Your session is about to expire
← Back to Search
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
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cumulative Incidence of CMV at 100 Days
Secondary study objectives
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
13,938 Previous Clinical Trials
41,023,109 Total Patients Enrolled
City of Hope Medical CenterLead Sponsor
602 Previous Clinical Trials
1,923,386 Total Patients Enrolled
Ryotaro Nakamura, MDPrincipal InvestigatorCity of Hope Medical Center
5 Previous Clinical Trials
175 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have not previously participated in a study involving an experimental CMV vaccine.My leukemia is in an early or slightly advanced stage.I will be taking specific medications from my transplant until day 70 after.You are currently receiving allergy treatment with injections of antigens.I have received vaccines like the flu shot or HPV vaccine.I am taking antiviral medication effective against CMV, except acyclovir.I am not taking any medications that could affect the study drug's evaluation.I have not received T-cell depleting treatments like Alemtuzumab.My leukemia is in the first or second remission without worsening, despite some lymph node swelling.I haven't taken immunosuppressive drugs for an autoimmune disease in the last 5 years.My acute myeloid leukemia is in the first or second remission.I have a blood cancer but not multiple myeloma or aplastic anemia.My genetic test shows I have the HLA A*0201 type.I am planning a stem cell transplant with a fully matched donor and have not had a previous allogeneic transplant.I have been diagnosed with lymphoma.I have been diagnosed with myelodysplastic syndrome.I haven't had experimental anti-CMV treatment in the past 6 months.I have not received any live vaccines recently.I am scheduled for a stem cell transplant without removing T cells from the graft.I am scheduled for a stem cell transplant to treat my blood cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (placebo)
- Group 2: Arm I (CMVpp65-A*0201 peptide vaccine)
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.