Letermovir for Preventing CMV Infection After Bone Marrow Transplant

Recruiting at 1 trial location

Overseen By Yeon Joo Lee, MD

Age: Any Age

Sex: Any

Trial Phase: Phase 2

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Pimozide, Ergot alkaloids, Pitavastatin, Simvastatin

Disqualifiers: Severe hepatic impairment, HIV, HCV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 100

Duration: 14 weeks

102 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to determine of letermovir (LTC) is effective at preventing Cytomegalovirus (CMV) infection from returning in people who have already had CMV infection after a bone marrow transplant.

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

Willing and able to comply with trial instructions and requirements

I've completed treatment for a serious CMV infection within the last 7 days.

I can give my consent, or if under 18, my guardian can and I agree to participate.

Exclusion Criteria

Glomerular filtration rate (GFR) </= mL/min/1.73m^2(equivalent to creatinine clearance </=10 mL/min)

I have received up to two doses of IV cidofovir for ADV.

I use high-dose antiviral medication regularly, but only short treatments for severe infections.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive letermovir for 14 weeks to prevent recurrent CMV infection

14 weeks

Weekly visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Visits on day 100 and day 180 for blood sample collection

What Are the Treatments Tested in This Trial?

Interventions

• Letermovir

Trial Overview The study tests whether Letermovir pills can prevent the recurrence of Cytomegalovirus (CMV) infection in patients who've previously been treated for CMV after receiving a bone marrow transplant. Participants will take Letermovir and undergo regular blood draws to monitor their health.

How Is the Trial Designed?

Group I: Hematopoietic cell transplantation/HCT Experimental Treatment 2 Interventions

Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity. OBSERVATIONAL COHORT: Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.

Letermovir is already approved in United States, European Union for the following indications:

Approved in United States as Prevymis for:

• 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-])

Approved in European Union as Prevymis for:

• 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-])

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

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