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Virus Therapy
Letermovir for CMV Prophylaxis After Cell Therapy
N/A
Waitlist Available
Led By George Chen, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18 years of age
Scheduled for SOC AXI-CEL
Must not have
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 psychiatric illness/social situations that would limit compliance with study requirements
Female participants who are pregnant or breastfeeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to find out if a drug called Letermovir can help stop the reactivation of CMV.
Who is the study for?
This trial is for adults over 18 who are scheduled to receive standard-of-care axicabtagene ciloleucel (AXI-CEL) therapy, have a performance status indicating they can carry out daily activities with ease or with some limitation, and are CMV seropositive. They must have adequate kidney function and liver function (if liver disease is present), and agree to use contraception if of child-bearing potential.
What is being tested?
The study aims to determine the effectiveness of Letermovir in preventing Cytomegalovirus (CMV) reactivation in patients undergoing AXI-CEL therapy. It's an open-label pilot trial, meaning both researchers and participants know what treatment is being given.
What are the potential side effects?
Potential side effects of Letermovir include headache, nausea, vomiting, diarrhea, abdominal pain, fatigue, coughing, swelling in the limbs (edema), decreased appetite and possible impact on blood cell counts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I am scheduled for standard AXI-CEL therapy.
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I am fully active or can carry out light work.
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My liver disease is mild to moderate.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have any serious illnesses that are not under control.
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I am not pregnant or breastfeeding.
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My liver disease is severe (Child-Pugh C).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion; an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and Adverse Events (AEs)
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%
Febrile neutropenia
8%
Hyperkalaemia
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%
Hepatic function abnormal
1%
Sinusitis
1%
Viral haemorrhagic cystitis
1%
Urinary tract infection
1%
Pneumothorax
1%
Venoocclusive liver disease
1%
Multiple organ dysfunction syndrome
1%
Pneumonia bacterial
1%
Staphylococcal bacteraemia
1%
Gastroenteritis
1%
Squamous cell carcinoma
1%
Plasma cell myeloma recurrent
1%
Gastrointestinal haemorrhage
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
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: Open label Single arm: LetermovirExperimental Treatment1 Intervention
Participants will be identified/recruited/screened from the Lymphoma and Stem Cell Transplantation and Cellular Therapy services at MD Anderson Cancer Center.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letermovir
2019
Completed Phase 3
~1530
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
3,070 Previous Clinical Trials
1,802,791 Total Patients Enrolled
George Chen, MDPrincipal InvestigatorM.D. Anderson Cancer Center