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Vaccine Therapy for Blood Cancers

Phase 2
Waitlist Available
Led By Ryotaro Nakamura, MD
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 100 days after transplant
Awards & highlights

Study Summary

This trial looks at how well a vaccine can reduce the number of cytomegalovirus infections in people with blood cancer who are getting a stem cell transplant from a donor.

Who is the study for?
This trial is for patients with blood cancers like lymphoma, leukemia, and myelodysplastic syndrome who are undergoing stem cell transplants. They must understand the study, agree to follow-up procedures for a year post-transplant, be HLA A*0201 positive, CMV seropositive, not pregnant or breastfeeding, willing to use contraception and have no recent experimental anti-CMV treatments.Check my eligibility
What is being tested?
The trial tests if a vaccine made from a peptide can reduce severe cytomegalovirus infections in patients after donor stem cell transplant. It's randomized: some get the actual vaccine while others receive a placebo. The goal is to see how well the immune system responds.See study design
What are the potential side effects?
While specific side effects aren't listed here, vaccines may cause reactions at the injection site (like pain or swelling), feverish feelings or chills shortly after administration. More serious side effects could include allergic reactions or affecting other parts of the immune system.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 100 days after transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 100 days after transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cumulative Incidence of CMV at 100 Days
Secondary outcome measures
Cumulative Incidence of Relapse at One Year
Non-Relapse Mortality (NRM) at 100 Days

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (CMVpp65-A*0201 peptide vaccine)Experimental Treatment2 Interventions
Patients receive CMVpp65-A*0201 peptide vaccine SC on days 28 and 56 after HCT.
Group II: Arm II (placebo)Placebo Group2 Interventions
Patients receive placebo SC on days 28 and 56 after HCT.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CMVpp65-A*0201 peptide vaccine
1997
Completed Phase 1
~50

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,302 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,555 Total Patients Enrolled
Ryotaro Nakamura, MDPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
175 Total Patients Enrolled

Media Library

CMVpp65-A*0201 peptide vaccine Clinical Trial Eligibility Overview. Trial Name: NCT02396134 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Arm II (placebo), Arm I (CMVpp65-A*0201 peptide vaccine)
Acute Myeloid Leukemia Clinical Trial 2023: CMVpp65-A*0201 peptide vaccine Highlights & Side Effects. Trial Name: NCT02396134 — Phase 2
CMVpp65-A*0201 peptide vaccine 2023 Treatment Timeline for Medical Study. Trial Name: NCT02396134 — Phase 2
~6 spots leftby May 2025
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