2023-504724-25-00招募中3 期
A Phase 3, Randomized, Double-blind, Add-on Study Evaluating the Safety and Efficacy of Navtemadlin Plus Ruxolitinib vs Placebo Plus Ruxolitinib in Patients with Myelofibrosis Who Have a Suboptimal Response to Ruxolitinib
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 118
- 试验地点
- 122
- 主要终点
- SVR will be evaluated 24 weeks after randomized treatment begins by MRI/CT scan (central review).
研究概览
简要总结
Co-primary objectives:
To compare spleen volume reduction (SVR) between Arm 1 and Arm 2 To compare total symptom score (TSS) reduction between Arm 1 and Arm 2
研究设计
- 分配方式
- Randomized
- 主要目的
- Long-term follow-up
- 盲法
- Double (Subject, Investigator, Analyst, Monitor)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Ruxolitinib Run-In Period:
- •Adults ≥ 18 years of age able to provide informed consent.
- •Ruxolitinib Run-In Period:
- •Confirmed diagnosis of PMF, post-PV MF, or post-ET MF, as assessed by the treating physician according to the World Health Organization (WHO) criteria
- •Ruxolitinib Run-In Period:
- •High, Intermediate-1, Intermediate-2 risk category International Prognosis System Score (IPSS)
- •Ruxolitinib Run-In Period:
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Ruxolitinib Run-In Period:
- •JAK-inhibitor treatment naive
- •Randomized Add-on Period:
- •PMF, post-PV MF, or post-ET MF that is TP53WT as assessed by central testing.
- •Randomized Add-on Period:
- •ECOG performance status of 0 to
- •Randomized Add-on Period:
- •Treatment with a stable dose of ruxolitinib
- •Randomized Add-on Period:
- •Suboptimal response to run-in ruxolitinib therapy
排除标准
- •Ruxolitinib Run-In Period:
- •Prior Splenectomy
- •Ruxolitinib Run-In Period:
- •Splenic irradiation within 3 months prior to the first dose
- •Ruxolitinib Run-In Period:
- •Prior BCL-XL, BET, MDM2, PI3K, PIM, or XPO1 inhibitors therapy or p53- directed therapy
- •Ruxolitinib Run-In Period:
- •Eligible for Bone Marrow Transplant
- •Ruxolitinib Run-In Period:
- •Peripheral blood or bone marrow blast count ≥ 10%
- •Randomized Period:
- •Peripheral blood or bone marrow blast count ≥ 10%
结局指标
主要结局
SVR will be evaluated 24 weeks after randomized treatment begins by MRI/CT scan (central review).
SVR will be evaluated 24 weeks after randomized treatment begins by MRI/CT scan (central review).
TSS reduction will be evaluated 24 weeks after randomized treatment begins using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
TSS reduction will be evaluated 24 weeks after randomized treatment begins using the Myelofibrosis Symptom Assessment Form (MFSAF) v4.0.
次要结局
- The proportion of patients who have spleen volume reduction between Arm 1 and Arm 2
- The proportion of patients who have TSS reduction between Arm 1 and Arm 2
- Time to death from any cause in patients randomized to each arm
- Time to progression or death from any cause in patients randomized to each arm
- Analyses of the safety endpoints will include the following measurements or assessments: physical examinations, laboratory tests, adverse events (AEs), serious AEs (SAEs), electrocardiograms (ECGs), and vital signs
- Change in SVR 24 weeks after the randomized treatment begins
- Change in TSS 24 weeks after the randomized treatment begins
研究者
Clinical Operations Lead
Scientific
Kartos Therapeutics Inc.
研究点 (122)
Loading locations...
相似试验
已完成
4 期
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
招募中
2 期
Perioperative Cadonilimab Combined With Neoadjuvant Chemotherapy in Resectable Esophageal Squamous Cell Carcinoma (ESCC)NCT07263919Akeso90
招募中
不适用
Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast CancerNCT07285382wanghaibo120
进行中（未招募）
2 期
Taldefgrobep Alfa in Adults With Overweight and ObesityObesityNCT07281495Biohaven Therapeutics Ltd.150
招募中
2 期
Vorasidenib Study in Pediatric Participants With Grade 2 Astrocytoma or Oligodendroglioma With an IDH1 or IDH2 MutationNCT07286292Institut de Recherches Internationales Servier (I.R.I.S.)10