2023-507276-53-00已完成2 期
A Phase 2 Open-Label Study Evaluating Tolerability and Efficacy of Navitoclax Alone or in Combination with Ruxolitinib in Subjects with Myelofibrosis (REFINE)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 16
- 主要终点
- ≥ 35% spleen volume reduction from baseline (SVR35) at Week 24 measured by MRI/CT.
研究概览
简要总结
Evaluate the effect of navitoclax alone or in combination with ruxolitinib on spleen volume
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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.
结局指标
主要结局
≥ 35% spleen volume reduction from baseline (SVR35) at Week 24 measured by MRI/CT.
≥ 35% spleen volume reduction from baseline (SVR35) at Week 24 measured by MRI/CT.
次要结局
- The secondary endpoints are at least 50% reduction in total symptom score from baseline measured by MFSAF 4.0; anemia response; and change in grade of bone marrow fibrosis.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (16)
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