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 range18 Years
SexALL
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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. Spontaneouā¦
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