CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Blood Cancer Undergoing Donor Stem Cell Transplant
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Acute Lymphoblastic Leukemia in Remission
- Acute Myeloid Leukemia in Remission
- Chronic Lymphocytic Leukemia
- Myelodysplastic/Myeloproliferative Neoplasm
- Non Hodgkin Lymphoma
- Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
- Cytomegalovirus Positive
- Donor
- Hematopoietic and Lymphoid Cell Neoplasm
- Hematopoietic Cell Transplant Recipient
- Hodgkin Lymphoma
- Myelodysplastic Syndrome
- Myelofibrosis
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
PRIMARY OBJECTIVES: I. Establish the feasibility and safety of priming CMV immunity in donors by Triplex vaccination prior to peripheral blood stem cell (PBSC) harvest. SECONDARY OBJECTIVES: I. Examine if Triplex vaccination of hematopoietic stem cell transplant (HCT) donors has an impact on CMV eve...
PRIMARY OBJECTIVES: I. Establish the feasibility and safety of priming CMV immunity in donors by Triplex vaccination prior to peripheral blood stem cell (PBSC) harvest. SECONDARY OBJECTIVES: I. Examine if Triplex vaccination of hematopoietic stem cell transplant (HCT) donors has an impact on CMV events. OUTLINE: Donors receive multi-peptide CMV-modified vaccinia Ankara vaccine injection between days -60 and -10 prior to granulocyte colony stimulating factor mobilization. Participants undergo hematopoietic cell transplantation on day 0. After completion of study treatment, participants are followed up for 1 year.
Tracking Information
- NCT #
- NCT03560752
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Ryotaro Nakamura, MD City of Hope Medical Center
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