Vitamin A and D Supplementation in Allogeneic HCT

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Petersburg State Pavlov Medical University

About this trial

The therapy under investigation is the addition of 300 000 IU of vitamin A and 100 000 IU of vitamin D before conditioning. The study will include patients with malignant diseases in hematologic response with indications for allogeneic transplantation with matched related or matched unrelated donor.

Eligibility criteria

Qualifiers

Diagnosis: acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myeloproliferative disease, chronic myeloid leukemia, lymphoblastic lymphoma, myeloma

Standard disease risk: less than 5% clonal blasts in the bone marrow and the absence of blast forms in the peripheral blood at the time of inclusion in the study or at least partial response for lymphoproliferative neoplasms.

Related compatible donor 10/10 HLA-matched or unrelated compatible donor 9-10/10 HLA-matched

Age ≥18 years

Disqualifiers

- Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 normal;

respiratory failure more than 1 degree. or oxygen dependence

Unstable hemodynamics;

Uncontrolled bacterial or fungal infection at the time of inclusion, despite adequate antibacterial or antifungal therapy (CRP>70 mg/l at the time of inclusion).

Trial design

Treatments tested in this trial

  • Vitamin A
  • Vitamin D3

Treatment groups

220 Participants
are divided into 2 treatment groups