Cytomegalovirus Cell Mediated ImmunityNCT06639854
The Use of Cytomegalovirus Cell Mediated Immunity to Optimize the Duration of Letermovir Prophylaxis in Hematopoietic Cell Transplant Recipients
A study testing Hematopoietic Cell Transplant and Letermovir in people with Cytomegalovirus Cell Mediated Immunity and Hematopoietic Cell Transplant, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Cell Mediated Immunity, Hematopoietic Cell Transplant
- What is being tested?
- Hematopoietic Cell Transplant and Letermovir
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 recipients)
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Fareed Khawaja, MBBS, 281-610-0253, fkhawaja@mdanderson.org
Fareed Khawaja, MBBS
About this study
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.
Read the 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.
- Being tested
- Hematopoietic Cell Transplant, Letermovir
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hematopoietic Cell TransplantProcedure or surgery
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.
LetermovirDrug
Given by PO
| Study group | Role | What they receive |
|---|---|---|
| Interrupted letermovir prophylaxis | Experimental | Participants assigned to the investigational group, you will also receive letermovir at first, but depending on the result of the study blood tests, your dose may be paused as long as your immune system shows an immune response against CMV. Receives: Procedure: Hematopoietic Cell Transplant; Drug: Letermovir |
| Standard letermovir prophylaxis | Experimental | Participants assigned to the standard care group, you will receive treatment with letermovir every day to prevent CMV infection. Receives: Procedure: Hematopoietic Cell Transplant; Drug: Letermovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Adverse Events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start20 Nov 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus Cell Mediated ImmunityStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fareed Khawaja, MBBS, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06639854
- Sponsor's protocol ID
- 2024-1144
- Other IDs
- NCI-2024-08626
- Status last verified
- Jun 2026
- First submitted
- 10 Oct 2024
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- Acronym / sponsor ID
- 2024-1144
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interrupted letermovir prophylaxis | Experimental | Procedure: Hematopoietic Cell Transplant, Drug: LetermovirParticipants assigned to the investigational group, you will also receive letermovir at first, but depending on the result of the study blood tests, your dose may be paused as long as your immune system shows an immune response against CMV. |
| Standard letermovir prophylaxis | Experimental | Procedure: Hematopoietic Cell Transplant, Drug: LetermovirParticipants assigned to the standard care group, you will receive treatment with letermovir every day to prevent CMV infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hematopoietic Cell TransplantParticipants 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. | Procedure or surgery | Interrupted letermovir prophylaxis, Standard letermovir prophylaxis |
| LetermovirGiven by PO | Drug | Interrupted letermovir prophylaxis, Standard letermovir prophylaxis |
Primary outcome
Safety and Adverse Events (AEs).
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
Related trials for Cytomegalovirus Cell Mediated Immunity
Not yet recruitingObservational study
Impact of CMV-Specific Immune Reconstitution at the End of Letermovir Prophylaxis on the Development of Late Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Recipients (INMUNOEND)
Cytomegalovirus Cell Mediated Immunity, Stem Cell Transplantation, Hematopoietic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fareed Khawaja, MBBS principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hematopoietic Cell Transplant and Letermovir in people with Cytomegalovirus Cell Mediated Immunity and Hematopoietic Cell Transplant, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fareed Khawaja, MBBS ((281) 610-0253, fkhawaja@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Adverse Events (AEs). (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.