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New treatment option for Cytomegalovirus Cell Mediated Immunity
Official title The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
ClinicalTrials.gov ID: NCT06639854
What this study is testing
What is Letermovir?
Letermovir is an investigational medicine, being studied as a potential treatment for cytomegalovirus cell mediated immunity.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this laboratory research study is to learn if interrupting a patient's letermovir dosing based on their immune system response can help HSC transplant patients avoid post-treatment CMV infections better than taking letermovir every day without interruption.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Allogeneic HCT recipients with positive CMV serostatus
- On letermovir prophylaxis at day 90 post transplant (+/- 7 days)
- At high risk for CMV reactivation after day +100:
- Prior or active graft versus host disease requiring systemic steroids
- Mismatch stem cell donor (includes haploidentical, mismatch unrelated donor (MMUD), match related donor with at least one mismatch at one of the...
You likely can't join if
- Patients under the age of 18
- Patients are discharged from our institution and unwilling to come back for follow up
- Patients are actively undergoing treatment for CS-CMVi at time of screening. Prior CS-CMVi is not an exclusion from study.
- Patients are allergic or intolerant to letermovir or have history of letermovir resistant CMV infection.
- Not able to procure letermovir for extended prophylaxis beyond day +100.
See the full eligibility criteria
- Allogeneic HCT recipients with positive CMV serostatus
- On letermovir prophylaxis at day 90 post transplant (+/- 7 days)
- At high risk for CMV reactivation after day +100:
- Prior or active graft versus host disease requiring systemic steroids
- Mismatch stem cell donor (includes haploidentical, mismatch unrelated donor (MMUD), match related donor with at least one mismatch at one of the three specified HLA gene loci (HLA-A, HLA-B, or HLA-DR) and cord donor...
- Received T cell depletion or anti thymoglobulin during conditioning
- CMV reactivation prior to day 100 post transplant
- On steroids at any dose within 2 weeks of enrollment
- Patients under the age of 18
- Patients are discharged from our institution and unwilling to come back for follow up
- Patients are actively undergoing treatment for CS-CMVi at time of screening. Prior CS-CMVi is not an exclusion from study.
- Patients are allergic or intolerant to letermovir or have history of letermovir resistant CMV infection.
- Not able to procure letermovir for extended prophylaxis beyond day +100.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.