CTIS2024-514686-19-00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 (Ibrutinib treatment based on MRD-guided apPROach combined with VEnetoclax)
Ospedale San Raffaele S.r.l.0 个研究点目标入组 31 人开始时间: 2024年7月2日最近更新:
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
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Documented CLL requiring treatment according to the IWCLL criteria (Hallek et al. 2008), Relapsed/refractory CLL patients who received at least 1 prior therapy, 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
排除标准
- •Transformation of CLL to aggressive NHL (Richter’s transformation or pro-lymphocytic leukemia), Known central nervous system (CNS) involvement, Inadequate renal function: CrCl <30 mL/min, Previous treatment with BTK and/or BCL2 inhibitors (patients previously treated with PI3K inhibitors are eligible), Uncontrolled autoimmune hemolytic anemia or immune thrombocytopenia, 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, 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, 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., 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
相似试验
进行中（未招募）
1 期
Clinical trial with Ibrutinib and Venetoclax for patients with Relapsed/Refractory Chronic Lymphocytic LeukemiaRelapsed or Refractory Chronic Lymphocytic LeukemiaMedDRA version: 21.0Level: LLTClassification code 10008957Term: Chronic lymphatic leukemiaSystem Organ Class: 100000004864EUCTR2016-004707-32-ITOSPEDALE SAN RAFFAELE31
进行中（未招募）
1 期
A Clinical Trial Evaluating the Safety and Efficacy of Venetoclax in Combination with Atezolizumab and Obinutuzumab in Richter Transformation of Cronic Lymphocitic LeukemiaRichter syndrome of chronic lymphocytic leukemiaMedDRA version: 20.0Level: PTClassification code 10058728Term: Richter's syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-005028-40-ITAZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA28
进行中（未招募）
不适用
A clinical trial of NOX-A12 in patients with mutiple myeloma who have previously been treated and who will be receiving bortezomib and dexamethasone treatment.EUCTR2011-004651-40-ATOXXON Pharma AG28
进行中（未招募）
不适用
A clinical trial of NOX-A12 in patients with multiple myeloma who have previously been treated and who will be receiving bortezomib and dexamethasone treatmentRelapsed multiple myelomaMedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004651-40-ITOXXON PHARMA AG28
进行中（未招募）
不适用
A clinical trial of NOX-A12 in patients with mutiple myeloma who have previously been treated and who will be receiving bortezomib and dexamethasone treatment.Relapsed multiple myelomaMedDRA version: 14.1Level: PTClassification code 10028228Term: Multiple myelomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-004651-40-DEOXXON Pharma AG28