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Vaccines

Immunologic Factors

Patients receive multi-antigen CMV-modified vaccinia Ankara vaccine via injection on days 28 and 56 post-HCT.

Patients receive placebo via injection on days 28 and 56 post-HCT.

Multi-antigen CMV-Modified Vaccinia Ankara Vaccine

Laboratory Biomarker Analysis

Placebo

Ryotaro Nakamura, MD

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.

Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Reducing CMV Related Complications in Patients With Blood Cancer Undergoing Donor Stem Cell Transplant

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

Will include any CMV reactivation (detection of \>= 1250 U/mL plasma), low-level reactivation prompting antiviral therapy, or CMV disease (defined by histology) prior to day 100 post-hematopoietic cell transplantation (HCT).

The primary statistical analyses will compare vaccine and placebo regarding hazards of CMV events from injection to day 100. Events prior to injection will inform Kaplan Meier estimates for both arms to obtain unbiased estimates of reactivation rates applicable to all transplanted subjects on each arm.

Will be scored using Keystone consensus criteria. Whenever possible, acute GVHD will be confirmed histologically with microscopic review.

Will also assess immunophenotyping and function.

Will assess cytotoxicity of NK cells against K562 target cell line compared with control (% killing) and cytokine production using flow-cytometry with intra-cellular staining of gamma-interferon and other cytokines (% of NK cells producing these cytokines).

City of Hope Medical Center

Bone Marrow Transplantation

CliniMACS CD34 Reagent System

Receive CD34-selected peripheral blood stem cells from related or unrelated donors

Peripheral Blood Stem Cell Transplantation

Eneida Nemecek, MD

Eneida R. Nemecek

This expanded access protocol studies bone marrow transplantation using CD34-selected stem cells from related or unrelated donors in treating participants with cancer or other disorders. Stem cells collected from the donor will be processed using a new device called CliniMACS CD34 Reagent System which marks the blood cells collected from the donor with a special protein called "antibody" that tags only the donor stem cells, sorting out other cells of the blood and immune system. This is done to remove, at least partially, some of the T cells. T cells are the cells in the blood that work as scavengers of the immune system deciding what belongs and what does not. These cells can sometimes cause rejection of the donor graft or a condition called graft-versus host disease (GVHD), where the donor cells can attack the body of the recipient. A bone marrow transplantation using CD34-selected stem cells may reduce the risk of these unwanted side effects of transplant as much as possible.

PRIMARY OBJECTIVES:

I. To provide a source of CD34-selected stem cells for patients with malignant and nonmalignant disorders undergoing bone marrow transplantation from haploidentical (human leukocyte antigen \[HLA\]-mismatched) related donors or HLA-compatible unrelated donors

SECONDARY OBJECTIVES:

I. Monitoring the safety of the CD34-selected stem cells for the recipient, as measured by adverse events related to stem cell infusion, incidence of engraftment of neutrophils and platelets, incidence of acute and chronic GVHD, and one year overall survival, disease-free survival, and primary disease recurrence.

OUTLINE:

Donor stem cells undergo CD34 selection ex vivo using the CliniMACS CD34 Reagent System using standard operating procedures (SOPs) from the manufacturer. Recipients undergo standard of care preparative regimen, bone marrow transplantation with CD34-selected peripheral blood stem cells via infusion over 1 to 2 hours on day 0, and then receive standard of care GVHD prophylaxis.

After completion of study treatment, recipients are followed up at least once weekly while inpatient until transplant day 100, every 1-3 months for the first year and yearly thereafter.

Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other Disorders

Institutional Protocol of Bone Marrow Transplantation Using CD34-Selected Peripheral Blood Stem Cells From Related Haploidentical or Unrelated Donors for Treatment of Malignant and Nonmalignant Disorders

Oregon Health and Science University

OHSU Knight Cancer Institute

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Reducing CMV Related Complications in Patients With Blood Cancer Undergoing Donor Stem Cell Transplant	NCT03438344	Accelerated Pha... Acute Lymphobla... Acute Myeloid L... Bone Marrow Tra... Chronic Lymphoc... Chronic Phase C... Hematopoietic C... Hodgkin Lymphom... Myelodysplastic... Myelofibrosis Myeloproliferat... Non-Hodgkin Lym...	Multi-antigen C... Laboratory Biom... Placebo	18 Years -	City of Hope Medical Center
Bone Marrow Transplantation Using CD34-Selected Stem Cells From Related or Unrelated Donors in Treating Participants With Cancer or Other Disorders	NCT03626285	Benign Neoplasm Bone Marrow Tra... Hematopoietic C... Malignant Neopl...	Bone Marrow Tra... CliniMACS CD34 ... Peripheral Bloo...	- 70 Years	OHSU Knight Cancer Institute
Multi-antigen CMV-Modified Vaccinia Ankara Vaccine in Reducing CMV Related Complications in Patients With Blood Cancer Undergoing Donor Stem Cell Transplant	NCT03438344	Accelerated Pha... Acute Lymphobla... Acute Myeloid L... Bone Marrow Tra... Chronic Lymphoc... Chronic Phase C... Hematopoietic C... Hodgkin Lymphom... Myelodysplastic... Myelofibrosis Myeloproliferat... Non-Hodgkin Lym...	Multi-antigen C... Laboratory Biom... Placebo	18 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for bone marrow transplantation recipient