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Virus Therapy
Triplex Vaccine for CMV Prevention Post-Stem Cell Transplant
Phase 2
Waitlist Available
Led By Ryotaro Nakamura
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase
Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and active hepatitis B virus (HBV) (surface antigen negative) within 2 months of registration and no history of disseminated cutaneous human papillomavirus (HPV) related disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first injection to days 100 and 180 post-hematopoietic stem cell transplant (hct)
Awards & highlights
Study Summary
This trial will study how well the Triplex vaccine works in preventing CMV infection in patients undergoing a hematopoietic stem cell transplantation.
Who is the study for?
This trial is for patients with certain blood cancers like leukemia and lymphoma, who are undergoing stem cell transplantation and are at risk of CMV infection. They must be CMV positive, agree to use contraception, and not have received any prior investigational CMV vaccines or treatments that could affect the immune system.Check my eligibility
What is being tested?
The study tests the Triplex vaccine's effectiveness in preventing CMV infection post-stem cell transplant. The vaccine contains three pieces of CMV DNA within a weakened virus to stimulate immunity against this potentially harmful virus in immunocompromised individuals.See study design
What are the potential side effects?
Potential side effects may include typical vaccine reactions such as soreness at injection site, fever, fatigue, muscle pain. Since it involves genetic material within a weakened virus vector, there might also be risks related to immune responses or interaction with other medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My leukemia is in an early or slightly advanced stage.
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I do not have HIV, hepatitis C, active hepatitis B, or widespread HPV-related skin disease.
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I am scheduled for a stem cell transplant with minimal T-cell removal.
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I have been diagnosed with lymphoma.
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I am scheduled for a stem cell transplant with a half-matched donor.
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I am scheduled for a stem cell or bone marrow transplant for blood cancer treatment.
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My acute myeloid leukemia is in the first or second remission.
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I have been diagnosed with myelodysplastic syndrome.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from first injection to days 100 and 180 post-hematopoietic stem cell transplant (hct)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first injection to days 100 and 180 post-hematopoietic stem cell transplant (hct)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Clinically significant cytomegalovirus (CMV) reactivation prompting antiviral therapy or CMV disease
Secondary outcome measures
All-cause mortality
Duration of anti-CMV therapy
Duration of viremia
+14 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (letermovir, Triplex)Experimental Treatment2 Interventions
Patients receive letermovir per SOC on days 7-100 and multi-peptide CMV-modified vaccinia Ankara vaccine IM on days 100 and 128 post-HCT.
Group II: Arm II (letermovir, placebo)Active Control2 Interventions
Patients receive letermovir per SOC on days 7-100 and placebo IM on days 100 and 128 post-HCT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Letermovir
2019
Completed Phase 3
~1410
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,141 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
565 Previous Clinical Trials
1,921,448 Total Patients Enrolled
Ryotaro NakamuraPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
240 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My leukemia is in an early or slightly advanced stage.I have a blood cancer that is not multiple myeloma or aplastic anemia, as judged appropriate by the study's lead doctors.I haven't taken immunosuppressive drugs for an autoimmune disease in the last 5 years.My condition is advanced and includes CML in blast crisis, AML/ALL beyond 2nd remission, multiple myeloma, or aplastic anemia.I have undergone specific treatments within 30 days before or up to 180 days after a stem cell transplant.I am scheduled for a stem cell transplant with minimal T-cell removal.I am not in any other clinical trials with new drugs from the time of my transplant to 70 days after.I have been diagnosed with lymphoma.I do not have HIV, hepatitis C, active hepatitis B, or widespread HPV-related skin disease.You have never participated in a study for an experimental CMV vaccine before.I am scheduled for a stem cell transplant with a half-matched donor.I have not had a transplant for multiple myeloma or aplastic anemia, and this is my first haploHCT.I have received vaccines like flu, HPV, or hepatitis B shots after my cell transplant.I have received CMV prevention treatment, but not Prevymis, after my transplant.I am scheduled for a stem cell or bone marrow transplant for blood cancer treatment.I haven't received T-cell depleting agents or CD34+ selection from HCT to 70 days after.My leukemia is in the first or second remission without worsening despite lymph node swelling.I have received radiation therapy for my disease after my stem cell transplant.I have not taken experimental anti-CMV drugs in the past 6 months.I am receiving allergy shots from the time of my cell transplant until 70 days after.I am taking antiviral medication that works against CMV, except for acyclovir.I have not received any live vaccines since my cell transplant.I am not taking any medications that could affect the study treatment's evaluation.My acute myeloid leukemia is in the first or second remission.I am undergoing or have undergone intense or reduced intensity bone marrow treatment.I am following my hospital's guidelines for immune system treatments.I have been diagnosed with myelodysplastic syndrome.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (letermovir, Triplex)
- Group 2: Arm II (letermovir, placebo)
Awards:
This trial has 0 awards, including: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.
What is the maximum capacity of participants for this research endeavor?
"Affirmative. According to clinicaltrials.gov, this research programme is actively recruiting participants since its debut on October 7th 2019 and most recent edit on August 30th 2022. The medical trial requires 128 patients across a single site."
Answered by AI
What therapeutic applications has the Multi-peptide CMV-Modified Vaccinia Ankara Vaccine been utilized for?
"The Multi-peptide CMV-Modified Vaccinia Ankara Vaccine is primarily administered in cases where first or second generation smallpox vaccines are contraindicated. It can also work to combat cmv seropositive, hemorrhagic fever, ebola, and cytomegalovirus infections."
Answered by AI
Is there still capacity for participants in this experimentation?
"Affirmative, clinicaltrials.gov reports that recruitment for this medical trial is currently underway. This study was initially shared on October 7th 2019 and its parameters were last revised on August 30th 2022; 128 individuals are being sought from 1 site."
Answered by AI
What potential risks have been identified with the use of Multi-peptide CMV-Modified Vaccinia Ankara Vaccine?
"Judging by the Phase 2 nature of this clinical trial, which provides evidence of safety but not efficacy, Power's team has assigned a score of 2 to Multi-peptide CMV-Modified Vaccinia Ankara Vaccine in terms of its security."
Answered by AI
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