Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
140
Countries
1
Sites
1
VASCULAR MALFORMATION
To determine the efficacy and feasibility of BEST in the treatment of low-flow vascular malformations.
Key facts
- Sponsor
- Institute Of Oncology Ljubljana
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16], Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Decision date (initial)
- 2026-04-07
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Others, Therapy, Efficacy
To determine the efficacy and feasibility of BEST in the treatment of low-flow vascular malformations.
Secondary objectives 4
- Effectiveness of BEST 12 months after the treatment
- Feasibility of recruitment and treatment according to the Current Operating Procedures
- Safety and tolerability of BEST
- Quality of life
Conditions and MedDRA coding
VASCULAR MALFORMATION
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 26.0 | PT | 10074979 | Vascular malformation | 100000004850 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Patients with low-flow vascular malformations (venous, lymphatic, capillary or mixed type malformations),
- Patients with a low-flow vascular malformation poorly responding or recurring after previous treatment(s).
- Technical feasibility of the BEST procedure, i.e.: injection of bleomycin and safe placement of electrodes into the vascular malformation are technically feasible.
- age ≥ 18
- longer lesion diameter not exceeding 25 cm.
- more than one lesion can be treated. The limiting factor is the maximal dose per patient per treatment session; 10 000 IU in adults,
- skin or mucosal, superficial or deep-seated lesions can be treted,
Exclusion criteria 10
- Pregnancy and lactation
- in adults, previous bleomycin exposure with a cumulative dose greater than 100 000 IU. In case of abnormal respiratory results/chest pathology (including previous severe or long COVID) in consultation with a pulmonologist, special care is required, and bleomycin exposure may be contraindicated,
- In case of abnormal respiratory results/chest pathology (including previous severe or long COVID) in consultation with a pulmonologist, special care is required, and bleomycin exposure may be contraindicated.
- Known allergy or hypersensitivity to bleomycin.
- Presence of significant central venous drainage precluding sclerotherapy.
- women of childbearing potential and men not using reliable contraceptive,
- acute lung infection or severely reduced lung function,
- bleomycin-related lung toxicity or reduced lung function which can indicate bleomycin-related lung toxicity,
- ataxia telangiectasia,
- chronic renal dysfunction.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To evaluate effectiveness of BEST in reducing lesion volume, as measured by MRI 3 months after the treatment in patients with low-flow vascular malformations.
Secondary endpoints 4
- Assessment of the effectiveness of BEST 12 months after the treatment.
- Feasibility of recruitment and treatment according to the Current Operating Procedures
- Safety and tolerability: Incidence, severity and relationship of treatment-emergent adverse events classified accordint to MedDRA and graded using CTCEA v5.0
- Quality of life: QoL assessment with clinically validated OVAMA questioner.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Bleomycin medac, 15 000 RÜ süstelahuse pulber
PRD573625 · Product
- Active substance
- Bleomycin Sulfate Ph. Eur.
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 30 mg/kg milligram(s)/kilogram
- Max total dose
- 30 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DC01 — BLEOMYCIN
- Marketing authorisation
- 730011
- MA holder
- MEDAC GESELLSCHAFT FÜR KLINISCHE SPEZIALPRÄPARATE MBH (WEDEL)
- MA country
- Estonia
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Institute Of Oncology Ljubljana
2
Total trials
Academic / Non-commercial
- Sponsor organisation
- Institute Of Oncology Ljubljana
- Address
- Zaloska Cesta 2
- City
- Ljubljana
- Postcode
- 1000
- Country
- Slovenia
Scientific contact point
- Organisation
- Institute Of Oncology Ljubljana
- Contact name
- Gregor Serša
Public contact point
- Organisation
- Institute Of Oncology Ljubljana
- Contact name
- Neža Gros
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Slovenia | Authorised, recruitment pending | 140 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | BEST_Clinical Trial Protocol_v3_31Mar2026_FINAL | 3 |
| Protocol (for publication) | BEST_Clinical Trial Protocol_v4_20May2026_cistopis | 4 |
| Protocol (for publication) | BEST_Clinical Trial Protocol_v4_20May2026_track changes | 4 |
| Protocol (for publication) | protokol_BEST_AM 1_11Mar2026_FINAL | 2 |
| Protocol (for publication) | protokol_BEST30092025 | 1 |
| Recruitment arrangements (for publication) | informedconsent_patientrecruitmentprocedure_en | 1 |
| Subject information and informed consent form (for publication) | BEST_Informacije o raziskavi + soglasje za odrasle_V3_20May2026_cistopis | 3 |
| Subject information and informed consent form (for publication) | BEST_Informacije o raziskavi + soglasje za odrasle_V3_20May2026_track changes | 3 |
| Subject information and informed consent form (for publication) | BEST_Informacije o raziskavi in soglasje za odrasle_V3_20May2026_cistopis | 3 |
| Subject information and informed consent form (for publication) | BEST_Informacije o raziskavi in soglasje za odrasle_1Apr26_FINAL | 2 |
| Subject information and informed consent form (for publication) | BEST_Informacije o raziskavi in soglasje za odrasle_V3_20May2026_track changes | 3 |
| Subject information and informed consent form (for publication) | OVAMA symptoms and appearance and satisfaction English | 1 |
| Subject information and informed consent form (for publication) | OVAMA-prevod_KONCNA VERZIJA_2_z nagovorom | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Bleomicin_medac-spc-si | 1 |
| Synopsis of the protocol (for publication) | Protocol synopsis_SI | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-01-05 | Slovenia | Acceptable 2026-04-07
|
2026-04-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-05-21 | Slovenia | Acceptable 2026-04-07
|
2026-05-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-05-25 | Slovenia | Acceptable 2026-04-07
|
2026-05-25 |