2025-523921-17-00招募中2 期
Interleukin-1 inhibition to improve the response of myeloproliferative neoplasms resistant to cytoreductive treatment
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Baseline and 3-month serum calprotectin levels.
研究概览
简要总结
To demonstrate a decrease in serum calprotectin levels at 3 months in the anakinra arm compared with the standard of care.
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
- 否
入选标准
- •Diagnosis of MPN: PV, ET, or PMF according to WHO criteria
- •Stable cytoreductive therapy for at least 6 months
- •Incomplete hematologic response according to ELN criteria, excluding bone marrow, OR complete hematologic response with anemia in ET, OR persistence of general clinical symptoms (fever, night sweats, pruritus, fatigue > 5/10 on VAS)
- •Adult patient capable of providing informed consent
排除标准
- •Recurrent or poorly controlled infections
- •Lack of understanding of questionnaires or inability to follow up.
- •Women of childbearing potential unwilling to use appropriate contraception.
- •Thrombocytopenia < 100 G/L
- •Neutropenia < 1 G/L
- •Hypersensitivity to the active substance, any excipients, or proteins derived from Escherichia coli
- •Concomitant immunosuppressive therapy
- •Refusal to participate
- •Patient under legal protection (guardianship, curatorship, etc.)
- •Patients unable to consent.
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe.
Test
干预措施: Kineret 100 mg/0.67 ml solution for injection in pre-filled syringe. (Drug)
结局指标
主要结局
Baseline and 3-month serum calprotectin levels.
Baseline and 3-month serum calprotectin levels.
次要结局
- - Multiplex assay of inflammatory cytokines at baseline, 3 and 6 months
- - Improvement (yes/no) of the response statusresponse status (according to ELN criteria) between baseline-M3, baseline-M6, M3-M6
- - hematological parameters (e.g., hemoglobin, hematocrit, white blood cell count, platelet count) at baseline, 3 and 6 months..
- - Patient-reported symptom severity over the previous 4 weeks assessed using a 10-point Visual Analog Scale (VAS) for pruritus, fever, and night sweats at baseline, 3 and 6 months.
- - Treatment-related adverse events (type and number)
- - Daily self-reported treatment intake (Yes/No) recorded in the patient diary over the 3-month period
- - EORTC QLQ-C30 score at baseline, 3 and 6 months
- - Quantification of JAK2V617F, CALR exon 9, or MPL W515 at baseline, 3 and 6 months
- - Measurement of circulating CD34+ cells at baseline, 3 and 6 months
研究者
DOLOU Julien
Scientific
Centre Hospitalier Regional Et Universitaire De Brest
研究点 (5)
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