EUCTR2015-004606-41-DE进行中（未招募）1 期
A PROSPECTIVE, OPEN-LABEL, MULTICENTRE PHASE-II TRIAL OF IBRUTINIB PLUS VENETOCLAX PLUS OBINUTUZUMAB IN PHYSICALLY FIT (CIRS = 6 & NORMAL CREATININE CLEARANCE) OR UNFIT (CIRS >6 OR CREATININE CLEARANCE > 50 ML/MIN) PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH TP53 DELETION (17P-) AND/OR MUTATION (CLL2-GIVE-TRIAL OF THE GCLLSG) - CLL2-GIVe
niversity Hospital Ulm0 个研究点目标入组 40 人开始时间: 2016年4月21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
- 40
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.Have documented CLL according to iwCLL criteria and measurable disease (lymphocytosis > 5x109 with/without measurable lymph nodes and/or organomegaly) assessed by physical exam and/or CT
- •2.Subjects must have untreated CLL, i.e. no prior chemotherapy, antibody therapy or non-chemotherapeutic agent (BTK, PI3K, BCL2 inhibitor or similar). Local irradiation or short term (up to 1 month) corticosteroid treatment for autoimmune phenomena are allowed
- •3.Subjects must have TP53 deletion (17p-) and/or mutation (in bone marrow or peripheral blood), with pre-existing local test results confirmed by central laboratory in Ulm
- •4.CLL requiring treatment (active disease”) according to the iwCLL criteria
- •5.ECOG = 2
- •6.Creatinine clearance = 50 ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured after 24 h urine collection
- •7.Adequate liver function as indicated by a total bilirubin = 2 x, AST, and ALT = 3 x the institutional ULN value, unless directly attributable to the patient’s CLL or to Gilbert’s Syndome
- •8.No cardiovascular disability of New York Heart Association (NYHA) Class > 2. Class 2 is defined as comfortabilty at rest but moderate physical activity causes dyspnoea, angina pain or fatigue
- •9.Adequate bone marrow function (unless directly attributable to CLL, BM examination required):
- •ANC = 1000/µl or
- •ANC < 1000/µl, if attributable to the underlying CLL (growth factor support may be administered after screening)
- •Platelets > 30.000/µl (unless directly attributable to the
- •underlying CLL)
- •10 Hemoglobin = 8g/dl (unless directly attributable to the
- •underlying CLL)
- •11.Negative serological testing for hepatitis B (i.e. HBsAg negative and anti-HBc negative, patients positive for anti-HBc may be included if PCR for HBV DNA is negative) negative testing for hepatitis-C RNA and negative HIV test within 6 weeks prior to registration.
- •[Patients who are HBsAg negative/anti-HBc positive with undetectable serum HBV DNA should be monitored closely (every month) for HBV DNA by a real-time PCR quantification assay with a lower limit of detection of the order of 10 WHO IU/mL until at least 24 months after the last treatment cycle with obinutuzumab. If the HBV DNA assay becomes positive, patients should pre-emptively be treated with a nucleoside analogue (i.e. lamivudine) for at least 24 months after the last cycle of therapy with obinutuzumab or be referred to a gastroenterologist for management.]
- •12.Age at least 18 years
- •13.Life expectancy = 6 months
- •14.Must be able to adhere to the study visit schedule and other protocol requirements
- •15.Able and willing to provide written informed consent and to comply with the study protocol procedures
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •1.Transformation of CLL (i.e. Richter’s transformation, prolymphocyctic leukemia)
- •2.One or more individual organ / system impairment score of 4 as assessed by the CIRS definition, excluding the Eyes, Ears, Nose, Throat and Larynx organ system
- •3.Known central nervous system (CNS) involvement
- •4.Patients with a history of PML
- •5. Impairment of plasmatic coagulation as indicated by Quick = 60% and / or PTT = 50 sec. unless explicabledue to by iatrogenic measure
- •6.Active malignancies other than CLL within the past 2 years prior to study entry, with the exception:
- •Adequately treated in situ carcinoma of the cervix uteri
- •Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin
- •Previous malignancy confined and surgically resected (or treated with other modalities) with curative intent and in remission at time of screening
- •7.Use of agents which would interfere with the study drug within 28 days prior to registration
- •8.Uncontrolled infection requiring systemic treatment
- •9.History of severe infusion-related reaction to humanized or murine monoclonal antibodies, and/ or known sensitivity or allergy to murine products or allergy to xanthin oxidase and rasburicase or glucose-6-phosphate dehydrogenase deficiency
- •10.Requires treatment with the following drugs:
- •Within 7 days prior to the first dose of study drug: No steroid therapy higher than 20 mg Prednisolone for anti-neoplastic intent; No CYP3A inhibitors (e.g. fluconazole, ketoconazole, clarithromycin); No potent CYP3A inducers (e.g., rifampin, phenytoin or carbamazepine);
- •Within 3 days prior to the first dose of study drug: Grapefruit or grapefruit products; Seville oranges (including marmalade); Star fruit.
- •11.History of stroke or intracranial hemorrhage within 6 months prior to registration
- •12.Pregnant women and nursing mothers
- •13.Fertile men or women of childbearing potential unless:
- •a.surgically sterile or = 2 years after the onset of menopause
- •b.willing to use two highly effective contraceptive methods (Pearl Index <1) during study treatment and for 18 months after end of study treatment.
- •14.Vaccination with a live vaccine a minimum of 28 days prior to registration
- •15.Legal incapacity
- •16.Prisoners or subjects who are institutionalized by regulatory or court order
- •17.Persons who are in dependence to the sponsor or an investigator
研究者
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