Actively Recruiting
Vitamin A and D Supplementation in Allogeneic HCT
Led by St. Petersburg State Pavlov Medical University · Updated on 2024-07-31
220
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Vitamin A and D Supplementation in Allogeneic HCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome, chronic myeloproliferative disease, chronic myeloid leukemia, lymphoblastic lymphoma, or myeloma
- Standard disease risk with less than 5% clonal blasts in bone marrow and no blast forms in peripheral blood, or at least partial response for lymphoproliferative neoplasms
- Compatible related donor with 10/10 HLA match or compatible unrelated donor with 9-10/10 HLA match
- Age 18 years or older
- No severe concomitant somatic diseases
You will not qualify if you...
- Severe organ failure: creatinine more than 2 times normal; ALT or AST more than 5 times normal; bilirubin more than 1.5 times normal
- Respiratory failure grade more than 1 or oxygen dependence
- Unstable hemodynamics
- Uncontrolled bacterial or fungal infection despite adequate therapy (CRP >70 mg/l)
- Karnofsky performance index less than 70%
- Repeat allogeneic hematopoietic cell transplantation
- Creatinine clearance below 60 ml/min/1.73 m2
- Severe cardiac disease including ejection fraction less than 50%, unstable angina, severe heart failure, or severe arrhythmia
- Severe lung function decrease (FEV1 <50% or DLCO <50% predicted)
- Pregnancy
- Somatic or mental conditions that prevent signing informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
RM Gorbacheva Research Institute
Saint Petersburg, Russia, 197022
Actively Recruiting
Research Team
I
IVAN SERGEEVICH MOISEEV
CONTACT
I
Irina Сергеевич Bykova
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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