EUCTR2014-000590-39-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 ofatumumab and ibrutinib followed by ibrutinib and ofatumumab maintenance in CLL patients (CLL2-BIO-trial of the GCLLSG) - CLL2-BIO
niversity of Cologne0 个研究点目标入组 62 人开始时间: 2015年11月5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
- 性别
- All
入选标准
- •1. Documented CLL requiring treatment (irrespective if first- or relapse treatment) according to iwCLL criteria1
- •In case of previously treated patients, these must have recovered from acute toxicities and treatment regimen must be stopped within the following time periods before start of the study treatment in the CLL2-BIO trial:
- •- chemotherapy within = 28 days
- •- antibody treatment within = 14 days
- •- kinase inhibitors, Bcl-2-antagonists or immunomodulatory agents within = 3 days
- •- corticosteroids may be applied until the start of the BIO-regimen, these have to be reduced to an equivalent of = 20 mg prednisolone during treatment
- •2. Adequate hematologic function as indicated by a platelet count = 25 x 109/L, a neutrophil count = 1 ,0 x 1 09/L and a hemoglobin value = 8.0 g/dL, unless directly attributable to the patient´s CLL (e.g. bone marrow infiltration)
- •3. Adequate renal function as indicated by a creatinine clearance = 30ml/min calculated according to the modified formula of Cockcroft and Gault or directly measured with 24 hrs urine collection
- •4. Adequate liver function as indicated by a total bilirubin = 2x, AST/ALT = 2.5x the institutional ULN value, unless directly attributable to the patient’s CLL or to Gilbert’s Syndrome
- •5. Negative serological testing for hepatitis B (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 two months until 6 months after last dosage of ofatumumab), negative testing for hepatitis-C RNA and negative HIV antibody test within 6 weeks prior to registration
- •6. Age = 18 years
- •7. ECOG 0 to 2, ECOG 3 is only permitted if related to CLL (e.g. due to anemia or severe constitutional symptoms)
- •8. Life expectancy = 6 months
- •9. 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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 42
排除标准
- •1. Transformation of CLL (i.e. Richter’s transformation, prolymphocytic leukemia)
- •2. Known central nervous system (CNS) involvement
- •3. Patients with confirmed PML
- •4. Malignancies other than CLL currently requiring systemic therapy
- •5. Uncontrolled infection requiring systemic Treatment
- •6. 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 lifethreatening illness, medical condition or organ system dysfunction that – in the investigator´s opinion - could compromise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g, inability to swallow tablets or impaired resorption in the gastrointestinal tract)
- •7. Use of investigational agents which might interfere with the study drug within 3 days prior to registration
- •8. Known hypersensitivity to ofatumumab, ibrutinib or any of the excipients
- •Please note: Patients with a known hypersensitivity to bendamustine are allowed to participate but will not receive a debulking with bendamustine
- •9. Requirement of treatment with strong CYP3A4-inhibitors/-inducers or anticoagulant with phenoprocoumon (marcumar), warfarin, or other vitamin k antagonists
- •10. History of stroke or intracranial hemorrhage within 6 months prior to registration
- •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, on day one of every debulking and induction cycle (monthly) and on day one of every maintenance cycle (every three months))
- •12. Fertile men or women of childbearing potential unless:
- •- surgically sterile or = 2 years after the onset of menopause, or
- •- 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 = 28 days prior to registration
- •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
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