Cytomegalovirus Cell Mediated Immunity, Hematopoietic Cell Transplant
Conditions
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.
Detailed description
Primary Objective •To compare the proportion of CS-CMVi in allo-HCT recipients who had interrupted letermovir prophylaxis based on CMV CMI or extended duration of letermovir prophylaxis up to 200 days post transplantation. Secondary Objectives * To compare the proportion of CS-CMVi in HCT recipients who had interrupted letermovir prophylaxis based on CMV CMI or extended duration of letermovir prophylaxis at 365 days post transplantation. * To compare the overall use of letermovir in HCT recipients in both arms. * To compare CMV CMI in HCT recipients in both arms. * To compare all-cause mortality and nonrelapse mortality between the 2 arms at day +200 and day +365. * Healthcare expenditures for letermovir use and TCIP for both arms from day +100 to day +200.
Interventions
PROCEDUREHematopoietic Cell Transplant
Participants choices may include to receive standard post-transplant virus prevention with letermovir or other standard drugs without being part of this study. Participants may choose to receive other investigational therapy, if available. These alternative treatments have risks and benefits that may be the same or different than those in this research study.
DRUGLetermovir
Given by PO
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs). | Through study completion; an average of 1 year. | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
CONTACTFareed Khawaja, MBBS
PRINCIPAL_INVESTIGATORFareed Khawaja, MBBS
M.D. Anderson Cancer Center
Outcome results
None listed