Semaglutide in Auto-HSCT

Официальное название

Semaglutide Treatment for PRevention Of Toxicity in High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation

Обзор

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.

Вмешательства

• Препарат Semaglutide Pen Injector [Ozempic]
  Semaglutide active drug
• Препарат Placebo
  semaglutide placebo

Первичные конечные точки

• gastrointestinal mucositis severity [Срок оценки: from day of stem cell infusion (day 0) to week +3]

Вторичные конечные точки (4)

• CRP increment [Срок оценки: from day of stem cell infusion (day 0) to week +3]
• Quality of life general [Срок оценки: change from baseline (start of high-dose chemotherapy) to study week 9 and 18]
• Quality of life - high-dose chemotherapy treatment specific [Срок оценки: change from baseline (start of high-dose chemotherapy) to study week 9 and 18]
• Safety profile evaluated by number of SARs [Срок оценки: Start of study drug treatment (week 1) until study week 10]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Diabetes
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Sorum ME, Gang AO, Tholstrup DM, Gudbrandsdottir S, Kissow H, Kornblit B, Muller K, Knop FK. Semaglutide treatment for PRevention Of Toxicity in high-dosE Chemotherapy with autologous haematopoietic stem-cell Transplantation (PROTECT): study protocol for a randomised, double-blind, placebo-controlled, investigator-initiated study. BMJ Open. 2024 Oct 9;14(10):e089862. doi: 10.1136/bmjopen-2024-0898 PMID 39384243

Идентификаторы

NCT: NCT06449625 · U1111-1277-7868 · 2022-502139-20-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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