← Back to Search

Virus Therapy

Letermovir for Preventing CMV Infection After Bone Marrow Transplant

Phase 2
Recruiting
Led By Genovefa Papanicolaou
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Have received preemptive therapy for clinically significant CMV infection post-HCT and have completed preemptive therapy no longer than 7 days prior to enrollment. Preemptive treatment includes ganciclovir, valganciclovir, foscarnet or cidofovir. Clinically significant CMV infection is defined as CMV viremia requiring preemptive therapy or CMV EOD. Patients who have received LTV prophylaxis prior to onset of clinically significant CMV infection prior to enrollment (see also exclusion criteria below).
- Cord blood as stem cell source
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks from time of study treatment
Awards & highlights

Study Summary

This trial will test if LTC can prevent CMV infection from returning in people who have already had it after a bone marrow transplant.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects of Letermovir include headaches, nausea, vomiting, diarrhea; less commonly it may affect liver enzymes or cause anemia. Allergic reactions are rare but possible in those sensitive to the medication's components.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I've completed treatment for a serious CMV infection within the last 7 days.
Select...
My stem cell treatment will use cord blood.
Select...
I have received a T-cell-depleted transplant or agents like ATG, alemtuzumab, or cyclophosphamide after transplant.
Select...
My donor has at least one HLA gene mismatch.
Select...
I am 12 years old or older.
Select...
I have received a stem cell transplant from a donor.
Select...
My donor and I have different HLA types.
Select...
My bone marrow donor is a sibling with at least one HLA gene mismatch.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks from time of study treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks from time of study treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The rate of breakthrough clinically significant Cytomegalovirus (CMV) infection by week 14

Side effects data

From 2022 Phase 3 trial • 22 Patients • NCT04129398
18%
Stomatitis
14%
Neutrophil count decreased
14%
Diarrhoea
14%
Hyperlipidaemia
9%
Nausea
9%
Incisional hernia
9%
Leukopenia
9%
Anaemia
9%
Urinary tract infection
9%
Insomnia
9%
Haematuria
5%
Herpes zoster
5%
Adenoviral haemorrhagic cystitis
5%
Pneumocystis jirovecii pneumonia
5%
Tonsillitis
5%
Complications of transplanted kidney
5%
Constipation
5%
Lymphocele
100%
80%
60%
40%
20%
0%
Study treatment Arm
Letermovir

Trial Design

1Treatment groups
Experimental Treatment
Group I: Hematopoietic cell transplantation/HCTExperimental Treatment2 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.

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,936 Previous Clinical Trials
588,775 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,060,565 Total Patients Enrolled
Genovefa PapanicolaouPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Letermovir (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04017962 — Phase 2
Cytomegalovirus Research Study Groups: Hematopoietic cell transplantation/HCT
Cytomegalovirus Clinical Trial 2023: Letermovir Highlights & Side Effects. Trial Name: NCT04017962 — Phase 2
Letermovir (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04017962 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any ongoing recruitment for this investigation?

"Per clinicaltrials.gov, this trial is open for recruitment as of July 26th 2022; it was initially posted on 19/7/2019."

Answered by AI

What is the total participant count in this trial?

"Affirmative. Clinicaltrials.gov illustrates that this clinical trial is seeking enrollment, having been first posted on July 19th 2019 and recently updated on July 26 2022. This project requires 86 individuals among 2 healthcare facilities to be recruited for participation in the study."

Answered by AI

Has this clinical experiment been attempted before?

"The development of Letermovir Pill began in 2019, when Merck Sharp & Dohme LLC sponsored the first study. After gaining Phase 2 approval from this initial trial involving 86 patients, 7 additional studies have been launched globally across 34 cities and 11 nations."

Answered by AI

Are there previous research endeavors that explore the efficacy of Letermovir Pill?

"The University of Minnesota was the first to research letermovir pill in 2019, with 27 trials completed since. At present, 7 new clinical studies are being conducted; primarily centered around New york City."

Answered by AI

Has Letermovir Pill been granted authorization by the Food and Drug Administration?

"As Letermovir Pill is in the Phase 2 trial stage, there are findings that attest to its safety but no evidence confirming efficacy. Therefore, our team at Power assigned it a rating of 2 on the scale from 1 to 3."

Answered by AI

Who else is applying?

What state do they live in?
Minnesota
How old are they?
18 - 65
What site did they apply to?
University of Minnesota
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection
2019. "A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04017962.
All > Cmv
~4 spots leftby Jul 2024
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