Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
|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||Biological: tetanus-CMV fusion peptide vaccine Other: laboratory biomarker analysis||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Supportive Care
|Official Title:||A Phase I Trial to Evaluate Safety and Immunogenicity of a Cytomegalovirus Peptide Vaccine Co-Injected With PF-03512676 Adjuvant in Recipients of Allogeneic Hematopoietic Stem Cell Transplant|
- Safety based on assessment of GVHD, graded according to the Keystone Consensus system and adverse events (AEs) based on National Cancer Institute (NCI) CTCAE version 4.03 [ Time Frame: Up to day 180 ]GVHD, local and systemic reactogenicity, and toxicity related to the vaccine formulation will be evaluated by the study principal investigator (PI), conferring with the treating physician. AEs will be summarized for each treatment group by type (MedDRA codes within organ systems), grade, and attribution.
- Immunogenicity evaluated by monitoring CMV-specific CD8+ T cells by multi color flow cytometric analyses [ Time Frame: Up to day 180 ]Compare levels of CD8+ T cells binding to CMV-specific tetramers in vaccinated and unvaccinated HCT recipients by Wilcoxon rank-sum test, using integrated CMV-specific CD8+ T cells levels over the first 100 days as a numerical outcome. PD-1 expression and levels of apoptosis markers and proliferation of CMV-specific T cells immune-parameters will be compared in both arms using the Kruskall-Wallis rank-sum test.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Experimental: Arm I (vaccine therapy)
Patients receive Tet-CMV + PF03512675 SC on days 28 and 56 post-HCT.
Biological: tetanus-CMV fusion peptide vaccine
Given SCOther: laboratory biomarker analysis
Active Comparator: Arm II (control)
Patients undergo immune monitoring only.
Other: laboratory biomarker analysis
PRIMARY OBJECTIVES: I. To discover whether two administrations of 2.5 mg tetanus (Tet)-CMV peptide co-injected with 1 mg of PF-03512676 (tetanus-CMV fusion peptide vaccine), by subcutaneous (SC) route on days 28 and 56 post-hematopoietic cell transplantation (HCT) are safe and well tolerated in human leukocyte antigen (HLA) A*0201 CMV-positive recipients of allogeneic HCT.
I. To measure levels of CMV-specific T cells in vaccinated compared to unvaccinated HCT recipients (control arm).
II. To assess whether vaccination of HCT recipients with Tet-CMV co-injected with PF03512676 reduces expression of programmed death 1 (PD-1) on CMV-specific T cells.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive Tet-CMV + PF03512675 SC on days 28 and 56 post-HCT.
ARM II: Patients undergo immune monitoring only.
After completion of study treatment, patients are followed up at days 70, 84, 100, 130, 160, and 180.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588015
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|Principal Investigator:||Ryotaro Nakamura||City of Hope Medical Center|