Vaccine Therapy for Blood Cancers

Recruiting at 4 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: City of Hope Medical Center

Must not be taking: Live vaccines, Antivirals, Alemtuzumab, others

Disqualifiers: Autoimmune conditions, Pregnancy, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

61 Participants Needed

Trial Summary

What is the purpose of this trial?

This randomized phase II trial studies how well vaccine therapy works in reducing the frequency of cytomegalovirus severe infections (events) in patients with hematologic malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help the body build an effective immune response and may reduce cytomegalovirus events after donor stem cell transplant.

Research Team

Ryotaro Nakamura, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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.

Inclusion Criteria

My leukemia is in an early or slightly advanced stage.

Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT

My leukemia is in the first or second remission without worsening, despite some lymph node swelling.

Exclusion Criteria

Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures, e.g., social/psychological issues, etc

You have not previously participated in a study involving an experimental CMV vaccine.

I will be taking specific medications from my transplant until day 70 after.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CMVpp65-A*0201 peptide vaccine or placebo subcutaneously on days 28 and 56 after HCT

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including CMV reactivation and immune response

Up to 365 days after HCT

Treatment Details

Interventions

• CMVpp65-A*0201 peptide vaccine

Trial Overview 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.

Participant Groups

Group I: Arm I (CMVpp65-A*0201 peptide vaccine) Experimental Treatment 2 Interventions

Patients receive CMVpp65-A\*0201 peptide vaccine SC on days 28 and 56 after HCT.

Group II: Arm II (placebo) Placebo Group 2 Interventions

Patients receive placebo SC on days 28 and 56 after HCT.

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+