Vitamin A and D Before Stem Cell Transplant for Blood Cancers
Tests vitamin A and vitamin D given before transplant in adults with blood cancers.
Plain-language title generated from the registry record
Registry title: Vitamin A and D Supplementation in Allogeneic HCT
Key facts
- Where
- Saint Petersburg, RussiaSee the site
- Phase
- Phase 2
Where in Russia
- RM Gorbacheva Research InstituteSaint Petersburg, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- St. Petersburg State Pavlov Medical University
- Trial code
- NCT06508099
- Record updated
- 31 July 2024
- Original description
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.Read full original descriptionShow less
Randomized Study of Vitamin A and D Prophylaxis Before Allogeneic Related and Unrelated Hematopoietic Stem Cell Transplantation
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.
Inclusion: 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; Absence of severe concomitant somatic diseases.
Exclusion: Repeated allogeneic transplantation of hematopoietic cells; respiratory failure more than 1 degree. or oxygen dependence; 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); - Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 normal; Creatinine clearance below 60ml/min/1.73m2; Severe cardiac pathology, including a decrease in ejection fraction less than <50%, unstable angina, exertional angina of III-IV functional class, heart failure of III-IV functional class, arrhythmia grade V according to Lawn; Unstable hemodynamics; Karnofsky index less than 70%; Severe decrease in lung function, FEV1 <50% or DLCO<50% predicted; Pregnancy; Somatic or mental pathology that does not allow signing informed consent.