Clinical trial • Phase II • Haematology

Colecalciferol for Graft-versus-host disease (acute and chronic) | Haematologic condition requiring allogeneic stem cell transplantation

Phase II trial of Colecalciferol for Graft-versus-host disease (acute and chronic) | Haematologic condition requiring allogeneic stem cell transplantation.

Overview

Trial Therapeutic Area
Haematology
Trial Disease
Graft-versus-host disease (acute and chronic) | Haematologic condition requiring allogeneic stem cell transplantation
Trial Stage
Phase II
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
16-10-2024
First CTIS Authorization Date
19-11-2024

Trial design

Randomised, open-label, none/not specified-controlled Phase II trial across 1 site in Italy.

Randomised
Yes
Open Label
Yes
Comparator
None/Not specified
Target Sample Size
20

Eligibility

Recruits 20 No vulnerable population selected. Participants must be legally capable of providing informed consent; subjects who are not deemed legally capable of consent are excluded. Informed consent is required..

Pregnancy Exclusion
In the case of female: sex pregnancy and/or lactation.
Vulnerable Population
No vulnerable population selected. Participants must be legally capable of providing informed consent; subjects who are not deemed legally capable of consent are excluded. Informed consent is required.

Inclusion criteria

  • {"criterion_text":"- Patients aged > 18 years. Male and female\n- Diagnosis of any oncohematologic disease with transplant indication, also allowed patients not in clinical response\n- Patients undergoing allogeneic stem cell transplantation regardless of conditioning regimen and HSC source\n- Ability to sign informed consent"}

Exclusion criteria

  • {"criterion_text":"- Transplantation from T-depleted or T-selected product\n- Documented intolerance to the drug or any of its excipients\n- Ongoing vitamin D therapy for any medical condition\n- Hypercalcemia, hypercalciuria, kidney stones, renal failure\n- Age < 18 years\n- Subjects who are not deemed legally capable of consent.\n- In the case of female: sex pregnancy and/or lactation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Reducing the severity of GVHD","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Evaluation of circulating lymphocyte subpopulations on peripheral blood\n- Assessment of vitamin D receptor (VDR) surface expression and modulation in response to vitamin D treatment on lymphocyte subpopulations.\n- Evaluation of the soluble fraction of VDR on serum\n- post hoc evaluation of the role of polymorphisms (SNPs) of recipient and donor VDR on response to vitamin D therapy\n- collection of any adverse events brought about by cholecalciferol intake","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
20
Recruitment Window Months
36
Consent Approach
Informed consent is required from each participant; the protocol requires the ability to sign informed consent and excludes subjects not legally capable of consent. A subject information and informed consent form document is present (TI consenso vit D v4 09102024). No assent process or participant-language specifics are provided in the available data.

Geography

Total Number Of Sites
1
Total Number Of Participants
20

Italy

Earliest CTIS Part Ii Submission Date
04-10-2024
Latest Decision Or Authorization Date
19-11-2024
Processing Time Days
46
Number Of Sites
1
Number Of Participants
20

Sites

Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
U.O. Ematologia
Contact Person Name
Sara Galimberti
Contact Person Email
sara.galimberti@unipi.it
Number Of Participants
20

Sponsor

Primary sponsor

Full Name
Azienda Ospedaliero Universitaria Pisana
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Italy

Third parties

  • {"country":"","full_name":"S.P.A: Società Prodotti Antibiotici","duties_or_roles":"Source of monetary support","organisation_type":""}

Investigational products

Investigational Product Name
TREDIMIN 25.000 U.I. /2,5 ml soluzione orale
Active Substance
Colecalciferol
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
Authorised (marketing authorisation in Italy)
Maximum Dose
5000 IU per day

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