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Virus Therapy
Letermovir for Preventing CMV Infection After Bone Marrow Transplant
Phase 2
Waitlist Available
Led By Genovefa Papanicolaou
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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).
- Cord blood as stem cell source
Must not have
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.
Need for mechanical ventilation and/or vasopressor support at the time of enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial will test if LTC can prevent CMV infection from returning in people who have already had it after a bone marrow transplant.
Who is the study for?
This trial is for individuals aged 12 or older who have had a bone marrow transplant, received treatment for CMV infection post-transplant, and are at risk of the infection returning. They must be able to consent (or have a guardian consent), follow trial procedures, and use effective contraception if applicable. People with severe kidney or liver issues, certain drug interactions, HIV/HCV/HBsAg positivity, need for intensive care support, pregnancy/breastfeeding intentions during the trial period cannot join.
What is being tested?
The study tests whether Letermovir pills can prevent the recurrence of Cytomegalovirus (CMV) infection in patients who've previously been treated for CMV after receiving a bone marrow transplant. Participants will take Letermovir and undergo regular blood draws to monitor their health.
What are the potential side effects?
Possible side effects of Letermovir include headaches, nausea, vomiting, diarrhea; less commonly it may affect liver enzymes or cause anemia. Allergic reactions are rare but possible in those sensitive to the medication's components.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've completed treatment for a serious CMV infection within the last 7 days.
Select...
My stem cell treatment will use cord blood.
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I have received a T-cell-depleted transplant or agents like ATG, alemtuzumab, or cyclophosphamide after transplant.
Select...
My donor has at least one HLA gene mismatch.
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I am 12 years old or older.
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I have received a stem cell transplant from a donor.
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My donor and I have different HLA types.
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My bone marrow donor is a sibling with at least one HLA gene mismatch.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am taking a medication that cannot be stopped and is not safe with LTV.
Select...
I need a machine to help me breathe or medication to support my blood pressure.
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I have severe liver problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2022 Phase 3 trial • 22 Patients • NCT0412939818%
Stomatitis
14%
Diarrhoea
14%
Hyperlipidaemia
14%
Neutrophil count decreased
9%
Nausea
9%
Insomnia
9%
Anaemia
9%
Leukopenia
9%
Urinary tract infection
9%
Haematuria
9%
Incisional hernia
5%
Tonsillitis
5%
Complications of transplanted kidney
5%
Constipation
5%
Adenoviral haemorrhagic cystitis
5%
Herpes zoster
5%
Pneumocystis jirovecii pneumonia
5%
Lymphocele
100%
80%
60%
40%
20%
0%
Study treatment Arm
Letermovir
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Hematopoietic cell transplantation/HCTExperimental Treatment2 Interventions
Participants will be hematopoietic cell transplantation (HCT) recipients with a history of CMV infection. INTERVENTIONAL COHORT: Patients receive letermovir PO QD (or IV over 1 hour for patients unable to receive PO) for 14 weeks in the absence of disease progression or unacceptable toxicity.
OBSERVATIONAL COHORT: Patients undergo collection of blood samples for CMV-CMI analysis via CMV immunity T cell panel assay on day 100. Patients with negative CMI on day 100 undergo collection of blood samples for retesting on day 180.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,964 Previous Clinical Trials
596,824 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,986 Previous Clinical Trials
5,178,757 Total Patients Enrolled
Genovefa PapanicolaouPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received up to two doses of IV cidofovir for ADV.I use high-dose antiviral medication regularly, but only short treatments for severe infections.I am taking acyclovir, up to 800 mg twice daily.I am taking antivirals within the allowed dose limits.I am taking a medication that cannot be stopped and is not safe with LTV.I've completed treatment for a serious CMV infection within the last 7 days.I am taking Famciclovir up to 500 mg/day for virus prevention, or I have taken higher doses for short-term treatment.I am taking Valacyclovir, up to 500 mg twice daily.I can give my consent, or if under 18, my guardian can and I agree to participate.My stem cell treatment will use cord blood.I have received a T-cell-depleted transplant or agents like ATG, alemtuzumab, or cyclophosphamide after transplant.I have GVHD and have been treated with steroids recently.You must have a donor who is a close genetic match to you.I need a machine to help me breathe or medication to support my blood pressure.My donor has at least one HLA gene mismatch.I had a CMV infection despite being on LTV unless I couldn't take or absorb LTV, or it was resistant.You are expected to live less than 6 weeks.I am willing to use effective birth control or practice abstinence during the study.I am 12 years old or older.I have received a stem cell transplant from a donor.My donor and I have different HLA types.My bone marrow donor is a sibling with at least one HLA gene mismatch.I have severe liver problems.You have a suspected or confirmed allergy to the ingredients in the LTV medication.You have one or more factors that increase your risk of getting infected with CMV again.
Research Study Groups:
This trial has the following groups:- Group 1: Hematopoietic cell transplantation/HCT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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