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Clinical Trial Summary

This randomized phase II trial studies how well multi-antigen cytomegalovirus (CMV)-modified vaccinia Ankara vaccine works in reducing CMV related complications in patients with blood cancer who are undergoing donor stem cell transplant. Vaccines made from a gene-modified virus may help the body build an effective immune response to kill cancer cells.


Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine if multi-antigen CMV-modified vaccinia Ankara vaccine (CMV-modified vaccinia Ankara [MVA] triplex) reduces the frequency of CMV events, defined as reactivation or CMV disease in CMV+, haploidentical hematopoietic cell transplantation (haploHCT) recipients.

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of CMV-MVA triplex in vaccinated, haploHCT recipients by assessing the following: non-relapse mortality (NRM) at 100 days post hematopoietic cell transplantation (HCT), severe (grade 3-4) acute graft versus host disease (GVHD), and grade 3-4 adverse events (AEs) probably or definitely related to the vaccination within 2 weeks from each vaccination.

II. To characterize CMV related events in recipients of CMV-MVA triplex compared to placebo, by assessing time to viremia (number of days from transplantation to the date of >= 1250 IU/mL), duration of viremia, recurrence of viremia, incidence of late CMV viremia/disease (> 100 and =< 360 days post HCT), use of antiviral drugs (triggered by clinically significant viremia of >= 1250 IU/mL), cumulative number of CMV specific antiviral treatment days.

III. To evaluate the impact of CMV-MVA triplex on transplant related outcomes by assessing the incidence of acute graft versus host disease (aGVHD), chronic GVHD, relapse, non-relapse mortality, all-cause mortality, infections.

IV. To determine if CMV-MVA triplex increases levels, function and kinetics of CMV-specific T cell immunity in vaccinated compared to placebo treated, CMV seropositive HCT-recipients.

V. To determine whether vaccination induces adaptive natural killer (NK) cell population changes, and increase in the highly cytotoxic memory NKG2C+ NK cell.

VI. To compare GVHD biomarkers between the vaccine and placebo groups.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients receive multi-antigen CMV-modified vaccinia Ankara vaccine intramuscularly (IM) on days 28 and 56 post-HCT.

ARM II: Patients receive placebo IM on days 28 and 56 post-HCT.

After completion of study treatment, patients are followed up at 100, 140, 180, 270, and 365 days, and then periodically for 3 years. ;


Study Design


Related Conditions & MeSH terms

  • Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Acute Lymphoblastic Leukemia in Remission
  • Acute Myeloid Leukemia in Remission
  • Bone Marrow Transplantation Recipient
  • Chronic Lymphocytic Leukemia
  • Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Hematopoietic Cell Transplantation Recipient
  • Hodgkin Disease
  • Hodgkin Lymphoma
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Leukemia, Myeloid
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid, Chronic-Phase
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Myelodysplastic Syndrome
  • Myelodysplastic Syndromes
  • Myelofibrosis
  • Myeloproliferative Disorders
  • Myeloproliferative Neoplasm
  • Non-Hodgkin Lymphoma
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Preleukemia
  • Primary Myelofibrosis

NCT number NCT03438344
Study type Interventional
Source City of Hope Medical Center
Contact
Status Withdrawn
Phase Phase 2
Start date December 2018
Completion date December 2021

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