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Clinical Trial Summary

This phase II trial studies how well multi-peptide CMV-modified vaccinia Ankara (CMV-MVA Triplex) vaccination of stem cell donors works in preventing cytomegalovirus (CMV) viremia in participants with blood cancer undergoing donor stem cell transplant. Giving a vaccine to the donors may boost the recipient's immunity to this virus and reduce the chance of CMV disease after transplant.


Clinical Trial 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 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. ;


Study Design


Related Conditions & MeSH terms

  • Accelerated Phase CML, BCR-ABL1 Positive
  • Acute Lymphoblastic Leukemia in Remission
  • Acute Myeloid Leukemia in Remission
  • Chronic Lymphocytic Leukemia
  • Chronic Phase CML, BCR-ABL1 Positive
  • Cytomegalovirus Positive
  • Donor
  • Hematopoietic and Lymphoid Cell Neoplasm
  • Hematopoietic Cell Transplant Recipient
  • Hodgkin Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • Myelodysplastic-Myeloproliferative Diseases
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Myelofibrosis
  • Myeloproliferative Disorders
  • Neoplasms
  • Non-Hodgkin Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Viremia

NCT number NCT03560752
Study type Interventional
Source City of Hope Medical Center
Contact
Status Active, not recruiting
Phase Phase 1
Start date August 20, 2018
Completion date June 18, 2024

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