Clinical Trial 23421

• Overview

  Study Title:

  A Randomized Double Blinded Trial of Vitamin A Supplementation in Allogeneic Stem Cell Transplantation

  Summary:

  The investigators hypothesize that single oral high dose supplementation with vitamin A will reduce the incidence of moderate-severe chronic graft-versus-host disease (GVHD) compared with placebo.

  Objective:

  Our main study objective is to reduce the incidence of moderate -severe chronic GVHD in recipients of vitamin A compared to placebo by 1 year post HSCT.

• Treatments

  Therapies:

  Therapy (NOS)

  Medications:

  Placebo (); Vitamin A ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Be 18 years of age or older.
  • Be scheduled for allogeneic stem cell transplant.
  • Have a vitamin A level > Be able to tolerate enteral vitamin dose administration.
  • Have a total bilirubin level > Receiving PBSCs as stem cell graft.
  • Other criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Ongoing raised intracranial pressure.
  • Liver cirrhosis.
  • Patients will be excluded if they are currently pregnant.
  • Other criteria may apply.

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