Letermovir for Preventing Infection in Blood Cancer Patients

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ohio State University Comprehensive Cancer Center

Must be taking: Alemtuzumab

Must not be taking: Ganciclovir, Valganciclovir, Foscarnet, others

Disqualifiers: CMV disease, HIV, Hepatitis B, 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: 1

Duration: 3 months

6 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial studies how well letermovir prevents CMV reactivation in patients with blood cancers treated with alemtuzumab. Letermovir works by stopping the virus from making more copies of itself. The goal is to see if it can effectively prevent CMV infections in these patients. Letermovir is an antiviral drug approved for preventing CMV infections, primarily studied for a few months after treatment.

Research Team

John C Reneau, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with certain blood cancers (like leukemia or lymphoma) who are being treated with alemtuzumab and have a risk of cytomegalovirus reactivation. They must not be pregnant, should agree to use birth control, and cannot have severe kidney or liver problems, recent CMV disease, HIV with low CD4 count, or be on conflicting medications.

Inclusion Criteria

I have been diagnosed with a specific type of leukemia or lymphoma.

Confirmed lack of active CMV infection as evidenced by:

I am a woman who cannot become pregnant.

Exclusion Criteria

I am currently taking or have taken Ganciclovir.

I have received CMV hyper-immune globulin.

I am not taking Pimozide.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive letermovir daily on days 1-28, with cycles repeating every 28 days for up to 3 months after the last dose of alemtuzumab

3 months

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

1 visit (in-person)

Long-term follow-up

Participants are monitored for progression free survival and overall survival

Up to 2 years

Treatment Details

Interventions

• Letermovir

Trial Overview The study tests if letermovir can prevent cytomegalovirus (CMV) infection in patients receiving alemtuzumab for blood cancers. It's a phase II trial where the effectiveness of letermovir as a preventive measure against CMV reactivation is being evaluated.

Participant Groups

Group I: Treatment (letermovir) Experimental Treatment 1 Intervention

Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity.

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?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

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