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Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant

NCT02396134 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2025-03-03

Study results available
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Summary

This randomized phase II trial studies how well vaccine therapy works in reducing the frequency of cytomegalovirus severe infections (events) in patients with hematologic malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help the body build an effective immune response and may reduce cytomegalovirus events after donor stem cell transplant.

Conditions

  • Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Adult Acute Lymphoblastic Leukemia in Remission
  • Adult Acute Myeloid Leukemia in Remission
  • Adult Hodgkin Lymphoma
  • Adult Non-Hodgkin Lymphoma
  • Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Cytomegaloviral Infection
  • Hematopoietic and Lymphoid Cell Neoplasm
  • HLA-A*0201 Positive Cells Present
  • Myelodysplastic Syndrome
  • Adult Lymphoblastic Lymphoma
  • Chronic Lymphocytic Leukemia
  • Myelofibrosis
  • Myeloproliferative Neoplasm

Interventions

BIOLOGICAL

CMVpp65-A*0201 peptide vaccine

Given SC

OTHER

Placebo

Given SC

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Ryotaro Nakamura, MD · City of Hope Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-21
Primary Completion
2018-03-04
Completion
2024-09-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02396134 on ClinicalTrials.gov