Clinical trial · Interventional
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
NCT06508099CI-TRIAL-00079320VitaStemrecruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Biphenotypic Acute Leukemia | — | UNRESOLVED | — |
| Chronic Myeloid Leukemia | Chronic Myeloid Leukemia, BCR-ABL1 Positive | ALIAS | 0.90 |
| Lymphoblastic Lymphoma | Lymphoblastic Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloprolipherative Neoplsm | — | UNRESOLVED | — |
| Non-hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vitamin A | Drug | — | UNRESOLVED |
| Vitamin D3 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Vitamin supplementation
- description
- vitamin A 300 000 IU and vitamin D 100 000 IU on days -14 to -8 before transplantation
- interventionNames
- Drug: Vitamin A
- Drug: Vitamin D3
- type
- NO_INTERVENTION
- label
- Routine care
- description
- Routine care
Primary outcomes (1)
- measure
- Cumulative incidence of gastrointestinal acute GVHD
- timeFrame
- 125 days
- description
- Cumulative incidence of patients with acute GVHD II-IV grade, competing risk is death, relapse and primary graft failure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.