Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant

Summary

This randomized phase I trial studies the side effects of vaccine therapy in preventing cytomegalovirus (CMV) infection in patients with hematological malignancies undergoing donor stem cell transplant. Vaccines made from a tetanus-CMV peptide or antigen may help the body build an effective immune response and prevent or delay the recurrence of CMV infection in patients undergoing donor stem cell transplant for hematological malignancies.

Conditions

• Accelerated Phase Chronic Myelogenous Leukemia
• Adult Acute Lymphoblastic Leukemia in Remission
• Adult Acute Myeloid Leukemia in Remission
• Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
• Adult Acute Myeloid Leukemia With Del(5q)
• Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
• Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
• Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
• Adult Acute Promyelocytic Leukemia (M3)
• Adult Nasal Type Extranodal NK/T-cell Lymphoma
• Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
• Anaplastic Large Cell Lymphoma
• B-cell Adult Acute Lymphoblastic Leukemia
• Chronic Eosinophilic Leukemia
• Chronic Myelomonocytic Leukemia
• Chronic Phase Chronic Myelogenous Leukemia
• Contiguous Stage II Adult Burkitt Lymphoma
• Contiguous Stage II Adult Diffuse Large Cell Lymphoma
• Contiguous Stage II Adult Lymphoblastic Lymphoma
• Contiguous Stage II Grade 1 Follicular Lymphoma
• Contiguous Stage II Grade 2 Follicular Lymphoma
• Contiguous Stage II Grade 3 Follicular Lymphoma
• Contiguous Stage II Mantle Cell Lymphoma
• Contiguous Stage II Small Lymphocytic Lymphoma
• Cytomegalovirus Infection
• de Novo Myelodysplastic Syndromes
• Essential Thrombocythemia
• Extramedullary Plasmacytoma
• Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
• Isolated Plasmacytoma of Bone
• Monoclonal Gammopathy of Undetermined Significance
• Nodal Marginal Zone B-cell Lymphoma
• Noncontiguous Stage II Adult Burkitt Lymphoma
• Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
• Noncontiguous Stage II Adult Lymphoblastic Lymphoma
• Noncontiguous Stage II Grade 1 Follicular Lymphoma
• Noncontiguous Stage II Grade 2 Follicular Lymphoma
• Noncontiguous Stage II Grade 3 Follicular Lymphoma
• Noncontiguous Stage II Mantle Cell Lymphoma
• Noncontiguous Stage II Small Lymphocytic Lymphoma
• Peripheral T-cell Lymphoma
• Polycythemia Vera
• Post-transplant Lymphoproliferative Disorder
• Previously Treated Myelodysplastic Syndromes
• Primary Central Nervous System Hodgkin Lymphoma
• Primary Central Nervous System Non-Hodgkin Lymphoma
• Primary Myelofibrosis
• Progressive Hairy Cell Leukemia, Initial Treatment
• Prolymphocytic Leukemia
• Recurrent Adult Acute Lymphoblastic Leukemia
• Recurrent Adult Acute Myeloid Leukemia
• Recurrent Adult Burkitt Lymphoma
• Recurrent Adult Diffuse Large Cell Lymphoma
• Recurrent Adult Hodgkin Lymphoma
• Recurrent Adult Lymphoblastic Lymphoma
• Recurrent Adult T-cell Leukemia/Lymphoma
• Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
• Recurrent Grade 1 Follicular Lymphoma
• Recurrent Grade 2 Follicular Lymphoma
• Recurrent Grade 3 Follicular Lymphoma
• Recurrent Mantle Cell Lymphoma
• Recurrent Mycosis Fungoides/Sezary Syndrome
• Recurrent Small Lymphocytic Lymphoma
• Refractory Chronic Lymphocytic Leukemia
• Refractory Hairy Cell Leukemia
• Refractory Multiple Myeloma
• Relapsing Chronic Myelogenous Leukemia
• Secondary Acute Myeloid Leukemia
• Secondary Myelodysplastic Syndromes
• Stage I Adult Burkitt Lymphoma
• Stage I Adult Diffuse Large Cell Lymphoma
• Stage I Adult Hodgkin Lymphoma
• Stage I Adult Lymphoblastic Lymphoma
• Stage I Adult T-cell Leukemia/Lymphoma
• Stage I Chronic Lymphocytic Leukemia
• Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage I Grade 1 Follicular Lymphoma
• Stage I Grade 2 Follicular Lymphoma
• Stage I Grade 3 Follicular Lymphoma
• Stage I Mantle Cell Lymphoma
• Stage I Multiple Myeloma
• Stage I Small Lymphocytic Lymphoma
• Stage IA Mycosis Fungoides/Sezary Syndrome
• Stage IB Mycosis Fungoides/Sezary Syndrome
• Stage II Adult Hodgkin Lymphoma
• Stage II Adult T-cell Leukemia/Lymphoma
• Stage II Chronic Lymphocytic Leukemia
• Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage II Multiple Myeloma
• Stage IIA Mycosis Fungoides/Sezary Syndrome
• Stage IIB Mycosis Fungoides/Sezary Syndrome
• Stage III Adult Burkitt Lymphoma
• Stage III Adult Diffuse Large Cell Lymphoma
• Stage III Adult Hodgkin Lymphoma
• Stage III Adult Lymphoblastic Lymphoma
• Stage III Adult T-cell Leukemia/Lymphoma
• Stage III Chronic Lymphocytic Leukemia
• Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage III Grade 1 Follicular Lymphoma
• Stage III Grade 2 Follicular Lymphoma
• Stage III Grade 3 Follicular Lymphoma
• Stage III Mantle Cell Lymphoma
• Stage III Multiple Myeloma
• Stage III Small Lymphocytic Lymphoma
• Stage IIIA Mycosis Fungoides/Sezary Syndrome
• Stage IIIB Mycosis Fungoides/Sezary Syndrome
• Stage IV Adult Burkitt Lymphoma
• Stage IV Adult Diffuse Large Cell Lymphoma
• Stage IV Adult Hodgkin Lymphoma
• Stage IV Adult Lymphoblastic Lymphoma
• Stage IV Adult T-cell Leukemia/Lymphoma
• Stage IV Chronic Lymphocytic Leukemia
• Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
• Stage IV Grade 1 Follicular Lymphoma
• Stage IV Grade 2 Follicular Lymphoma
• Stage IV Grade 3 Follicular Lymphoma
• Stage IV Mantle Cell Lymphoma
• Stage IV Small Lymphocytic Lymphoma
• Stage IVA Mycosis Fungoides/Sezary Syndrome
• Stage IVB Mycosis Fungoides/Sezary Syndrome
• T-cell Adult Acute Lymphoblastic Leukemia
• T-cell Large Granular Lymphocyte Leukemia
• Untreated Adult Acute Myeloid Leukemia
• Untreated Hairy Cell Leukemia
• Waldenström Macroglobulinemia

Interventions

BIOLOGICAL

tetanus-CMV fusion peptide vaccine

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 · City of Hope Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-10-29

Primary Completion

2024-02-02

Completion

2024-02-02

Countries

• United States

Study Locations