NCT06508099 Vitamin A and D Supplementation in Allogeneic HCT
| NCT ID | NCT06508099 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | St. Petersburg State Pavlov Medical University |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 220 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2026-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 220 participants in total. It began in 2024-05-15 with a primary completion date of 2026-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 response with indications for allogeneic transplantation with matched related or matched unrelated donor.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06508099 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06508099 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06508099 currently recruiting?
Yes, NCT06508099 is actively recruiting participants. Contact the research team at moisiv@mail.ru for enrollment information.
Where is the NCT06508099 trial being conducted?
This trial is being conducted at Saint Petersburg, Russia.
Who is sponsoring the NCT06508099 clinical trial?
NCT06508099 is sponsored by St. Petersburg State Pavlov Medical University. The trial plans to enroll 220 participants.
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