Vitamin A and D supplementation for patients undergoing allogeneic hematopoietic transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of adding 300,000 IU of vitamin A and 100,000 IU of vitamin D before conditioning in patients with hematologic malignancies who are candidates for allogeneic hematopoietic transplantation. The research focuses on the role of gut microbiota in complications following transplantation, such as graft-versus-host disease (GVHD) and infections. By enhancing the intake of these vitamins, the study aims to improve the abundance of beneficial gut bacteria that may mitigate severe complications post-transplant. Eligible participants include those with specific types of leukemia and lymphoma who have a compatible donor.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* \- 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

Where it's running

• RM Gorbacheva Research Institute
  Saint Petersburg, Russia Recruiting

Study contacts

• Study coordinator: Ivan Sergeevich Moiseev
• Email: moisiv@mail.ru
• Phone: +78123386265

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.