Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Summary

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