No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
220 (estimated)
Sponsor
St. Petersburg State Pavlov Medical University · Other
Who this trial is looking for
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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.
Trial Locations
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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 bl…
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
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