A Study of Letermovir to Prevent a Recurrence of Cytomegalovirus Infection

Full Title

An Open-label, Single-arm Study of Letermovir (LTV) for Prevention of Recurrent CMV Infection in High-risk Hematopoietic Cell Transplant (HCT) Recipients

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. Even if the infection is initially treated successfully, some patients have a high risk of the infection coming back.

In this study, researchers want to see if the drug letermovir is effective for preventing CMV infection from coming back after treatment is completed. 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. Patients in this study will also take acyclovir to prevent infections caused by other viruses. Both medications are 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 already been treated for CMV following a stem cell transplant from a donor and have a high risk of the infection coming back.
  • Patients may not have CMV infection when they enter the study.
  • This study is for patients age 12 and older.

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

Protocol

19-174

Phase

II

Investigator