BridgeMD
New treatment option for Cell Therapy
Official title Single Arm Pilot Trial of Letermovir for CMV Prophy in CAR T Cell
ClinicalTrials.gov ID: NCT06575374
What this study is testing
What is Letermovir?
Letermovir is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cell therapy.
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
- The goal of this clinical research study is to learn if a drug called Letermovir can help to prevent CMV reactivation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years of age.
- Have an ECOG performance status of 0 or 1.
- The participant must be scheduled for SOC AXI-CEL.
- The participant must be seropositive for CMV (defined as having anti-CMV IgG antibodies)
- Creatinine clearance \> 10 mL/min
You likely can't join if
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection not responding to treatment, symptomatic congestive...
- Female participants who are pregnant or breastfeeding.
- Unwilling or unable to follow protocol requirements.
- Planned to receive any other anti-CMV therapy such as high dose acyclovir (500 mg/m2/dose intravenously every 8 hours or 800 mg orally 4 times a day)...
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
- Evidence for CMV infection defined as any positive CMV DNA qPCR test within 1 week prior to starting letermovir.
See the full eligibility criteria
- Age ≥ 18 years of age.
- Have an ECOG performance status of 0 or 1.
- The participant must be scheduled for SOC AXI-CEL.
- The participant must be seropositive for CMV (defined as having anti-CMV IgG antibodies)
- Creatinine clearance \> 10 mL/min
- Child Pugh class A or B if liver disease is present.
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect...
- Participant must understand the investigational nature of this study and sign an Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection not responding to treatment, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or...
- Female participants who are pregnant or breastfeeding.
- Unwilling or unable to follow protocol requirements.
- Planned to receive any other anti-CMV therapy such as high dose acyclovir (500 mg/m2/dose intravenously every 8 hours or 800 mg orally 4 times a day) or high dose valacyclovir (2 grams three to four times daily or 2...
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
- Evidence for CMV infection defined as any positive CMV DNA qPCR test within 1 week prior to starting letermovir.
- Child Pugh class C liver disease.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.