A Phase 1 interventional study of Allogeneic Hematopoietic Stem Cell Transplantation and Biospecimen Collection in Cytomegaloviral Infection and Hematopoietic and Lymphoid System Neoplasm, sponsored by Roswell Park Cancer Institute. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-27.
Sponsored by Roswell Park Cancer Institute · Phase 1, Interventional, and Prevention
This phase Ib trial evaluates the safety and most effective dose of a cytomegalovirus (CMV) pp65 peptide-loaded alpha-type-1 polarized dendritic cell (CMV-alphaDC1) vaccination in patients who are undergoing an allogeneic hematopoietic stem cell transplant. CMV is an opportunistic infection that can occur or reactivate after allogeneic hematopoietic stem cell transplant as a result of immunosuppression. The CMV-alphaDC1 vaccine is made of white blood cells that have been exposed to molecules called cytokines, as well as CMV proteins. Introducing these dendritic cells to the patients immune system may activate an immune response to CMV, protecting against infection or reactivation.
PRIMARY OBJECTIVES:
I. Determine the safety of cytomegalovirus (CMV) pp65 peptide loaded alpha-type 1 polarized dendritic cell (CMV-alphaDC1) vaccination after allogeneic hematopoietic cell transplantation (alloHCT).
II. Determine the immunogenicity of CMV-alphaDC1 vaccination after alloHCT.
SECONDARY OBJECTIVES:
I. Evaluate the effect of CMV-alphaDC1 vaccination after alloHCT on late CMV reactivation.
II. Evaluate the effect of CMV-alphaDC1 vaccination after alloHCT on non-relapse mortality (NRM).
EXPLORATORY OBJECTIVES:
I. Assess the effect of CMV-alphaDC1 vaccination on T cell subsets. II. Assess the effect of CMV-alphaDC1 vaccination on T cell receptor diversity.
OUTLINE:
On day 0, patients undergo standard of care hematopoietic stem cell infusion. Patients receive CMV-alphaDC1 vaccine intradermally on days 28, 42, 56, and 70.
After completion of study treatment, patients are followed up at days 84, 100, 180, and 365.
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Exclusion Criteria:
Patients undergo standard of care allogeneic hematopoietic stem cell transplant on day 0 and receive CMV-alphaDC1 vaccine intradermally on days 28, 42, 56, and 70.
Procedure: Allogeneic Hematopoietic Stem Cell Transplantation · Procedure: Biospecimen Collection · Biological: CMV pp65 Peptide-loaded Alpha-type-1 Polarized Dendritic Cell Vaccine
Undergo standard of care allogeneic hematopoietic stem cell transplant
Also known as: Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC, HSCT, Stem Cell Transplantation, Allogeneic
Correlative studies
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Given intradermally
Also known as: CMV pp65 Peptide-loaded Alpha-type-1 Polarized DC Vaccine, Cytomegalovirus pp65 Peptide Loaded Alpha-type 1 Polarized Dendritic Cell Vaccine
Incidence of dose limiting toxicities
For each dose level of cytomegalovirus (CMV) pp65 peptide loaded alpha-type 1 polarized dendritic cell (CMV-alphaDC1) vaccination that is tested. Will be summarized by dose level using frequencies and relative frequencies.
Time frame: Up to 2 years
Number of multifunctional CMV antigen specific T cells
The number of multifunctional CMV antigen specific T cells will be determined by flow cytometry before and after vaccination with CMV-alphaDC1. Assessed by the change in the number of CMV specific T cells before and after treatment, which is compared using a one-sided paired t-test. The number of CMV specific T cells will be summarized before and after treatment using the appropriate descriptive statistics, with the mean change estimated using a 90% confidence interval.
Time frame: At days 28 (before vaccination), 42 (before vaccination), 56, 70, 84, 100, 180, 365
Number of CMV pp56 reactive T cells
The number of CMV pp65 reactive T cells will be determined by cytokine secretion (such as IFN-gamma) with ELISPOT before and after vaccination with CMV-alphaDC1. Assessed by the change in the number of CMV specific T cells before and after treatment, which is compared using a one-sided paired t-test. The number of CMV specific T cells will be summarized before and after treatment using the appropriate descriptive statistics, with the mean change estimated using a 90% confidence interval.
Time frame: At days 28 (before vaccination), 42 (before vaccination), 56, 70, 84, 100, 180, 365
Incidence of late CMV reactivation after allogeneic hematopoietic stem cell transplant
Will be summarized by dose level using the appropriate descriptive statistics; with estimates of rates obtained by 95% Jeffrey's prior confidence intervals.
Time frame: From day 85 to 365
Incidence of non-relapse mortality after allogeneic hematopoietic stem cell transplant
Will be summarized by dose level using the appropriate descriptive statistics; with estimates of rates obtained by 95% Jeffrey's prior confidence intervals.
Time frame: Up to 2 years
Number of T cells
Includes CD4 T-cells, CD8 T-cells, delta gamma T-cells, and natural killer T-cells. Will be modeled as a function of time (treated as discrete) and random subject effect (through use of an auto-regressive covariance structure) with a linear mixed model. Mean differences of interest (i.e., changes after vaccination) will be evaluated by using Holm-Bonferroni adjusted tests on the appropriate contrasts of model estimates. All model assumptions will be evaluated graphically, and transformations will be applied as appropriate.
Time frame: 1 year
T cell receptor diversity
Measured by Vbeta spectra-typing. Will be modeled as a function of time (treated as discrete) and random subject effect (through use of an auto-regressive covariance structure) with a linear mixed model. Mean differences of interest (i.e., changes after vaccination) will be evaluated by using Holm-Bonferroni adjusted tests on the appropriate contrasts of model estimates. All model assumptions will be evaluated graphically, and transformations will be applied as appropriate.
Time frame: 1 year
Incidence of adverse events
Toxicities and adverse events (as per Common Terminology Criteria for Adverse Events version 5.0) will be summarized by attribution and grade using frequencies and relative frequencies.
Time frame: Up to 2 years
This study is withdrawn, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Roswell Park Cancer Institute