NCT07424950尚未招募2 期
Phase 2 Study to Assess the Safety and Efficacy of Bomedemstat (IMG-7289) in Combination With Momelotinib in Patients With Myelofibrosis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- SVR35 at Week 24
研究概览
简要总结
This is an open-label, single-arm, Phase 2 interventional study designed to evaluate the safety and efficacy of Bomedemstat (IMG-7289) when added to Momelotinib in patients with Myelofibrosis (MF) who exhibit a suboptimal response to Momelotinib alone or who present with baseline cytopenias and do not achieve adequate improvement after 12 weeks of Momelotinib monotherapy.
The study consists of three phases:
- Screening Phase (up to 28 days)
- Momelotinib Monotherapy Phase - Weeks 0-12
- Combination Treatment Phase (Momelotinib + Bomedemstat) - Weeks 12-24
- Post-Treatment Follow-up Phase (30 days post last dose + long-term survival follow-up) All patients will continue on Momelotinib throughout the study unless toxicity or safety considerations necessitate modification.
详细描述
Myelofibrosis is a disease with heterogeneous driver pathways involving JAK-STAT activation, inflammatory cytokine signaling, and aberrant megakaryopoiesis. Momelotinib targets JAK1/JAK2 and ACVR1, improving anemia and splenomegaly. However, a proportion of patients fail to achieve adequate spleen, symptom, or hematologic improvement.
Bomedemstat, an irreversible LSD1 inhibitor, may:
- Modify megakaryocyte function
- Reduce fibrosis
- Improve cytokine dysregulation
- Impact stem/progenitor dynamics Sequential introduction of Bomedemstat at Week 12 allows assessment of Momelotinib's initial stabilizing effect and evaluates whether LSD1 inhibition can rescue suboptimal responders without compromising hematologic tolerability.
STUDY DURATION
- Screening: Up to 28 days
- Momelotinib monotherapy: Weeks 0-12
- Bomedemstat + Momelotinib combination: Weeks 12-24
- Primary endpoint assessment: Week 24
- Safety follow-up: 30 days post last dose
- Long-term follow-up: Every 12 weeks for up to 12 months Total participation duration per patient: Approximately 14-16 months
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Masking Description
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Male or female participants ≥18 years of age on the day of signing informed consent.
- •2. Histologically confirmed diagnosis of:
- •Primary Myelofibrosis (PMF), or
- •Secondary MF following Polycythaemia Vera (post-PV MF), or
- •Secondary MF following Essential Thrombocythaemia (post-ET MF) (as defined by WHO 2022 criteria)
- •Disease risk category:
- •Intermediate-2 or High-risk MF according to DIPSS.
- •Cohort assignment (Investigator-defined; permitted insertion):
- •Cohort 1 - Momelotinib-Experienced:
- •Receiving Momelotinib 200 mg QD for ≥12 weeks prior to Week 12 assessment
- •Demonstrates suboptimal response at Week 12 (definition below)
- •Cohort 2 - Cytopenic MF:
- •Baseline Hb <10 g/dL and/or platelets <100 × 10⁹/L
- •Starting Momelotinib at Week 0
- •Demonstrates suboptimal response at Week 12
排除标准
- •5.2.1 Medical Conditions
- •Known hypersensitivity to Bomedemstat or MAOIs
- •Clinically significant GI conditions affecting absorption
- •Increased bleeding risk
- •Hereditary bleeding disorders
- •Active or chronic bleeding within 8 weeks
- •Autoimmune bleeding disorders
- •Uncontrolled comorbidities
- •Active secondary malignancies (with exceptions)
- •HBV/HCV/HIV status not meeting template criteria
- •Receipt of prohibited medications within 14 days (All text unchanged.)
- •5.2.2 Prohibited Prior Therapies
- •Prior treatment with Bomedemstat or other LSD1 inhibitors
- •MAOIs or strong CYP3A4 modifiers
- •All hematopoietic growth factors (G-CSF, GM-CSF, EPO, TPO mimetics)
- •Investigational treatments within 4 weeks
- •Investigator addition permitted:
- •Prior treatment with Momelotinib is allowed for Cohort 1 (required)
- •Prior treatment with Momelotinib is allowed for Cohort 2 (not required)
- •Prior exposure to other JAK inhibitors (e.g., ruxolitinib, fedratinib) is allowed unless associated with severe toxicity
- •5.2.3 Prohibited During Study (Verbatim text from first file retained)
- •Strong inhibitors/inducers of CYP3A4
- •Anticoagulants/antiplatelets/NSAIDs when platelets <100 ×10⁹/L
研究组 & 干预措施
Bomedemstat + Momelotinib
Experimental
Bomedemstat + Momelotinib
干预措施: bomedemstat (Drug)
结局指标
主要结局
SVR35 at Week 24
时间窗: 24 weeks
spleen value reduction by 35%
次要结局
未报告次要终点
研究者
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