EUCTR2014-000569-35-DE进行中（未招募）1 期
A prospective, open-label, multicentre phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by GA101 and ibrutinib (BIG) followed by ibrutinib and GA101 maintenance in CLL patients (CLL2-BIG protocol) - CLL2-BIG
niversity of Cologne0 个研究点目标入组 62 人开始时间: 2014年10月16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
- 62
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
入选标准
- •1.Have documented CLL requiring treatment according to iwCLL criteria
- •2.Creatinine clearance = 30 ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured after 24 h urine collection
- •3.Adequate liver function as indicated by a total bilirubin = 2 x, AST, and ALT = 2.5 x the institutional ULN value, unless directly attributable to the patient’s CLL or to Gilbert’s Syndrome
- •4.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 and HBV-DNA PCR is performed every month until 3 months after last dosage of GA101), negative testing for hepatitis-C RNA and negative HIV test within 6 weeks prior to registration
- •5.Age at least 18 years
- •6.ECOG 0 – 2; ECOG 3 is only permitted if related to CLL (e.g. due to anaemia or severe constitutional symptoms)
- •7.Life expectancy = 6 months
- •8.Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
- •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 62
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 62
排除标准
- •1.Transformation of CLL (i.e. Richter’s transformation, prolymphocytic leukaemia)
- •2.Known central nervous system (CNS) involvement
- •3.Patients with a history of confirmed PML
- •4.Malignancies other than CLL currently requiring systemic therapies
- •5.Use of investigational agents which would interfere with the study drug within 28 days prior to registration
- •6.Active infection requiring systemic treatment
- •7.Any comorbidity or organ system impairment rated with a CIRS (cumulative illness rating scale) score of 4, excluding the eyes/ears/nose/throat/larynx organ system or any other life-threatening illness, medical condition or organ system dysfunction that – in the investigator´s opinion could comprise the patients safety or interfere with the absorption or metabolism of the study drugs
- •8.Known hypersensitivity to GA101 (obinutuzumab), ibrutinib or any of the excipients
- •9.Requirement of treatment with strong CYP3A4-inhibitors/-inducers or anticoagulant with warfarin or phenoprocoumon (marcumar)
- •10.History of stroke or intracranial haemorrhage within 6 months prior to randomization
- •11.Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of treatment)
- •12.Fertile men or women of childbearing potential unless:
- •a. surgically sterile or = 2 years after the onset of menopause
- •b.willing to use two methods of reliable contraception including one highly effective (Pearl Index <1) and one additional effective (barrier) method during study treatment and for 12 months after end of study treatment.
- •13.Vaccination with a live vaccine a minimum of 28 days prior to randomization
- •14.Legal incapacity
- •15.Prisoners or subjects who are institutionalized by regulatory or court order
- •16.Persons who are in dependence to the sponsor or an investigator
研究者
相似试验
进行中（未招募）
1 期
A prospective, open-label, multicentre phase-II trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by ofatumumab and ibrutinib followed by ibrutinib and ofatumumab maintenance in CLL patients (CLL2-BIO-trial of the GCLLSG)Fit and unfit patients with previously untreated or relapsed/refractory CLL requiring treatmentMedDRA version: 20.0Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2014-000590-39-DEniversity of Cologne62
进行中（未招募）
1 期
A prospective, open-label, multicentre phase-II-trial to evaluate the efficacy and safety of a sequential regimen of Bendamustine followed by GA101 (Obinutuzumab) and ABT-199 (Venetoclax) followed by ABT-199 and GA101 maintenance in CLL patientsEUCTR2014-000580-40-DEniversity of Cologne62
进行中（未招募）
1 期
Evaluation of a treatment with bendamustine, followed by obinutuzumab, acalabrutinib and venetoclax in patients with relapsed chronic lymphocytic leukemiaPatients with relapsed/refractory CLL requiring treatmentMedDRA version: 21.1Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-003133-28-DEniversität zu Köln46
已完成
2 期
A prospective, open-label, multicenter phase-II trial to evatuate the efficacy and safety of a sequential regimen of bendamustine followed by GA101 and ibrutinib followed by ibrutinib and GA101 maintenance in CLL patientsC91.1Chronic lymphocytic leukaemia of B-cell typeDRKS00007710niversität zu Köln66
进行中（未招募）
1 期
Evaluation of a treatment with bendamustine, followed by obinutuzumab,zanubrutinib and venetoclax in patients with relapsed chronic lymphocyticleukemiaPatients with relapsed/refractory CLL requiring treatmentMedDRA version: 21.1Level: PTClassification code 10008958Term: Chronic lymphocytic leukaemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-003270-27-DEniversität zu Köln B.1.240