Letermovir for Preventing Infection in Blood Cancer Patients
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests letermovir to determine if it can prevent cytomegalovirus (CMV) infections in individuals with blood cancers like leukemia and lymphoma who receive alemtuzumab. Alemtuzumab can reactivate the CMV virus, leading to infections. Letermovir aims to stop the virus from multiplying and causing issues. Individuals may qualify if they have a specific type of blood cancer and plan to start alemtuzumab treatment. As a Phase 2 trial, this research measures letermovir's effectiveness in an initial, smaller group, allowing participants to contribute to important findings.
Do I need to stop my current medications to join the trial?
The trial requires you to stop certain medications, such as ganciclovir, valganciclovir, and others listed, within 7 days before joining. If you're on any of these, you'll need to stop them to participate.
Is there any evidence suggesting that letermovir is likely to be safe for humans?
Research has shown that letermovir is generally safe for people. Studies have found it effectively prevents the return of cytomegalovirus (CMV). Letermovir was well tolerated and helped reduce CMV-related issues in transplant patients.
Other research found that extended use of letermovir did not increase side effects and remained safe for patients. Overall, evidence suggests that letermovir is safe and well-tolerated for preventing CMV recurrence.12345Why do researchers think this study treatment might be promising?
Letermovir is unique because it focuses on preventing infections specifically in blood cancer patients receiving alemtuzumab, an immune-suppressing drug. Unlike standard antiviral treatments that target a wide range of viruses, letermovir specifically inhibits the replication of cytomegalovirus (CMV), a common and potentially severe threat to these patients. Researchers are excited about letermovir given its targeted mechanism of action and its potential to reduce infection rates without adding significant toxicity, which is a critical concern for patients with compromised immune systems.
What evidence suggests that letermovir might be an effective treatment for preventing cytomegalovirus reactivation in blood cancer patients?
Research has shown that letermovir, which participants in this trial will receive, effectively prevents the return of cytomegalovirus (CMV), a common virus. Studies have found that it significantly reduces CMV infections in patients who have had stem cell transplants. In one study, only 17% of patients taking letermovir experienced CMV reactivation, compared to 42% who did not take it. Letermovir is also well-tolerated, meaning most patients do not experience severe side effects. This evidence suggests that letermovir could be a strong option for preventing CMV infections in people with blood cancers who are receiving alemtuzumab.46789
Who Is on the Research Team?
John C Reneau, MD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are monitored for progression free survival and overall survival
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
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:
- 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?
Ohio State University Comprehensive 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
Citations
Efficacy and safety of letermovir prophylaxis for ...
Our systemic review and meta-analysis suggested that letermovir prophylaxis was safe and effective for CMV activation after allo-HSCT.
Real-Life Data on the Efficacy and Safety of Letermovir for ...
LMV prophylaxis was effective in preventing CMV reactivation with a favorable safety profile. CMV reactivation occurred mostly after LMV ...
Articles Efficacy and safety of extended duration letermovir ...
The results of a large, global, phase 3 study (the P001 study) showed that letermovir was well tolerated and superior to placebo in reducing the incidence of ...
Letermovir prophylaxis for cytomegalovirus is associated…
In both cohorts, letermovir significantly reduced clinically significant CMV infection and refractory CMV infection within 180 days after the ...
Benefits of primary prophylaxis with letermovir in patients ...
Twelve patients (17%) and 71 (42%) reactivated CMV in LMV-treated and LMV-free patients, respectively. The cumulative incidence of cs-CMVi was lower in LMV ...
Real-World Outcomes Associated With Letermovir Use for ...
Letermovir for CMV PP was effective in reducing the risk of CMV-related complications overall and mortality beyond day 200 among adult allo-HCT recipients.
Real-Life Data on the Efficacy and Safety of Letermovir for ...
LMV prophylaxis was effective in preventing CMV reactivation with a favorable safety profile. CMV reactivation occurred mostly after LMV ...
Efficacy and safety of extended duration letermovir ...
Extending the duration of letermovir prophylaxis to 200 days following HSCT is efficacious and safe in reducing the incidence of late clinically ...
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journals.lww.com
journals.lww.com/bls/fulltext/2024/01000/efficacy_and_safety_of_letermovir_prophylaxis_for.2.aspxEfficacy and safety of letermovir prophylaxis for...
Our systemic review and meta-analysis suggested that letermovir prophylaxis was safe and effective for CMV activation after allo-HSCT.
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