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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 100 days after transplant

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,092 Total Patients Enrolled

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,399 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to partake in this medical experiment?

"This clinical trial is recruiting 133 individuals with myeloproliferative neoplasms (MPNs) aged 18 to 75 who meet certain criteria. These include: no other hematologic malignancies, ability and willingness to sign an informed consent, agreement to comply with study procedures, lymphoma/myelodysplastic syndrome/acute leukemia in first or second remission etc. In addition all potential participants must be HLA A*0201 high resolution 4-digit typing positive and CMV seropositive."

Answered by AI

Is the CMVpp65-A*0201 peptide vaccine likely to cause any adverse effects in people?

"Although Phase 2 trials provide minimal evidence of safety, they do not demonstrate efficacy. As a result, the CMVpp65-A*0201 peptide vaccine was assessed at a score of 2."

Answered by AI

What venues in the US are administering this experimental program?

"The current clinical trial is running at Emory University Hospital/Winship Cancer Institute in Atlanta, Georgia, the University of Minnesota/Masonic Cancer Center in Minneapolis, Minnesota and City of Hope Medical Centre located in Duarte, California. Additionally there are five additional medical sites hosting this experiment."

Answered by AI

Is this trial open to participants with advanced age?

"Those that wish to participate in this trial must be 18-75 years of age. On the other hand, there are 933 clinical trials available to minors and 4801 for seniors."

Answered by AI

Are there any remaining openings for volunteers in this experiment?

"Clinicaltrials.gov affirms that this medical trial, initially posted on the 21st of May 2015, is no longer accepting patients. Fortunately, other trials are actively recruiting with 5,370 active clinical studies present at this moment in time."

Answered by AI

What is the fundamental purpose of this medical experiment?

"This trial, evaluated over a 365-day time frame post hematopoietic cell transplantation, seeks to measure the incidence of CMV reactivation or disease in recipients of standard Prevymis prophylaxis. Secondary objectives include determining the severity (grade 3-4) of acute Graft versus Host Disease (aGVHD), relapse rate and non-relapse mortality NRM)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant

2015. "Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02396134.

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