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NCT Number: NCT06449625

Semaglutide in Auto-HSCT

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.

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Key information

Conditions

Intestinal Mucositis Chemotherapeutic Toxicity Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Semaglutide Pen Injector [Ozempic]

Drug

Semaglutide active drug

Placebo

Drug

semaglutide placebo

Primary outcomes

  1. gastrointestinal mucositis severity

    Time frame: from day of stem cell infusion (day 0) to week +3

    mean severity grade (0-II)

Secondary outcomes

  1. CRP increment

    Time frame: from day of stem cell infusion (day 0) to week +3

    AUC

  2. Quality of life general

    Time frame: change from baseline (start of high-dose chemotherapy) to study week 9 and 18

    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

  3. Quality of life - high-dose chemotherapy treatment specific

    Time frame: change from baseline (start of high-dose chemotherapy) to study week 9 and 18

    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

  4. Safety profile evaluated by number of SARs

    Time frame: Start of study drug treatment (week 1) until study week 10

    SAR will be estimated according to ICH-GCP guidelines

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Sponsors and collaborators

Lead sponsor

Klaus Gottlob Müller

Other

Collaborators

  • Independent Research Fund Denmark
  • Novo Nordisk A/S

Registry information

Official study title

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

Acronym: PROTECT

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jun 10, 2024
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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