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Virus Therapy
Letermovir for Preventing Infection in Blood Cancer Patients
Phase 2
Recruiting
Led By John C Reneau, MD
Research Sponsored by Ohio State University Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of T-cell or B-cell prolymphocytic leukemia, chronic lymphocytic leukemia, peripheral T-cell lymphoma, cutaneous T-cell lymphoma, or Sezary syndrome
Is 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial looks at whether letermovir can prevent cytomegalovirus reactivation in cancer patients being treated with alemtuzumab. Letermovir may help by blocking the virus from replicating and preventing infection.
Who is the study for?
This trial is for adults with certain blood cancers (like leukemia or lymphoma) who are being treated with alemtuzumab and have a risk of cytomegalovirus reactivation. They must not be pregnant, should agree to use birth control, and cannot have severe kidney or liver problems, recent CMV disease, HIV with low CD4 count, or be on conflicting medications.Check my eligibility
What is being tested?
The study tests if letermovir can prevent cytomegalovirus (CMV) infection in patients receiving alemtuzumab for blood cancers. It's a phase II trial where the effectiveness of letermovir as a preventive measure against CMV reactivation is being evaluated.See study design
What are the potential side effects?
Letermovir may cause side effects like headaches, nausea, vomiting, diarrhea, coughing and potential allergic reactions. Since it targets virus replication specifically, it generally has fewer impacts on blood counts compared to other antiviral drugs.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a specific type of leukemia or lymphoma.
Select...
It has been 6 weeks since my surgery to remove both ovaries, with or without uterus removal.
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I am capable of only limited self-care, confined to a bed or chair more than 50% of waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cytomegalovirus (CMV) reactivation
Secondary outcome measures
Development of CMV disease
Incidence of adverse events
Overall survival (OS)
+1 moreOther outcome measures
Cytomegalovirus Infections
Side effects data
From 2016 Phase 3 trial • 570 Patients • NCT0213777239%
Graft versus host disease
29%
Diarrhoea
28%
Nausea
24%
Rash
23%
Pyrexia
21%
Vomiting
17%
Cough
16%
Oedema peripheral
16%
Headache
15%
Cytomegalovirus infection
15%
Fatigue
13%
Abdominal pain
12%
Mucosal inflammation
12%
Decreased appetite
10%
Blood creatinine increased
10%
Dyspnoea
9%
Hypertension
9%
Acute kidney injury
9%
Oropharyngeal pain
9%
Insomnia
9%
Erythema
8%
Hyperkalaemia
8%
Febrile neutropenia
8%
Asthenia
8%
Hyperglycaemia
8%
Constipation
8%
Arthralgia
8%
Dizziness
8%
Tremor
8%
Dry skin
8%
Pruritus
7%
Alanine aminotransferase increased
7%
Epistaxis
7%
Thrombocytopenia
6%
Dyspepsia
6%
Stomatitis
6%
Bacteraemia
6%
Aspartate aminotransferase increased
6%
Acute myeloid leukaemia recurrent
6%
Anaemia
6%
Dry eye
6%
Abdominal pain upper
6%
Dry mouth
6%
Hypokalaemia
6%
Hypomagnesaemia
6%
Hyponatraemia
6%
Back pain
6%
Myalgia
6%
Anxiety
5%
Nasopharyngitis
5%
Dysuria
5%
Neutropenia
5%
Chest pain
5%
Pain in extremity
5%
Dysgeusia
4%
Hypotension
4%
Pneumonia
4%
Rhinorrhoea
3%
Viraemia
3%
Muscle spasms
2%
Gastrooesophageal reflux disease
2%
Acute lymphocytic leukaemia recurrent
2%
Respiratory failure
2%
Sepsis
2%
Acute myeloid leukaemia
1%
Gastrointestinal haemorrhage
1%
Squamous cell carcinoma
1%
Hepatic function abnormal
1%
Pneumonia bacterial
1%
Staphylococcal bacteraemia
1%
Viral haemorrhagic cystitis
1%
Gastroenteritis
1%
Urinary tract infection
1%
Multiple organ dysfunction syndrome
1%
Sinusitis
1%
Pneumothorax
1%
Venoocclusive liver disease
1%
Plasma cell myeloma recurrent
1%
Herpes zoster
1%
Pleural effusion
1%
Pancytopenia
1%
Bronchopulmonary aspergillosis
1%
Cellulitis
1%
Clostridium difficile colitis
1%
Transplant failure
1%
Myelodysplastic syndrome
1%
Epstein-Barr virus infection
1%
Gastroenteritis viral
1%
Rhinovirus infection
1%
Septic shock
1%
Neurotoxicity
1%
Acute lymphocytic leukaemia
1%
Mantle cell lymphoma
1%
Sciatica
1%
Syncope
1%
Cystitis haemorrhagic
1%
Acute respiratory distress syndrome
1%
Venoocclusive disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Letermovir
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (letermovir)Experimental Treatment1 Intervention
Beginning within 7 days of the first administration of standard alemtuzumab, patients receive letermovir PO (or IV over 1 hour if patient is unable to take PO for an extended period of time) daily on days 1-28. Cycles repeat every 28 days for up to 3 months after the last dose of alemtuzumab in the absence of unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letermovir
FDA approved
Find a Location
