Vitamin A and D supplementation for patients undergoing allogeneic hematopoietic transplantation

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

This study is testing if giving high doses of vitamins A and D before a stem cell transplant can help patients with certain blood cancers have fewer complications like infections and graft-versus-host disease.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: St. Petersburg State Pavlov Medical University (Academic / other)
• Locations: 1 site (Saint Petersburg)
• Trial ID: NCT06508099 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific hematologic malignancies and a compatible donor for transplantation.

Not a fit: Patients with severe organ failure or uncontrolled infections at the time of inclusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce complications and improve outcomes for patients undergoing allogeneic hematopoietic transplantation.

How similar studies have performed: While the role of gut microbiota in transplantation is being explored, this specific approach of vitamin supplementation is relatively novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Saint Petersburg

• RM Gorbacheva Research Institute — Saint Petersburg, Russia (Recruiting)

Study contacts

• Study coordinator: Ivan Sergeevich Moiseev

Conditions Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Biphenotypic Acute Leukemia; Lymphoblastic Lymphoma; Chronic Myeloid Leukemia; Myelodysplastic Syndromes; Myeloprolipherative Neoplsm; Non-hodgkin Lymphoma