Status:
RECRUITING
Vitamin A and D Supplementation in Allogeneic HCT
Lead Sponsor:
St. Petersburg State Pavlov Medical University
Conditions:
Acute Lymphoblastic Leukemia
Acute Myeloid Leukemia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 respo...
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. ...
Eligibility Criteria
Inclusion
- 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
- \- 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
Key Trial Info
Start Date :
May 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06508099
Start Date
May 15 2024
End Date
May 1 2027
Last Update
July 31 2024
Active Locations (1)
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1
RM Gorbacheva Research Institute
Saint Petersburg, Russia, 197022