NCT06639854 The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
| NCT ID | NCT06639854 |
| Status | Recruiting |
| Phase | — |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Cytomegalovirus Cell Mediated Immunity |
| Study Type | INTERVENTIONAL |
| Enrollment | 105 participants |
| Start Date | 2024-11-20 |
| Primary Completion | 2027-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 105 participants in total. It began in 2024-11-20 with a primary completion date of 2027-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion criteria 1. Allogeneic HCT recipients with positive CMV serostatus 2. On letermovir prophylaxis at day 90 post transplant (+/- 7 days) 3. At high risk for CMV reactivation after day +100: 1. Prior or active graft versus host disease requiring systemic steroids 2. 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 recipients) 3. Received T cell depletion or anti thymoglobulin during conditioning 4. CMV reactivation prior to day 100 post transplant 5. On steroids at any dose within 2 weeks of enrollment Exclusion criteria 1. Patients under the age of 18 2. Patients are discharged from our institution and unwilling to come back for follow up 3. Patients are actively undergoing treatment for CS-CMVi at time of screening. Prior CS-CMVi is not an exclusion from study. 4. Patients are allergic or intolerant to letermovir or have history of letermovir resistant CMV infection. 5. Not able to procure letermovir for extended prophylaxis beyond day +100.
Contact & Investigator
Fareed Khawaja, MBBS
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06639854 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cytomegalovirus Cell Mediated Immunity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06639854 currently recruiting?
Yes, NCT06639854 is actively recruiting participants. Contact the research team at fkhawaja@mdanderson.org for enrollment information.
Where is the NCT06639854 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06639854 clinical trial?
NCT06639854 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Fareed Khawaja, MBBS at M.D. Anderson Cancer Center. The trial plans to enroll 105 participants.