Letermovir for Preventing CMV Infection After Bone Marrow Transplant
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if letermovir (Prevymis) can prevent the return of Cytomegalovirus (CMV) infection in individuals who have undergone a bone marrow transplant. It targets those who have previously had CMV and completed specific treatments after their transplant no more than a week ago. Individuals concerned about CMV recurrence after a bone marrow transplant might be suitable candidates. Participants will take letermovir for 14 weeks, with regular blood tests to monitor the virus. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.
Do I have to stop taking my current medications for the trial?
The trial does not specify that you must stop all current medications, but certain medications are not allowed. You cannot take high doses of acyclovir, valacyclovir, or famciclovir, and some medications like pimozide, ergot alkaloids, and certain statins are not allowed with letermovir. Check with the trial team to see if your current medications are compatible.
Is there any evidence suggesting that letermovir is likely to be safe for humans?
Research has shown that letermovir is generally safe for individuals who have undergone a bone marrow transplant. One study found that letermovir effectively prevents CMV (Cytomegalovirus) infection and has few harmful side effects. Another review confirmed its safety in preventing CMV reactivation after a transplant. These findings suggest that letermovir is well-tolerated and could be a good option for preventing CMV infections.12345
Why do researchers think this study treatment might be promising?
Letermovir is unique because it specifically targets the CMV virus, preventing its reactivation in patients who have undergone bone marrow transplants. Unlike the standard antiviral treatments like ganciclovir or foscarnet, which can have significant side effects like bone marrow suppression, letermovir offers a more tolerable safety profile. Researchers are excited about this treatment because it provides an effective prophylactic option without the common toxicities associated with other antivirals, potentially improving patients' overall quality of life post-transplant.
What evidence suggests that letermovir is effective for preventing CMV infection after a bone marrow transplant?
Research shows that letermovir, which participants in this trial will receive, effectively prevents Cytomegalovirus (CMV) from reactivating after a bone marrow transplant. Studies have found that letermovir significantly reduces the risk of CMV appearing in the blood. Known for its low toxicity, letermovir is safer for long-term use. Real-world data supports its success in preventing serious CMV infections in transplant patients. Overall, letermovir is a promising option for those at risk of CMV reactivation after a transplant.12678
Who Is on the Research Team?
Genovefa Papanicolaou, MD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals aged 12 or older who have had a bone marrow transplant, received treatment for CMV infection post-transplant, and are at risk of the infection returning. They must be able to consent (or have a guardian consent), follow trial procedures, and use effective contraception if applicable. People with severe kidney or liver issues, certain drug interactions, HIV/HCV/HBsAg positivity, need for intensive care support, pregnancy/breastfeeding intentions during the trial period cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive letermovir for 14 weeks to prevent recurrent CMV infection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Letermovir
Letermovir is already approved in United States, European Union for the following indications:
- Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
- Prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
- Prophylaxis of cytomegalovirus (CMV) infection and disease in adult and pediatric patients 6 months of age and older and weighing at least 6 kg who are CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
- Prophylaxis of cytomegalovirus (CMV) disease in adult and pediatric patients 12 years of age and older and weighing at least 40 kg who are kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
- Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT)
- Prophylaxis of cytomegalovirus (CMV) disease in adult kidney transplant recipients at high risk (Donor CMV seropositive/Recipient CMV seronegative [D+/R-])
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University