Semaglutide in Auto-HSCT

Launched by KLAUS GOTTLOB MÜLLER · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called semaglutide to see if it can help reduce digestive issues, known as gastrointestinal mucositis, in patients undergoing high-dose chemotherapy followed by a special treatment called autologous stem cell transplantation (auto-HSCT). The goal is to learn if semaglutide can help lessen the damage to the gut and lower inflammation during this challenging treatment process. The trial will involve 40 patients who are being treated for certain types of lymphoma and will be randomly assigned to receive either semaglutide or a placebo (a substance with no active medication) over an 8-week period.

To be eligible for this study, participants must be at least 18 years old, have a body mass index (BMI) of 18.5 or higher, and be able to read and understand Danish or English. However, people with diabetes, certain digestive diseases, or a history of specific cancers or other health issues won't be able to participate. If someone joins the study, they can expect to follow a structured treatment plan, including a few weeks of lower-dose semaglutide before receiving the higher dose, and will be monitored closely for about 20 to 22 weeks in total. The trial is not yet recruiting participants, so there will be more information available soon for those who are interested.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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