BridgeMD
Prevention study for Hematopoietic and Lymphoid Cell Neoplasm
Official title A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients
ClinicalTrials.gov ID: NCT05711667
What this study is testing
What is Letermovir?
Letermovir is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for hematopoietic and lymphoid cell neoplasm.
Also referred to as 2-((4S)-8-Fluoro-2-(4-(3-methoxyphenyl)piperazin-1-yl)-3-(2-methoxy-5-(trifluoromethyl)phenyl)-4H-quinazolin-4-yl)acetic Acid, AIC246.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III single arm trial determines whether taking prophylactic letermovir will reduce the likelihood of infection with cytomegalovirus (CMV) in children and adolescents after stem cell transplant compared to estimated rate of infection without prophylaxis. The treatments used to prepare for HCT reduce the body's natural infection-fighting ability and increase the likelihood of an infection with a virus called cytomegalovirus.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- \>= 2 years and \< 18 years at the time of enrollment
- Weight must be \>= 6 kg at the time of enrollment
- Planned allogeneic HCT (bone marrow, peripheral blood stem cell, or cord blood transplant)
- Patient must be CMV sero-positive (i.e., recipient CMV immunoglobulin G positive)
- Note: If a patient has hypogammaglobulinemia but has previously been documented as CMV sero-positive, that is acceptable for study inclusion. For all...
You likely can't join if
- Expected inability to tolerate oral formulation of letermovir
- Hypersensitivity to letermovir or any component of the formulation
- History of CMV end organ disease within 6 months (180 days) prior to enrollment
- Note: CMV end organ disease based on proposed definitions by Ljungman et al. and inclusive of proven, probable or possible disease
- Receipt of prior allogeneic HCT within one year of study enrollment
- Planned prophylactic administration of other anti-CMV medications or cellular products during the study, including:
See the full eligibility criteria
- \>= 2 years and \< 18 years at the time of enrollment
- Weight must be \>= 6 kg at the time of enrollment
- Planned allogeneic HCT (bone marrow, peripheral blood stem cell, or cord blood transplant)
- Patient must be CMV sero-positive (i.e., recipient CMV immunoglobulin G positive)
- Note: If a patient has hypogammaglobulinemia but has previously been documented as CMV sero-positive, that is acceptable for study inclusion. For all patients already confirmed to be CMV IgG seropositive, repeat testing...
- Patient is eligible for entry only if it is feasible for plasma CMV PCR testing to be sent and resulted within the protocol mandated time period
- Reminder: To limit the likelihood of positive plasma CMV PCR post-enrollment and prior to start of study treatment period, it is recommended that patient enrollment proceed after patients start their transplant...
- Patient must have a performance status corresponding to Lansky/Karnofsky scores \> 50
- Note: Use Lansky for patients =\ 16 years of age. For further reference, see performance status scales scoring under the standard sections for protocols among protocol reference materials provided on the Children's...
- Estimated glomerular filtration rate \> 10 mL/min/1.73 m\^2 and not receiving dialysis
- Direct bilirubin =\< 2 mg/dL and serum glutamate-pyruvate transaminase (SPGT) (alanine transaminase [ALT]) =\<10 x upper limit of normal (ULN) for age
- Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
- Expected inability to tolerate oral formulation of letermovir
- Hypersensitivity to letermovir or any component of the formulation
- History of CMV end organ disease within 6 months (180 days) prior to enrollment
- Note: CMV end organ disease based on proposed definitions by Ljungman et al. and inclusive of proven, probable or possible disease
- Receipt of prior allogeneic HCT within one year of study enrollment
- Planned prophylactic administration of other anti-CMV medications or cellular products during the study, including:
- High dose acyclovir (defined as doses \>= 1500 mg/m\^2 IV or \>= 3200 mg oral (patients \>= 40 kg) or \>= 2400 mg/m\^2 (patients \< 40 kg) per day)
- High dose valacyclovir (defined as doses \>= 3000 mg/day in patients \> 20 kg)
- Foscarnet
- Ganciclovir
- Valganciclovir
- CMV-directed cytotoxic T lymphocytes
- Planned receipt of the following contraindicated medications during the study treatment period; contraindicated medications must be discontinued at least 14 days prior to Day +1
- Contraindicated medications for all patients:
- Pimozide
- Ergot alkaloids
- Contraindicated medications for patients planned to receive cyclosporine:
- Bosentan
- Pitavastatin
- Simvastatin
- Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted in certain animal reproduction studies with letermovir. A pregnancy test is required for female patients of childbearing...
- Lactating females who plan to breastfeed their infants
- Sexually active female patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their letermovir treatment and through at least 4 weeks after the last dose of...
- Note: No contraception measures are needed specifically during letermovir treatment for male trial participants who have pregnant or non-pregnant female partner(s) of reproductive potential. Contraception measures may...
- All patients and/or their parents or legal guardians must sign a written informed consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Oakland, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Wilmington, Delaware, United States
- Jacksonville, Florida, United States
- Miami, Florida, United States
- Honolulu, Hawaii, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Louisville, Kentucky, United States
- New Orleans, Louisiana, United States
- Baltimore, Maryland, United States
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
- Kansas City, Missouri, United States
- St Louis, Missouri, United States
- Oklahoma City, Oklahoma, United States
- Philadelphia, Pennsylvania, United States
- Memphis, Tennessee, United States
+ 7 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Oakland, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Wilmington, Delaware, United States; Jacksonville, Florida, United States and 21 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.