A Study of the Drug Letermovir (LTV) as Prevention for Recurrent of Cytomegalovirus (CMV) Infection

  • STATUS
    Recruiting
  • End date
    Jul 25, 2023
  • participants needed
    86
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 25 March 2022
hla-a
prednisone
ganciclovir
valganciclovir
foscarnet
dhpg
viremia
letermovir

Summary

The purpose of this study is to determine of letermovir (LTC) is effective at preventing Cytomegalovirus (CMV) infection from returning in people who have already had CMV infection after a bone marrow transplant.

Details
Condition CMV, CMV Infection, Hematopoietic Cell Transplant
Treatment Blood draw, Letermovir Pill
Clinical Study IdentifierNCT04017962
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age >/= 12 years (any weight)
Have received allogenic HCT
Have received preemptive therapy for clinically significant CMV infection post-HCT and have completed preemptive therapy no longer than 7 days prior to enrollment. Preemptive treatment includes ganciclovir, valganciclovir, foscarnet or cidofovir. Clinically significant CMV infection is defined as CMV viremia requiring preemptive therapy or CMV EOD. Patients who have received LTV prophylaxis prior to onset of clinically significant CMV infection prior to enrollment (see also exclusion criteria below)
Have one or more risk factors for recurrent CMV infection
Human leukocyte antigen (HLA) mismatch
HLA-related (sibling) donor with at least one mismatch at the HLA-A, -B or -DR gene loci
Haploidentical donor
Unrelated donor with at least one mismatch at the HLA-A, -B, -C or -DRC1gene loci, or
Cord blood as stem cell source
Acute or chronic GVHD requiring either topical steroids for gastrointestinal GVHD
Willing and able to comply with trial instructions and requirements
and/or systemic steroid treatment (>/= 1mg/kg/day of prednisone or equivalent
dose of another corticosteroid) within 14 days prior to enrollment
Male and female patients of childbearing potential must be willing to use a highly effective method of contraception for the course of the study. Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient
T-cell-depleted allograft ex-vivo or in-vivo T-cell depleting agents including but not limited to ATG, alemtuzimab and post HCT cyclophosphamide
Subject eligibility criteria for the observational cohort
For adult patients, able to provide written consent and complete the informed consent
Age 18 years or older
First allogenic peripheral blood or marrow HCT
For patients under 18 years, the patient's parent(s) or legal guardian(s) must
LTV prophylaxis starting <30 days post HCT and given for at least 6 weeks
provide informed consent and the patient must provide written assent to
participation in the study
T-cell count >/=100 at day +100

Exclusion Criteria

Clinically significant CMV infection present at enrollment
Glomerular filtration rate (GFR) </= mL/min/1.73m^2(equivalent to creatinine clearance </=10 mL/min)
Routine use of high-dose acyclovir (doses of > 800 mg twice daily), valacyclovir (doses of > 500mg twice daily), or famciclovir (doses > 500mg/day) for varicella zoster virus (VZV)/herpes simplex virus prophylaxis; limited treatment courses at higher doses for VZV infections are permissible if treatment duration dose not exceed 14 days total. Short courses of IV cidofovir for adeno virus (ADV) are permissible
Suspected or known hypersensitivity to active or inactive ingredients of LTV formulations
Patients treated with a medication whose administration with LTV is ontraindicated and whose discontinuation is not possible. Contraindicated medications include pimozide, ergot alkaloids and pitavastatin or simvastatin when co-administered with cyclosporine
Imminent demise (expected survival <6 weeks)
Breakthrough CMV infection while on primary LTV prophylaxis (unless patient non-adherent or unable to adequately absorb letermovir or documented resistance to LTV
Documented positive result for human immunodeficiency virus antibody (HIV-Ab) or for hepatitis C virus antibody (HCV-Ab) with detectable HCV RNA, or hepatitis B surface antigen (HBsAg) at any time prior to HCT
Need for mechanical ventilation and/or vasopressor support at the time of enrollment
Severe hepatic impairment
Pregnancy or breastfeeding
Plans to conceive or father children within the projected duration of the trial
History of current evidence of any condition, therapy, lab abnormality, or other circumstance that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or would place the subject at undue risk as judged by the investigator, such that it is not in the best interest of the subject to participate in this study
Exclusion criteria for observational cohort
Clinically significant CMV infection during the 100 days following HCT. Clinically significant CMV infection defined as either CMV viremia requiring preemptive therapy with CMV antivirals or CMV end organ disease (EOD)
Grade 3-4 GVHD
Cord blood as cell source for HCT
The following antivirals are allowed up to the listed dose limits
Acyclovir up to 800 mg twice daily
Valacyclovir up to 500 mg twice daily
Famciclovir up to 500 mg/day for VZV/HSV prophylaxis; limited treatment courses at higher doses for VZV infections are permissible if treatment duration does not exceed 14 days total
Short courses of IV cidofovir for ADV (up to two doses)
Treatment with systemic steroids (>0.5mg/kg for 2 weeks or longer) within 3 weeks prior to enrollment
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