EUCTR2020-000097-15-GR进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study of Navitoclax in Combination with Ruxolitinib Versus Ruxolitinib in Subjects with Myelofibrosis - TRANSFORM-1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 230
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
- •Subject = 18 years of age.
- •Subject with a documented diagnosis of primary myelofibrosis (MF) or secondary MF (post polycythemia vera [PPV] -MF or post essential thrombocythemia [PET] – MF) as defined by the World Health Organization classification.
- •Subject must be able to complete the Myelofibrosis Symptom Assessment Form (MFSAF) on at least 4 out of 7 days prior to randomisation.
- •- Subject classified as intermediate-2 or high-risk MF as defined by the Dynamic International Prognostic Scoring System Plus (DIPSS+).
- •Subject has splenomegaly defined as spleen palpation measurement = 5 cm below costal margin or spleen volume = 450 cm^3 as assessed centrally by MRI or CT scan.
- •Subject has at least 2 symptoms measurable (score = 3) or a total score of = 12, as measured by the MFSAF v4.0.
- •Subject with an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- •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 92
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 138
排除标准
- •Subject must not have received prior treatment with a JAK-2 inhibitor.
- •Subject must not have received prior treatment with a BH3-mimetic compound or bromodomain and extra-terminal motif (BET) inhibitor.
- •Subject must not be eligible for stem cell transplantation at time of study entry due to age, comorbidities, or unfit for unrelated or unmatched donor transplant.
- •Subject must not receive medication that interferes with coagulation or platelet function within 3 days prior to the first dose of study drug or during the study treatment period.
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