Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Mali… (NCT04312841) | Clinical Trial Compass
CompletedPhase 2
Letermovir for the Prevention of Cytomegalovirus Reactivation in Patients With Hematological Malignancies Treated With Alemtuzumab
United States6 participantsStarted 2020-09-15
Plain-language summary
This phase II trial studies how well letermovir works for the prevention of cytomegalovirus reactivation in patients with hematological malignancies treated with alemtuzumab. Patients receiving treatment with alemtuzumab may experience cytomegalovirus reactivation. Letermovir may block cytomegalovirus replication and prevent infection.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Confirmed diagnosis of T-cell or B-cell prolymphocytic leukemia, chronic lymphocytic leukemia, peripheral T-cell lymphoma, cutaneous T-cell lymphoma, or Sezary syndrome
* Intent to treat with alemtuzumab. Monotherapy or combination with chemotherapy is allowed
* Confirmed seropositivity for CMV IgG (\>= 0.7 U/mL) within 1 year of first letermovir dose
* Confirmed lack of active CMV infection as evidenced by:
* Undetectable CMV deoxyribonucleic acid (DNA) by Abbott RealTime CMV in vitro polymerase chain reaction assay (\< 50 IU/mL) within 7 days of first letermovir dose AND
* Negative CMV IgM (\< 30 AU/mL) within 7 days of first letermovir dose
* Able to provide informed consent
* Life expectancy \> 4 months
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
* Highly unlikely to become pregnant or impregnate a partner by meeting at least one of the following:
* A female subject who is not of reproductive potential is eligible without requiring the use of contraception. A female subject who is not of reproductive potential is defined as one who:
* Has reached natural menopause (defined as 6 months of spontaneous amenorrhea with serum follicle-stimulating hormone \[FSH\] levels in the postmenopausal range as determined by the local laboratory, or 12 months of spontaneous amenorrhea) OR
* Is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy OR
* Has undergone bilateral tubal ligation. Spontaneou…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cytomegalovirus (CMV) Reactivation
Timeframe: During prophylaxis treatment (3 months after last dose of alemtuzumab)
Trial details
NCT IDNCT04312841
SponsorOhio State University Comprehensive Cancer Center