EUCTR2016-004707-32-IT进行中（未招募）1 期
A Multi-Center, Open Label, Uncontrolled, Phase 2a Clinical Trial Evaluating the Safety and Efficacy of the Addition of Ibrutinib to Venetoclax through a MRD-guided Approach in Relapsed/Refractory Patients with Chronic Lymphocytic Leukemia (CLL) - IMPROVE (PS-CLL-002)
OSPEDALE SAN RAFFAELE0 个研究点目标入组 31 人开始时间: 2021年6月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 31
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 according to the IWCLL criteria (Hallek et al. 2008)
- •2.Relapsed/refractory CLL patients who received at least 1 prior therapy
- •3.Adequate bone marrow function without transfusion < 2 weeks of screening as follows:
- •a.Absolute neutrophil count (ANC) =1.0 x 109/L (growth factors administration is allowed)
- •b.Platelets =30 x 109/L. If thrombocytopenia due to BM involvement, platelets should be = 20 x 109/L
- •c.Hemoglobin value =8.0 g/dl
- •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 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1.Transformation of CLL to aggressive NHL (Richter’s transformation or pro-lymphocytic leukemia)
- •2.Known central nervous system (CNS) involvement
- •3.Inadequate renal function: CrCl <30 mL/min
- •4.Previous treatment with BTK and/or BCL2 inhibitors (patients previously treated with PI3K inhibitors are eligible)
- •5.Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia
- •6.Requires the use of warfarin, marcumar, or phenprocoumon (potential drug-drug interaction increasing exposure of warfarin or phenprocoumon): low molecular weight drugs e.g. heparin are acceptable
- •7.Treatment, administration or consumption of any of the following within 3 days prior to the first dose of venetoclax (see also Appendix G).
- •a.Strong Cytochrome P450 3A (CYP3A) inhibitors
- •b.Moderate CYP3A inhibitors
- •c.Moderate or strong CYP3A inducers
- •d.PI3K inhibitors (e.g. Idelalisib);
- •e.Grapefruit or grapefruit products
- •f.Seville oranges (including marmalade containing Seville oranges)
- •g.Star fruit
- •8. Known history of human immunodeficiency virus (HIV) or active with hepatitis B virus (HBV) or hepatitis C virus (HCV). Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
- •9.History of other malignancies, except:
- •a.Malignancy treated with curative intent and with no known active disease present for =3 years before the first dose of study drug and felt to be at low risk for recurrence by treating physician.
- •b.Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- •c.Adequately treated carcinoma in situ without current evidence of disease.
研究者
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