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Randomized Study of Vitamin A and D Prophylaxis Before Allogeneic Related and Unrelated Hematopoietic Stem Cell Transplantation (VitaStem)
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.
Details
| Lead sponsor | St. Petersburg State Pavlov Medical University |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 220 |
| Start date | 2024-05-15 |
| Completion | 2027-05 |
Conditions
- Acute Lymphoblastic Leukemia
- Acute Myeloid Leukemia
- Biphenotypic Acute Leukemia
- Lymphoblastic Lymphoma
- Chronic Myeloid Leukemia
- Myelodysplastic Syndromes
- Myeloprolipherative Neoplsm
- Non-hodgkin Lymphoma
Interventions
- Vitamin A
- Vitamin D3
Primary outcomes
- Cumulative incidence of gastrointestinal acute GVHD — 125 days
Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and primary graft failure
Countries
Russia