Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 30
Summary
- Conditions
- Accelerated Phase Chronic Myelogenous Leukemia
- Adult Acute Lymphoblastic Leukemia in Remission
- Stage III Mantle Cell Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Chronic Eosinophilic Leukemia
- Stage IA Mycosis Fungoides/Sezary Syndrome
- Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage I Adult Hodgkin Lymphoma
- Stage III Adult Lymphoblastic Lymphoma
- Contiguous Stage II Grade 3 Follicular Lymphoma
- Cytomegalovirus Infection
- Stage II Adult Hodgkin Lymphoma
- T-cell Adult Acute Lymphoblastic Leukemia
- Stage I Small Lymphocytic Lymphoma
- Previously Treated Myelodysplastic Syndromes
- Stage I Adult Lymphoblastic Lymphoma
- Stage I Chronic Lymphocytic Leukemia
- Stage IB Mycosis Fungoides/Sezary Syndrome
- Stage IIA Mycosis Fungoides/Sezary Syndrome
- Recurrent Mantle Cell Lymphoma
- Chronic Phase Chronic Myelogenous Leukemia
- 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)
- Stage IV Grade 1 Follicular Lymphoma
- Primary Myelofibrosis
- Stage III Grade 2 Follicular Lymphoma
- Stage I Grade 3 Follicular Lymphoma
- Adult Acute Myeloid Leukemia With t(15;17)(q22;q12)
- Stage II Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage II Multiple Myeloma
- Isolated Plasmacytoma of Bone
- Stage IVA Mycosis Fungoides/Sezary Syndrome
- Contiguous Stage II Adult Lymphoblastic Lymphoma
- Stage I Mantle Cell Lymphoma
- Stage IV Small Lymphocytic Lymphoma
- Primary Central Nervous System Non-Hodgkin Lymphoma
- Stage I Cutaneous T-cell Non-Hodgkin Lymphoma
- de Novo Myelodysplastic Syndromes
- Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
- Contiguous Stage II Small Lymphocytic Lymphoma
- Post Transplant Lymphoproliferative Disorder
- Recurrent Adult Acute Lymphoblastic Leukemia
- Stage IV Adult Diffuse Large Cell Lymphoma
- T-cell Large Granular Lymphocyte Leukemia
- Monoclonal Gammopathy of Undetermined Significance
- Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
- Extramedullary Plasmacytoma
- Stage I Adult Burkitt Lymphoma
- Stage IVB Mycosis Fungoides/Sezary Syndrome
- Stage I Adult T-cell Leukemia/Lymphoma
- Stage IIB Mycosis Fungoides/Sezary Syndrome
- Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage III Cutaneous T-cell Non-Hodgkin Lymphoma
- Stage III Multiple Myeloma
- Noncontiguous Stage II Small Lymphocytic Lymphoma
- Essential Thrombocythemia
- Stage II Chronic Lymphocytic Leukemia
- Refractory Multiple Myeloma
- Noncontiguous Stage II Grade 3 Follicular Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Nodal Marginal Zone B-cell Lymphoma
- Noncontiguous Stage II Grade 2 Follicular Lymphoma
- Stage III Chronic Lymphocytic Leukemia
- Recurrent Adult Diffuse Large Cell Lymphoma
- Contiguous Stage II Grade 1 Follicular Lymphoma
- Adult Acute Promyelocytic Leukemia (M3)
- Stage I Adult Diffuse Large Cell Lymphoma
- Recurrent Small Lymphocytic Lymphoma
- Polycythemia Vera
- Primary Central Nervous System Hodgkin Lymphoma
- Stage II Adult T-cell Leukemia/Lymphoma
- Secondary Acute Myeloid Leukemia
- Stage IV Adult Hodgkin Lymphoma
- Stage III Adult Burkitt Lymphoma
- Stage III Adult Diffuse Large Cell Lymphoma
- Refractory Chronic Lymphocytic Leukemia
- Stage IV Adult Lymphoblastic Lymphoma
- Untreated Adult Acute Myeloid Leukemia
- Secondary Myelodysplastic Syndromes
- Stage I Multiple Myeloma
- Stage III Adult Hodgkin Lymphoma
- Relapsing Chronic Myelogenous Leukemia
- B-cell Adult Acute Lymphoblastic Leukemia
- Recurrent Grade 2 Follicular Lymphoma
- Stage IV Grade 2 Follicular Lymphoma
- Contiguous Stage II Adult Diffuse Large Cell Lymphoma
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Contiguous Stage II Grade 2 Follicular Lymphoma
- Stage IIIB Mycosis Fungoides/Sezary Syndrome
- Stage IV Adult Burkitt Lymphoma
- Stage III Grade 3 Follicular Lymphoma
- Stage IIIA Mycosis Fungoides/Sezary Syndrome
- Noncontiguous Stage II Grade 1 Follicular Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Stage I Grade 2 Follicular Lymphoma
- Stage IV Grade 3 Follicular Lymphoma
- Noncontiguous Stage II Adult Diffuse Large Cell Lymphoma
- Contiguous Stage II Adult Burkitt Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Stage I Grade 1 Follicular Lymphoma
- Progressive Hairy Cell Leukemia, Initial Treatment
- Stage III Grade 1 Follicular Lymphoma
- Stage IV Chronic Lymphocytic Leukemia
- Recurrent Adult Burkitt Lymphoma
- Contiguous Stage II Mantle Cell Lymphoma
- Noncontiguous Stage II Adult Burkitt Lymphoma
- Peripheral T Cell Lymphoma
- Waldenstrom Macroglobulinemia
- Refractory Hairy Cell Leukemia
- Stage IV Mantle Cell Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Anaplastic Large Cell Lymphoma
- Noncontiguous Stage II Mantle Cell Lymphoma
- Untreated Hairy Cell Leukemia
- Recurrent Adult Acute Myeloid Leukemia
- Stage III Adult T-cell Leukemia/Lymphoma
- Stage IV Adult T-cell Leukemia/Lymphoma
- Stage III Small Lymphocytic Lymphoma
- Noncontiguous Stage II Adult Lymphoblastic Lymphoma
- Prolymphocytic Leukemia
- Recurrent Adult Hodgkin Lymphoma
- Chronic Myelomonocytic Leukemia
- Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 75 years
- Gender
- Both males and females
Description
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 huma...
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. SECONDARY OBJECTIVES: 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.
Tracking Information
- NCT #
- NCT01588015
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Ryotaro Nakamura City of Hope Medical Center
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