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RecruitingPhase 2NCT06508099

Vitamin A and D Supplementation in Allogeneic HCT

Randomized Study of Vitamin A and D Prophylaxis Before Allogeneic Related and Unrelated Hematopoietic Stem Cell Transplantation

Sponsor

St. Petersburg State Pavlov Medical University

Enrollment

220 participants

Start Date

May 15, 2024

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic LeukemiaAcute Myeloid LeukemiaChronic Myeloid LeukemiaNon-Hodgkin LymphomaMyelodysplastic SyndromesLymphoblastic LymphomaBiphenotypic Acute LeukemiaMyeloprolipherative Neoplsm

Summary

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria11

  • \- 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).
  • Karnofsky index less than 70%
  • Repeated allogeneic transplantation of hematopoietic cells;
  • 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
  • Severe decrease in lung function, FEV1 \<50% or DLCO\<50% predicted
  • Pregnancy
  • Somatic or mental pathology that does not allow signing informed consent

Interventions

DRUGVitamin A

300 000 IU single dose orally

DRUGVitamin D3

100 000 IU single dose orally

Locations(1)

RM Gorbacheva Research Institute

Saint Petersburg, Russia

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NCT06508099

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