Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
150
Countries
1
Sites
1
histiocytic cell proliferation
Determination of molecular status and benefit and safety of use fludeoxyglucose (18-FDG) in PET/CT imagening in juvenile patients with histiocytosis.
Key facts
- Sponsor
- Instytut Matki I Dziecka
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Trial duration
- 15 Apr 2021 → ongoing
- Decision date (initial)
- 2024-08-26
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Medical Research Agency
External identifiers
- EU CT number
- 2024-515895-11-00
- EudraCT number
- 2020-005051-20
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis, Safety
Determination of molecular status and benefit and safety of use fludeoxyglucose (18-FDG) in PET/CT imagening in juvenile patients with histiocytosis.
Secondary objectives 1
- Evaluation of clinical benefit and safety of use fludeoxyglucose (18F-FDG) in PET/CT imagening in juvenile patients with histiocytosis.
Conditions and MedDRA coding
histiocytic cell proliferation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10060801 | Erdheim-Chester disease | 100000004864 |
| 20.0 | PT | 10078782 | Langerhans cell sarcoma | 100000004864 |
| 21.1 | PT | 10063397 | Rosai-Dorfman syndrome | 100000004864 |
| 21.1 | PT | 10069698 | Langerhans' cell histiocytosis | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patient under 18 years of age at the time of inclusion.
- Histopatologically confirmed or suspected histiocytosis (based on prior test results).
- Signing of informed consent for trial participation according with current legal regulations.
Exclusion criteria 3
- Lack of inclusion criteria.
- Pregnancy.
- Other acute or persistent disorders, behaviors or abnormal laboratory test results, which might increase the risk related to the participation in this clinical trial or to taking the study drug, or which might influence the interpretation of the study results, or which, in the investigator's opinion, disqualify a patient from participating in the trial.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- EFS – (event-free survival).
Secondary endpoints 5
- PFS (Progression-Free Survival)
- OS (Overall Survival)
- ORR (Overall Response Rate)
- Reactivation rate after 2 years
- Rate of participants presenting with Adverse Events separated by degree of intensity, category, affected organ or system.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
GLUNEKTIK, 1 GBq/mL, roztwór do wstrzykiwań
PRD5298446 · Product
- Active substance
- Fludeoxyglucose (18F)
- Substance synonyms
- FLUDEOXYGLUCOSE F 18, FLUORODEOXYGLUCOSE F18, ALPHA-D-GLUCOPYRANOSE, 2-DEOXY-2-(FLUORO-18F), 18F-FLUDEOXYGLUCOSE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 6 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 48 MBq/kg megabecquerel(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- V09IX04 — -
- Marketing authorisation
- 23958
- MA holder
- SYNEKTIK S.A.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Fludeoxyglucose (18F) Synektik, 200-2200 MBq/ml, roztwór do wstrzykiwań
PRD7403775 · Product
- Active substance
- Fludeoxyglucose (18F)
- Substance synonyms
- FLUDEOXYGLUCOSE F 18, FLUORODEOXYGLUCOSE F18, ALPHA-D-GLUCOPYRANOSE, 2-DEOXY-2-(FLUORO-18F), 18F-FLUDEOXYGLUCOSE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 6 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 48 MBq/kg megabecquerel(s)/kilogram
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- V09IX04 — -
- Marketing authorisation
- 22788
- MA holder
- SYNEKTIK PHARMA SP. Z O.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instytut Matki I Dziecka
- Sponsor organisation
- Instytut Matki I Dziecka
- Address
- Ul Marcina Kasprzaka 17 A
- City
- Warsaw
- Postcode
- 01-211
- Country
- Poland
Scientific contact point
- Organisation
- Instytut Matki I Dziecka
- Contact name
- Klinika Onkologii i Chirurgii Onkologicznej Dzieci i Młodzieży IMID
Public contact point
- Organisation
- Instytut Matki I Dziecka
- Contact name
- Klinika Onkologii i Chirurgii Onkologicznej Dzieci i Młodzieży IMID
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy ORG-100009191
|
Warsaw, Poland | Other |
| Scientia CRO Sp. z o.o. ORG-100047739
|
Bydgoszcz, Poland | On site monitoring, Code 10, Data management, E-data capture, Code 8, Code 9 |
| Uniwersytet Przyrodniczy we Wrocławiu ORL-000009044
|
Wrocław, Poland | Other |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Ongoing, recruiting | 150 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Poland | 2021-04-15 | 2021-04-15 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 11 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-515895-11-00_for publication_redacted2 | 3.0 |
| Recruitment arrangements (for publication) | Placeholder_transition | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 13-18 yr_for publication_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 18 yr_for publication_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent 9-12 yr | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Assent under 8 yr | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data Protection | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Parents_for publication_redacted | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fludeoxyglucose-Synektik | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_GLUNEKTIK | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2024-515895-11-00_for publication_redacted2 | 3.0 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-16 | Poland | Acceptable 2024-08-19
|
2024-08-26 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-10-30 | Poland | Acceptable 2024-08-19
|
2025-10-30 |