Letermovir for Preventing Infection in Blood Cancer Patients

Overseen By The Ohio State University Comprehensive Cancer Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

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.

Treatment Details

Interventions

• Letermovir (Virus Therapy)

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.

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