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.
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
- 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).
Parallel
Vitamin A
Drug300 000 IU single dose orally
Vitamin D3
Drug100 000 IU single dose orally
Cumulative incidence of gastrointestinal acute GVHD
Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and primary graft failure
Incidence of HSCT-associated adverse events
Toxicity assessment is based on presence of NCI CTC AE 5.0 event grades 3-5. Veno-occlusive disease incidence and severity assessment is based on EBMT criteria 2020. Transplant-associated microangiopathy incidence assessment is based on Harmonization criteria. All toxicity measurements will be aggregated as severity scores
Infectious complications
Incidence of infections, including analysis of severe bacterial, fungal and viral infections incidence
Overall survival
Kaplan-Meier estimate of either relapse, primary or secondary graft failure or death from all causes
Event-free survival
Kaplan-Meier estimate of either relapse, primary or secondary graft failure or death from all causes
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