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Delfa

← All trials/NCT06449625

PROTECT

Not yet recruitingPhase 2

Semaglutide in Auto-HSCT

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

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

0

Recruiting sites

-

Estimated enrollment

40

Study population

Oncology

Eligibility highlights

•BMI ≥18.5

Primary endpoint

•Gastrointestinal mucositis severity

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06449625
Org study IDU1111-1277-7868
Secondary ID2022-502139-20-00

Timeline

Milestones

Study first posted2024-06-10actual
Last update posted2024-06-10actual
Study start2024-08-12estimated
Primary completion2026-12-31estimated
Study completion2027-02-01estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Oncology

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Patient-reported / QoL
2
Safety / tolerability / PK
2
Cardiometabolic biomarkers
1

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

CRP increment

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

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Quality of life general

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

change from baseline, improvement

Secondary/protocol endpoint

Quality of life - high-dose chemotherapy treatment specific

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

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

gastrointestinal mucositis severity

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

descriptive, event

Secondary/protocol endpoint

Safety profile evaluated by number of SARs

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

event count, event

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.