RecruitingPhase 2

CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors for the Prevention of CMV Infection in Patients Undergoing Hematopoietic Stem Cell Transplant

United States216 participantsStarted 2024-07-12

Plain-language summary

This phase II clinical trial tests how well the cytomegalovirus-modified vaccinica Ankara (CMV-MVA) Triplex vaccine given to human leukocyte antigens (HLA) matched related stem cell donors works to prevent cytomegalovirus (CMV) infection in patients undergoing hematopoietic stem cell transplant. The CMV-MVA Triplex vaccine works by causing an immune response in the donors body to the CMV virus, creating immunity to it. The donor then passes that immunity on to the patient upon receiving the stem cell transplant. Giving the CMV-MVA triplex vaccine to donors may help prevent CMV infection of patients undergoing stem cell transplantation.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion Criteria: * DONORS: Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * DONORS: Age: 18 and above * RECIPIENTS: Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * RECIPIENTS: Participant must be willing to comply with study and/or follow-up procedures, including willingness to be followed for one year post-HCT * RECIPIENTS: Age: 18 and above * RECIPIENTS: Karnofsky performance score ≥ 70 or ECOG ≤ 2 * RECIPIENTS: Planned HCT for the treatment of the following hematologic malignancies: lymphoma (Hodgkin and Non-Hodgkin), myelodysplastic syndrome, acute lymphoblastic leukemia in first or second remission, acute myeloid leukemia in first or second remission, chronic myelogenous leukemia (in first chronic or accelerated phase, or in second chronic phase), chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis. Patients with multiple myeloma are excluded * RECIPIENTS: CMV seropositive * RECIPIENTS: Planned related HCT with 8/8 (A, B, C, DRB1) high resolution human leukocyte antigen (HLA) donor allele matching * RECIPIENTS: Conditioning and immunosuppressive regimens according to institutional guidelines are permitted. Patients may receive myeloablative, reduced intensity, or nonmyeloablative conditioning * RECIPIENTS: Tot…

What they're measuring

Time from transplantation to cytomegalovirus (CMV) disease or pre-emptive treatment following CMV reactivation (efficacy)

Timeframe: From hematopoietic stem cell transplantation (HCT) to day 180

Occurrence of non-relapse mortality (safety in HCT-recipients)

Timeframe: Up to day 100 post HCT

Incidence of severe acute graft versus host disease (aGHVD) (safety in HCT-recipients)

Timeframe: Up to 100 days post HCT

Incidence of severe adverse events (AEs) (safety in HCT-recipients)

Timeframe: Within 2 weeks from transplantation and up to 1 year post HCT

Incidence of grade 3 and higher AEs (safety in HCT-donors)

Timeframe: Within 14 days

Trial details

NCT IDNCT06059391

SponsorCity of Hope Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01-01

Contact for this trial

Vaibhav Agrawal, MD

626-359-8111 vagrawal@coh.org

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials