Semaglutide Treatment for Prevention of Toxicity in High-dose Chemotherapy with Autologous Hematopoietic Stem Cell Transplantatio

Phase 1

Conditions: Mucositis and systemical inflammation, which is a treatment-related complication after treatment with high-dose chemotherapy
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: CTIS2022-502139-20-00

Lead Sponsor: Rigshospitalet

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Referral for auto-HSCT for relapsed diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma, Age = 18 years, BMI = 18.5, ECOG performance status = 2, Literate in Danish and/or English

Exclusion Criteria

Diabetes, Pregnant or nursing females, Previous or current gastrointestinal malignancy, Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2. 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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).;Secondary Objective: To evaluate the effect and safety of semaglutide in reducing gut barrier injury and systemic inflammation in patients undergoing auto-HSCT.;Primary end point(s): GI mucositis severity: mean severity grade (0-II) from study week 5 to 9

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):CRP increment in the early post-transplant phase: area under the plasma concentration-time curve (AUC) from study week 5 to 8;Secondary end point(s):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;Secondary end point(s):Safety profile: evaluated by SAR according to ICH-GCP guidelines