2022-502139-20-00招募中2 期
Semaglutide Treatment for Prevention of Toxicity in High-dose Chemotherapy with Autologous Hematopoietic Stem Cell Transplantation – a randomized, double-blind, placebo-controlled, investigator-initiated study
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- GI mucositis severity: mean severity grade (0-II) from study week 5 to 9
研究概览
简要总结
To evaluate the effect of semaglutide in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) hematopoietic stem cell transplantation (HSCT).
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
- •Referral for auto-HSCT for relapsed diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma
- •Age ≥ 18 years
- •ECOG performance status ≤ 2
- •Literate in Danish and/or English
排除标准
- •Pregnant or nursing females
- •Previous or current gastrointestinal malignancy
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type
- •Family is defined as a first degree relative
- •Genetic disorders with defective tissue repair (e.g. Fanconi anaemia)
- •History of pancreatitis (acute or chronic)
- •Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 30 ml/min/1.73 m2 as defined by KDIGO 2012 classification4
- •Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening
- •Known or suspected hypersensitivity to semaglutide or other GLP-1RA
- •Inflammatory bowel disease
结局指标
主要结局
GI mucositis severity: mean severity grade (0-II) from study week 5 to 9
GI mucositis severity: mean severity grade (0-II) from study week 5 to 9
次要结局
- CRP increment in the early post-transplant phase: area under the plasma concentration-time curve (AUC) from study week 5 to 8
- Quality of life (QOL): change from baseline (study week 4) to study week 9 and 18 evaluated by EORTC QLQ-C30 and EORTC QLQ-HDC29 questionnaires
- Safety profile: evaluated by SAR according to ICH-GCP guidelines
研究者
Klaus Müller
Scientific
Rigshospitalet
研究点 (2)
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