Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06508099

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

RM Gorbacheva Research Institute

Saint Petersburg, Russia, 197022

Actively Recruiting

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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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Vitamin A and D Supplementation in Allogeneic HCT | DecenTrialz