Chronic Lymphocytic Leukemia Clinical Trial
Official title:
A Phase II Randomized, Placebo-Controlled, Multicenter Trial to Evaluate the Protective Function of a CMV-MVA Triplex Vaccine in Recipients of a Haploidentical Hematopoietic Stem Cell Transplant
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.
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.
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