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NCT06508099RecruitingPhase 2

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

Source: ClinicalTrials.gov · Last updated 31 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
220 (estimated)
First submitted
12 Jul 2024
Start date
15 May 2024
Primary completion date
May 2026
Lead sponsor
St. Petersburg State Pavlov Medical University
NCT number
NCT06508099

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 220
  • From 15 May 2024 to the primary completion date, May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Repeated allogeneic transplantation of hematopoietic cells;

Other illness

  • 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).

Lab values

  • \- 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
RM Gorbacheva Research Institute
Coordinator of this site? Confirm its status
Saint PetersburgRussiaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.