Overview
Sponsor-declared trial summary
haematologic condition who need staminal cells transplant
Evaluation of the effectiveness of vitamin D on the degree si severity of acute and chronic GvHD
Key facts
- Sponsor
- Azienda Ospedaliero Universitaria Pisana
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Decision date (initial)
- 2024-11-19
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- S.P.A: Società Prodotti Antibiotici
External identifiers
- EU CT number
- 2024-518738-97-00
- EudraCT number
- 2020-003994-23
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
Evaluation of the effectiveness of vitamin D on the degree si severity of acute and chronic GvHD
Secondary objectives 1
- - Assessment of variation in circulating lymphocyte subpopulations on peripheral blood - Assessment of vitamin D receptor surface expression (VDR) and modulation in response to vitamin D treatment on lymphocyte subpopulations. - Evaluation of any adverse events brought about by cholecalciferol intake.
Conditions and MedDRA coding
haematologic condition who need staminal cells transplant
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10019426 | Hematologic disorder | 10005329 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- - Patients aged > 18 years. Male and female - Diagnosis of any oncohematologic disease with transplant indication, also allowed patients not in clinical response - Patients undergoing allogeneic stem cell transplantation regardless of conditioning regimen and HSC source - Ability to sign informed consent
Exclusion criteria 1
- - Transplantation from T-depleted or T-selected product; - Documented intolerance to the drug or any of its excipients; - Ongoing vitamin D therapy for any medical condition; -Hypercalcemia, hypercalciuria, kidney stones, renal failure; - Age < 18 years - Subjects who are not deemed legally capable of consent. - In the case of female: sex pregnancy and/or lactation.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Reducing the severity of GVHD
Secondary endpoints 1
- - Evaluation of circulating lymphocyte subpopulations on peripheral blood - Assessment of vitamin D receptor (VDR) surface expression and modulation in response to vitamin D treatment on lymphocyte subpopulations. - Evaluation of the soluble fraction of VDR on serum - post hoc evaluation of the role of polymorphisms (SNPs) of recipient and donor VDR on response to vitamin D therapy - collection of any adverse events brought about by cholecalciferol intake
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
TREDIMIN 25.000 U.I. /2,5 ml soluzione orale
PRD7966153 · Product
- Active substance
- Colecalciferol
- Pharmaceutical form
- ORAL SOLUTION
- Route of administration
- ORAL USE
- Max daily dose
- 5000 IU/mg international unit(s)/milligram
- Max total dose
- 525000 IU/mg international unit(s)/milligram
- Max treatment duration
- 105 Day(s)
- Authorisation status
- Authorised
- ATC code
- A11CC05 — COLECALCIFEROL
- Marketing authorisation
- 042753032
- MA holder
- SPA – SOCIETÀ PRODOTTI ANTIBIOTICI S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Ospedaliero Universitaria Pisana
- Sponsor organisation
- Azienda Ospedaliero Universitaria Pisana
- Address
- Via Roma 67
- City
- Pisa
- Postcode
- 56126
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Ospedaliero Universitaria Pisana
- Contact name
- Clinical Trial Center
Public contact point
- Organisation
- Azienda Ospedaliero Universitaria Pisana
- Contact name
- Clinical Trial Center
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 20 | 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 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Prot Vit D 2024-518738-97-00 | 4 |
| Recruitment arrangements (for publication) | Document not required under the CT Directive 2001 | 1 |
| Subject information and informed consent form (for publication) | TI consenso vit D v4 09102024 | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | Document not submitted under the CT Directive 2001_20_EC | 00 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-16 | Italy | Acceptable 2024-11-11
|
2024-11-19 |