Semaglutide Treatment for PRevention Of Toxicity in High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 主要终点
- gastrointestinal mucositis severity
研究概览
简要总结
The primary objective of this clinical trial is to ievaluate the effect of semaglutide (GLP-1 receptor agonist) in reducing intensity of gastrointestinal (GI) mucositis in patients undergoing high-dosage chemotherapy followed by autologous (auto) haematopoietic stem cell transplantation (HSCT). The secondary objective is to evaluate the effect and safety of semaglutide in reducing gut barrier injury and systemic inflammation in patients undergoing auto-HSCT.
Study design:
The study is designed as a randomized, double-blind, placebo-controlled, phase 2, two-centre investigator-initiated clinical study.
Patients referred for treatment with high-dose chemotherapy and auto-HSCT will be randomized in a 1:1 manner to receive either semaglutide or placebo. The study includes a run-in period 3 to 4-week low-dose period with semaglutide subcutaneously (s.c.) 0.25 mg once-weekly (QW) prior to high-dose chemotherapy treatment followed by a period of 4 to 5 weeks with semaglutide 0.5 mg QW. Total duration of treatment with investigational drug will be 8 weeks. Total study duration for the individual patients will be 20-22 weeks, including a 2-4-week screening period and 10 weeks of follow-up.
Study population:
A planned total number of 40 patients will be randomized.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referral for auto-HSCT for relapsed diffuse large B-cell lymphoma or follicular lymphoma
- •Age ≥ 18 years
- •BMI ≥ 18.5
- •ECOG performance status* ≤ 2
- •Literate in Danish and/or English
排除标准
- •Inflammatory bowel disease
- •Previous or current gastrointestinal malignancy
- •Personal or family history of medullary thyroid carcinoma or MEN syndrome
- •Genetic disorders with defective tissue repair (e.g., Fanconi anaemia)
- •History of pancreatitis (acute or chronic)
- •Renal impairment measured as eGFR value of < 30 ml/min/1.73 m2
- •Impaired liver function, defined as alanine aminotransferase ≥ 2.5 times upper normal limit at screening
- •Known or suspected hypersensitivity to semaglutide or other GLP-1RA
- •Pregnant or nursing females
研究组 & 干预措施
Semaglutide
Semaglutide active drug 0.25-0.5mg, once-weekly, injection
干预措施: Semaglutide Pen Injector [Ozempic] (Drug)
Placebo
Semaglutide placebo, once-weekly, injection
干预措施: Placebo (Drug)
结局指标
主要结局
gastrointestinal mucositis severity
时间窗: from day of stem cell infusion (day 0) to week +3
mean severity grade (0-II)
次要结局
- CRP increment(from day of stem cell infusion (day 0) to week +3)
- Quality of life general(change from baseline (start of high-dose chemotherapy) to study week 9 and 18)
- Safety profile evaluated by number of SARs(Start of study drug treatment (week 1) until study week 10)
- Quality of life - high-dose chemotherapy treatment specific(change from baseline (start of high-dose chemotherapy) to study week 9 and 18)
研究者
Klaus Gottlob Müller
Professor, consultant
Rigshospitalet, Denmark