A Phase IIB Study Evaluating Letermovir in Children and Teens at Risk of Cytomegalovirus Infection after Receiving a Stem Cell Transplant

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Full Title

A Phase 2b Open-Label, Single-Arm Study to Evaluate Pharmacokinetics, Efficacy, Safety and Tolerability of Letermovir in Pediatric Participants from Birth to Less than 18 Years of Age at Risk of Developing CMV Infection and/or Disease Following Allogeneic Haematopoietic Stem Cell Transplantation (HSCT)

Purpose

Cytomegalovirus (CMV) is a potential complication after a stem cell transplant from a donor. It can cause serious infections, due to patients’ recovering immune systems. There are drugs used to treat CMV, but the virus becomes resistant to these drugs in some patients or the patient cannot tolerate the side effects.

In this study, researchers want to assess the safety of the drug letermovir in children and teens who have received a stem cell transplant from a donor and are at risk of CMV infection, and to see if this medication can prevent CMV. The side effects of this medication may be less severe than those caused by valganciclovir, ganciclovir, or foscarnet (other CMV drugs). Letermovir stops CMV from reproducing in a different way than these drugs. It is taken orally (by mouth).

Eligibility

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

  • Patients must have received a stem cell transplant from a donor within 4 weeks of entering the study.
  • Patients may not have CMV infection when they enter the study and may not have previously received CMV medications.
  • This study is for patients under 18 years old.

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

Protocol

19-211

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators