Semaglutide in Auto-HSCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide Pen Injector [Ozempic], Placebo.
- Who it may be relevant to
- Registry conditions: Intestinal Mucositis, Inflammation, Chemotherapeutic Toxicity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Semaglutide Treatment for PRevention Of Toxicity in High-dose Chemotherapy With Autologous Haematopoietic Stem Cell Transplantation
Overview
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.
Interventions
- Drug Semaglutide Pen Injector [Ozempic]
Semaglutide active drug - Drug Placebo
semaglutide placebo
Primary outcome measures
- gastrointestinal mucositis severity [Time frame: from day of stem cell infusion (day 0) to week +3]
Secondary outcome measures (4)
- CRP increment [Time frame: from day of stem cell infusion (day 0) to week +3]
- Quality of life general [Time frame: change from baseline (start of high-dose chemotherapy) to study week 9 and 18]
- Quality of life - high-dose chemotherapy treatment specific [Time frame: change from baseline (start of high-dose chemotherapy) to study week 9 and 18]
- Safety profile evaluated by number of SARs [Time frame: Start of study drug treatment (week 1) until study week 10]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT06449625 · U1111-1277-7868 · 2022-502139-20-00