CTIS2023-507276-53-00进行中（未招募）1 期
A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis (REFINE) - M16-109
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 191
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
- •Subjects = 18 years of age, Cohorts 1b and 3 only: Subject has at least 2 symptoms each with a score = 3 or a total score of = 12, as measured by the MFSAF v4.0 on at least 4 out of 7 days during screening prior to study drug dosing, Subject has splenomegaly defined as spleen palpation measurement = 5 cm below costal margin or spleen volume = 450 cm3 as assessed by MRI/CT, Subject must meet the laboratory parameters (adequate bone marrow, renal and hepatic function) as defined in the protocol., Subjects with documented diagnosis of Intermediate or High-risk Primary myelofibrosis, post-polycythemia vera myelofibrosis or postessential thrombocythemia myelofibrosis, Subjects classified as intermediate-2 or high-risk myelofibrosis, as defined by the Dynamic International Prognostic Scoring System (DIPSS), Subject must be ineligible due to age, comorbidities, or unfit for unrelated or unmatched donor transplantation or unwilling to undergo stem cell transplantation at time of study entry, ECOG 0, 1, or 2, Cohort 1a only: Subject must have received ruxolitinib therapy for at least 12 weeks and be currently on a stable dose of = 10 mg twice daily of ruxolitinib for = 8 weeks prior to the 1st dose of navitoclax., Cohort 1b only: Subject must have received treatment with ruxolitinib for = 24 weeks with lack of efficacy OR for < 24 weeks with documented disease progression while on ruxolitinib OR for = 28 days with intolerance defined as new RBC transfusion requirement, Cohort 2 only: Subject must have received prior treatment with JAK-2 inhibitor therapy for at least 12 weeks OR for = 28 days complicated by development of red blood cell transfusion requirement (at least 2 units/month for 2 months) OR grade = 3 adverse events of thrombocytopenia, anemia, hematoma and/or hemorrhage, Cohort 3 only: Subject must not have received prior treatment with a JAK-2 or BET inhibitor
排除标准
- •Splenic irradiation within 6 months prior to screening, or prior splenectomy., Leukemic transformation (> 10% blasts in peripheral blood or bone marrow aspirate/biopsy)., Prior therapy with a BH3 mimetic compound or stem cell transplantation.
研究者
相似试验
进行中（未招募）
1 期
A Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax alone or in Combination with Ruxolitinib in Subjects with MyelofibrosisMedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MyelofibrosisEUCTR2017-001398-17-ITABBVIE DEUTSCHLAND GMBH & CO. KG164
进行中（未招募）
1 期
An Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax alone or in Combination with Ruxolitinib in Subjects with MyelofibrosisMyelofibrosisEUCTR2017-001398-17-GBAbbVie Deutschland GmbH & Co. KG164
已完成
2 期
A Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis (REFINE)Myelofibrosis2023-507276-53-00AbbVie Deutschland GmbH & Co. KG58
进行中（未招募）
1 期
A Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis (REFINE)MedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MyelofibrosisEUCTR2017-001398-17-HRAbbVie Deutschland GmbH & Co. KG174
进行中（未招募）
1 期
A Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis (REFINE)MyelofibrosisMedDRA version: 20.0Level: PTClassification code 10028537Term: MyelofibrosisSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2017-001398-17-HUAbbVie Deutschland GmbH & Co. KG174