Optimizing Letermovir Prophylaxis for Hematopoietic Cell Transplant Recipients
The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
This study is testing if stopping a medication for preventing CMV infections based on a patient's immune response can help hematopoietic cell transplant recipients stay healthier and avoid infections.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06639854 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to determine whether interrupting letermovir prophylaxis based on a patient's immune response can reduce the incidence of cytomegalovirus (CMV) infections in hematopoietic cell transplant (HCT) recipients. The study compares two approaches: one where letermovir is administered continuously and another where it is interrupted based on cytomegalovirus cell-mediated immunity (CMI) assessments. The trial will evaluate the effectiveness of these strategies in preventing CMV reactivation and their impact on overall health outcomes, including mortality rates and healthcare costs. Participants will be monitored for up to 365 days post-transplant to assess the long-term effects of the interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are allogeneic HCT recipients who are CMV positive and at high risk for CMV reactivation.
Not a fit: Patients under the age of 18 or those currently undergoing treatment for cytomegalovirus infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective prophylaxis strategies for preventing CMV infections in HCT recipients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in optimizing antiviral prophylaxis based on immune responses, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Fareed Khawaja, MBBS — M.D. Anderson Cancer Center
- Study coordinator: Fareed Khawaja, MBBS
- Email: fkhawaja@mdanderson.org
- Phone: (281) 610-0253
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.