15.Live vaccination 30 days prior to treatment.
- •16.Hypersensitivity known from medical history to one of the drugs used or their ingredients or to drugs with a similar chemical structure
- •17.Simultaneous participation in another interventional clinical trial (including within the last 4 weeks before inclusion)
- •18.Addictions or other illnesses that do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences
- •19.Pregnant or breastfeeding women
- •20.Women of childbearing potential, except women who meet the following criteria:
- •a.post-menopausal (12 months natural amenorrhoea or 6 months amenorrhoea with serum FSH > 40 U/ml)
- •b.postoperative (6 weeks after bilateral ovarectomy with or without hysterectomy)
- •c.regular and correct use of a contraceptive method with a Pearl Index < 1% per year, which will have to be continued for up to four months after the discontinuation of the study drug
- •d.sexual abstinence
- •e.Vasectomy of the partner
- •21.Male subjects who are able to father a child, except men who meet the following criteria:
- •a.willingness to abstain from heterosexual intercourse or use a protocol-recommended method contraception from the screening visit throughout the study treatment period and for four months following the last dose of study drug
- •b.refrain from sperm donation from screening visit throughout the study treatment period and for 90 days following the last dose of study drug.
- •22.Indications that the subject is unlikely to adhere to the protocol (e.g., lack of compliance)
研究者
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