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,142 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,892 Previous Clinical Trials
5,061,121 Total Patients Enrolled
John C Reneau, MDPrincipal InvestigatorOhio State University Comprehensive Cancer Center
1 Previous Clinical Trials
12 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking or have taken Ganciclovir.I have received CMV hyper-immune globulin.I am not taking Pimozide.I have been diagnosed with a specific type of leukemia or lymphoma.My kidneys are in end stage disease with very low filtration.I have moderate liver and kidney problems.I take more than 20 mg of Atorvastatin daily.I am a woman who cannot become pregnant.My liver function is severely impaired.I haven't taken certain drugs in the last 7 days and won't during the study.My CMV virus test shows undetectable levels recently.You are expected to live for at least 4 more months.You have a known allergy or sensitivity to any of the ingredients in the letermovir medication.I am using reliable birth control methods or my partner is sterile.I am taking Cyclosporine A.I am a man who cannot father a child.My kidney function is reduced, with a creatinine clearance under 50 mL/min.I am taking high doses of Acyclovir.I am currently taking or have taken Foscarnet.I am not taking any medications related to ergot alkaloids.I am currently taking or have taken Cidofovir.I haven't taken certain medications or treatments in the last 30 days.I had a confirmed CMV infection within the last year.I have had a stem cell transplant from a donor.My low blood cell counts do not disqualify me from this trial.I am taking more than 1500 mg of Famciclovir daily.It has been 6 weeks since my surgery to remove both ovaries, with or without uterus removal.I have not used experimental CMV treatments.I have Hepatitis C but haven't had or am currently on effective antiviral treatment with undetectable virus levels.You have previously taken part in a study involving letermovir.I have gone through natural menopause.I agree to use effective birth control or practice true abstinence during and for 90 days after the study.I have hepatitis B with a detectable viral load or will be monitored for it.I am not on any medications that are not allowed in the study due to an infection or disease.I am HIV positive with a CD4 count below 350 and on stable antiretroviral therapy.I am capable of only limited self-care, confined to a bed or chair more than 50% of waking hours.I have had both of my fallopian tubes surgically closed.My liver function is moderately impaired.I am taking Valganciclovir.I plan to be treated with alemtuzumab, alone or with chemotherapy.I understand and can agree to the study's procedures and risks.I am taking more than 3000 mg of Valacyclovir daily.You had a vasectomy more than 2 years ago but have not gotten anyone pregnant despite having sex since then.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (letermovir)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Letermovir been tested in prior experiments?
"Currently, 7 clinical trials of Letermovir are underway; none have advanced to the Phase 3 stage yet. The majority of these research projects take place in Columbus, Ohio, although 67 different trial sites exist across the country."
Answered by AI
How many participants are included in this research endeavor?
"Affirmative, the records available on clinicaltrials.gov demonstrate that this scientific investigation is presently recruiting volunteers. This trial was initially posted on September 15th 2020 and underwent its latest update November 18th 2022. The research team needs to recruit 25 individuals at a single medical facility."
Answered by AI
Is there currently an opportunity for individuals to enroll in this research?
"Affirmative. Based on information available through clinicaltrials.gov, the medical experiment, which was first listed on September 15th 2020, is actively recruiting participants. 25 individuals are needed to be enlisted from 1 centre."
Answered by AI
Has Letermovir been authorized by the FDA?
"Having been tested in a Phase 2 trial, the safety of Letermovir has been confirmed to some extent and was thus rated with a score of 2. Despite this, there is no data available yet demonstrating its efficacy."
Answered by AI
Is this investigation the inaugural exploration of its type?
"Exploration of Letermovir began in 2019, when a research project funded by Merck Sharp & Dohme LLC was launched. After successfully completing the Phase 1 clinical trial involving 86 participants, it moved to its second phase and officially gained approval from governing bodies. At present there are 7 on-going studies of this medication taking place across 11 countries with 34 cities hosting them."
Answered by AI
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