← Back to Search

Antiviral

Letermovir for Preventing Infection After Stem Cell Transplant in Blood Cancer

Phase 3
Recruiting
Led By Caitlin W Elgarten
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age >= 2 years and < 18 years at the time of enrollment
Weight must be >= 18 kg. For patients < 12 years of age and expected to receive cyclosporine, weight must be >= 30kg
Must not have
Expected inability to tolerate oral formulation of letermovir
Female patients who are pregnant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to one-year post-transplant
Awards & highlights

Summary

"This trial aims to see if giving letermovir before stem cell transplant can help reduce the chances of getting a virus called cytomegalovirus in children and teenagers. The treatments before a stem

Who is the study for?
This trial is for children and teens (2-18 years old) who weigh at least 18 kg, are CMV sero-positive, and are planning to have a stem cell transplant. They must be healthy enough for the procedure (Lansky/Karnofsky scores > 50), not need dialysis, and have acceptable liver function tests.
What is being tested?
The study is testing if Letermovir can prevent cytomegalovirus infection in pediatric patients after a stem cell transplant. The drug aims to stop the virus from multiplying, potentially preventing or lessening the severity of infections.
What are the potential side effects?
Possible side effects of Letermovir include gastrointestinal symptoms like nausea and vomiting, potential liver enzyme elevation, headaches, coughing, fatigue, and an increased risk of other infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 2 and 17 years old.
Select...
I weigh at least 18 kg. If under 12 and taking cyclosporine, I weigh at least 30 kg.
Select...
I am scheduled for a stem cell transplant from a donor.
Select...
I can do most activities but may need help.
Select...
My kidneys work well enough and I'm not on dialysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot take letermovir by mouth.
Select...
I am currently pregnant.
Select...
I am a woman who can have children and I do not use birth control.
Select...
I received a stem cell transplant from a donor within the last year.
Select...
I am not planning to take any medications that are not allowed during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to one-year post-transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to one-year post-transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinically significant cytomegalovirus (CMV) infection
Secondary outcome measures
CMV-free survival
Detection of CMV DNAemia
Other outcome measures
CD4+ lymphocyte count
CD8+ lymphocyte count
CD8+ lymphocyte counts
+10 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: ARM I (Letermovir prophylaxis)Experimental Treatment2 Interventions
Patients receive letermovir PO or IV over 60 minutes QD starting on day +1 post-transplant for 14 weeks. Patients undergo collection of blood samples for CMV PCR analysis weekly for 14 weeks, every 2 weeks until week 24, week 32, week 40 and week 52.
Group II: ARM II (No prophylaxis)Active Control1 Intervention
Patients undergo collection of blood samples for CMV PCR analysis weekly for 14 weeks, every 2 weeks until week 24, week 32, week 40 and week 52.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Letermovir
2019
Completed Phase 3
~1530

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,687 Total Patients Enrolled
Caitlin W ElgartenPrincipal InvestigatorChildren's Oncology Group
~95 spots leftby Jun 2028
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top