Semaglutide in Auto-HSCT

Inflammation Clinical Trial

— PROTECT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06449625
• Other study ID #: U1111-1277-7868
• Secondary ID: 2022-502139-20-0
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 12, 2024
• Est. completion date: February 1, 2027

Study information

• Verified date: June 2024
• Source: Rigshospitalet, Denmark
• Contact: Maria Ebbesen Sørum, MD, PhD
• Phone: 004540638545
• Email: maria.ebbesen.soerum[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 1, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapeutic Toxicity
• Inflammation
• Mucositis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Klaus Gottlob Müller	Independent Research Fund Denmark, Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	gastrointestinal mucositis severity	mean severity grade (0-II)	from day of stem cell infusion (day 0) to week +3
Secondary	CRP increment	AUC	from day of stem cell infusion (day 0) to week +3
Secondary	Quality of life general	evaluated by EORTC QLQ-C30 questionnaire. The QLQ-C30 summary score is calculated as the mean of the combined 13 QLQ-C30 scale and item scores (excluding global QoL and financial impact). Final scoring range: 0-100 with a higher score indicating a better quality of life	change from baseline (start of high-dose chemotherapy) to study week 9 and 18
Secondary	Quality of life - high-dose chemotherapy treatment specific	evaluated by EORTC QLQ-HDC29 questionnaire. The QLQ HDC29 module includes 29 items, consisting of 6 multi-item scales and 8 singleitems. Final scoring range: 0-100 with a higher score indicating a better quality of life	change from baseline (start of high-dose chemotherapy) to study week 9 and 18
Secondary	Safety profile evaluated by number of SARs	SAR will be estimated according to ICH-GCP guidelines	Start of study drug treatment (week 1) until study week 10