Semaglutide in Auto-HSCT
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorKlaus Gottlob Müller
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Referral for auto-HSCT for relapsed diffuse large B-cell lymphoma or follicular lymphoma
Age ≥ 18 years
BMI ≥ 18.5
ECOG performance status* ≤ 2
Disqualifiers
Diabetes
Inflammatory bowel disease
Previous or current gastrointestinal malignancy
Personal or family history of medullary thyroid carcinoma or MEN syndrome
Trial design
Design model
Parallel
Treatments tested in this trial
Semaglutide Pen Injector [Ozempic]
DrugSemaglutide active drug
Placebo
Drugsemaglutide placebo
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: SemaglutideActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
gastrointestinal mucositis severity
mean severity grade (0-II)
Time frame
from day of stem cell infusion (day 0) to week +3Secondary outcomes
1
CRP increment
AUC
Time frame
from day of stem cell infusion (day 0) to week +32
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
Time frame
change from baseline (start of high-dose chemotherapy) to study week 9 and 183
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
Time frame
change from baseline (start of high-dose chemotherapy) to study week 9 and 184
Safety profile evaluated by number of SARs
SAR will be estimated according to ICH-GCP guidelines
Time frame
Start of study drug treatment (week 1) until study week 10Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Klaus Gottlob Müller
Lead sponsor
Rigshospitalet, Denmark
Sponsor institution
Novo Nordisk A/S
Collaborator
Independent Research Fund Denmark
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: