EUCTR2014-000582-47-DE进行中（未招募）1 期
A prospective, open-label, multicenter phase-II-trial to evaluate the efficacy and safety of a sequential regimen of bendamustine followed by GA101 (obinutuzumab) and CAL-101 (idelalisib) followed by CAL-101 and GA101 maintenance in CLL patients (CLL2-BCG-trial of the GCLLSG) - CLL2-BCG
niversity of Cologne0 个研究点目标入组 62 人开始时间: 2015年2月9日最近更新:
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. relapsed/refractory CLL requiring treatment according to iwCLL criteria with at least one of the following features:
- •-del(17p)/TP53 mutation
- •-ineligibility for ibrutinib due to refractoriness, intolerance or contraindications to receive ibrutinib (e.g. intake of vitamin k antagonists)
- •Patients must have recovered from acute toxicities of the previous treatment and pre-treatment must be stopped within the following time periods before start of the study treatment in the CLL2-BCG trial:
- •- chemotherapy within = 28 days
- •- antibody treatment within = 14 days
- •- kinase inhibitors, Bcl-2-antagonists or immunmodulatory agents within = 3 days
- •- corticosteroids may be applied until the start of the BCG-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 10 9/L, a neutrophil count = 1,0 x 10 9/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 = 1.5x, 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 month until 1 year after last dosage of GA101), 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 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, pro-lymphocytic leukemia)
- •2. Known central nervous system (CNS) involvement
- •3. Patients with confirmed PML
- •4. Malignancies other than CLL currently requiring systemic therapy
- •5. Active 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 life-threatening 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. Ongoing inflammatory bowel disease
- •8. Ongoing drug induced pneumonitis
- •9. Use of investigational agents which would interfere with the study drug within 28 days prior to registration
- •10. Known hypersensitivity to GA101 (obinutuzumab), CAL-101 (idelalisib) 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
- •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 (3-monthly))
- •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 18 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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