Role of Vitamin D in patients undergoing allogeneic stem cell transplantation. Pilot study

Phase 1

• Conditions: Treatment of acute and chronic graft versus host disease (GVHD) after allogeneic donor hematopoietic stem cell transplantation in adult patients with haematological diseases.; MedDRA version: 20.0Level: LLTClassification code 10068908Term: AGVHDSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2020-003994-23-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-04
• Last Update Posted: 2 March 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- age > 18 years old
- Diagnosis of any oncohematological pathology with transplant indication; patients not in clinical response allowed
- Patients undergoing allogeneic stem cell transplantation regardless of the conditioning regimen and source of CSE
- ability to sign informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8

Exclusion Criteria

- Transplant from T-depleted or T-selected product
- Documented intolerance to the drug or to one of its excipients;
- Ongoing vitamin D therapy for any medical conditions;
- Hypercalcemia, hypercalciuria, kidney stones, renal failure;
- age < 18 years
- Subjects who are not legally deemed capable of understanding and willing.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified