A Study of Brincidofovir versus Standard of Care to Treat Adenovirus Infections in Children after a Donated Stem Cell Transplant

Full Title

An Open-label, Randomized, Multi-center, Parallel Group, Two-arm Study to Assess the Safety, Overall Tolerability, and Antiviral Activity of Brincidofovir versus Standard of Care for Treatment of Adenovirus Infections in High-risk Pediatric Allogeneic Hematopoietic Cell Transplant Recipients (AdAPT; Chimerix No. CMX001-999)

Purpose

Infection with adenovirus is a potential complication of stem cell transplants received from a donor (allogeneic transplant). There is no FDA-approved treatment for adenovirus infection. Sometimes a drug called cidofovir is used to treat this infection. However, cidofovir may cause kidney damage. In this study, researchers are evaluating the use of the drug brincidofovir to treat adenovirus infections in children who have received a stem cell transplant from a donor.

Brincidofovir is a different form of cidofovir and is taken by mouth; it changes into cidofovir inside the body. In previous studies, brincidofovir did not appear to cause kidney damage. Patients in this study will be randomly assigned to receive brincidofovir or a standard treatment for adenovirus (such as cidofovir).

Eligibility

Eligibility:

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have adenovirus following a T cell-depleted allogeneic stem cell transplant.
  • This study is for patients age 2 months to just under 18 years.

For more information about this study and to inquire about eligibility, please contact Dr. Genovefa Papanicolaou at 212-639-8361.

Protocol

18-333

Phase

II

Disease Status

Newly Diagnosed

Investigator

Co-Investigators