Vitamin A and D Supplementation in Allogeneic HCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vitamin A, Vitamin D3.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Biphenotypic Acute Leukemia, Lymphoblastic Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Randomized Study of Vitamin A and D Prophylaxis Before Allogeneic Related and Unrelated Hematopoietic Stem Cell Transplantation
Overview
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.
Detailed description
Currently there is an emerging evidence of gut microbiota role in major complications of HCT, including GVHD, oral mucositis, infectious complications due to multi-drug resistant bacteria in the gut. Early exhaustion of most intestinal bacterial phyla after HSCT is documented in many studies. This effect of intensive anti-infectious therapy is well known. Most authors explain the disruption of intestinal microbiota by massive antibiotic treatment in order to prevent infectious complications due to immune deficiency following HCT. Early decrease in anaerobic bacteria (phylum Firmicutes) is revealed in many studies, with subsequent recovery of these bacterial populations within next 2 months. This time dynamics is in accordance with reported data on depletion of certain anaerobic gut bacteria, e.g., Ruminococcus, Faecalibacterium spp., Roseburia, Blautia post-transplant, being associated with severe complications in HCT patients. These results are in accordance with severe posttransplant dysbiosis at different mucosal sites post-HCT, as shown elsewhere by routine bacteriology techniques. The metabolism of bacteria with positive effect on GVHD includes both vitamin D and vitamin A. It was demonstrated that Ruminococcus abundance is dependent on vitamin A and D intake. Another bacteria genera Faecalibacterium prausnitzii, which is also reported to produce butyrate and reduce GVHD is also dependent on abundance of vitamin A. The big phylum Firmicutes are also dependant on vitamin D and their abundance is reported to be associated with lower incidence of immune complications and suppression of antibiotic-resistant strains. To summarize the idea of the study is based on modulation of gut microbiota, which in term may result in lower incidence of GVHD and toxic complications of HCT.
Interventions
- Drug Vitamin A
300 000 IU single dose orally - Drug Vitamin D3
100 000 IU single dose orally
Primary outcome measures
- Cumulative incidence of gastrointestinal acute GVHD [Time frame: 125 days]
Secondary outcome measures (9)
- Incidence of HSCT-associated adverse events [Time frame: 125 days]
- Infectious complications [Time frame: 125 days]
- Overall survival [Time frame: 2 years]
- Event-free survival [Time frame: 2 years]
- Overall cumulative incidence of acute GVHD grade II-IV [Time frame: 125 days]
- Incidence of moderate and severe chronic GVHD [Time frame: 2 years]
- Non-relapse mortality analysis [Time frame: 2 years]
- GVHD-relapse-free survival analysis [Time frame: 2 years]
- Cumulative incidence of primary and secondary graft failure [Time frame: 125 days]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- RM Gorbacheva Research Institute — Saint Petersburg
Identifiers
NCT: NCT06508099 · 18/24-n