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CMV-MVA Triplex Vaccination of Stem Cell Donors in Preventing CMV Viremia in Participants With Allogeneic Transplant

Chronic Lymphocytic Leukemia Clinical Trial

Official title:
CMV-MVA Triplex Vaccination of Stem Cell Donors to Enhance CMV Specific Immunity and Prevent CMV Viremia in Recipients After Stem Cell Transplant

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
Clinical Trial Details
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
View Details
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