Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
30

Inclusion Criteria

The use of alemtuzumab for immunosuppression is not permitted in this study
Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment is not allowed
Use of contraception up to 90 days post-HCT
...
The use of alemtuzumab for immunosuppression is not permitted in this study
Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment is not allowed
Use of contraception up to 90 days post-HCT
HLA A*0201 subtype
Leukemia, not otherwise specified (NOS)
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
All subjects must have the ability to understand and the willingness to sign a written informed consent
Antiviral treatment for herpes simplex virus (HSV), human herpes virus 6 (HHV6), Epstein-Barr virus (EBV) and adenovirus including the use of GVC/VAL, FOS, Cidofovir, CMX-001 may also suppress reactivation of CMV, thus it will not be allowed in this study; patients requiring such treatment before randomization (day 28) will be removed from the study and replaced; reasons for removal will be reported in the patient's CRF
Chronic lymphoid leukemia; adult T cell leukemia/lymphoma, chronic lymphocytic leukemia not otherwise specified (NOS), hairy cell leukemia; prolymphocytic leukemia (B or T); T cell large granular (gran.) lymphocytic (lymph.) leukemia (leuk)
All medications, supportive care, blood products or radiation therapy taken or administered during the trial will be documented in the subject's clinical/hospital and case report form (CRF), using City of Hope (COH) guidelines; the subject's clinical information will be recorded on the appropriate CRF
Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and active hepatitis B virus (HBV) (surface antigen negative)
Chronic myeloproliferative disease (CML); chronic eosinophilic leukemia (CEL)/hypereosinophilic syndrome; chronic idiopathic myelofibrosis; CML - Philadelphia chromosome; essential thrombocythemia; polycythemia vera
Lymphoma, NOS
Planned related or unrelated HCT, with 8/8 or 7/8 (A, B, C, DRB1) high resolution HLA donor allele matching
Willingness to be followed for the planned duration of the trial (6 months post-HCT)
Myelodysplastic syndrome, NOS; chronic myelomonocytic leukemia
Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections)
Myeloma, NOS; monoclonal gammopathy of undetermined significance (MGUS); solitary plasmacytoma
All enrolled recipients who will require anti-CMV therapy before day 28 will be replaced, treated and monitored as required by COH standard of care; GVC/VAL, FOS, Cidofovir, CMX-001 may be used according to COH standard of care (SOC) for preemptive management of CMV viremia; should antiviral treatment be required after day 28, the planned 2nd vaccine injection at day 56 will not be administered (vaccine arm only)
Hodgkin lymphoma, NOS; Hodgkin lymphoma nodular lymphocyte predominant (LP), NOS; Hodgkin lymphoma - like post-transplant lymphoproliferative disorder (PTLD)
Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status needs to be in hematologic remission by bone marrow/peripheral blood; persistent lymphadenopathy on computed tomography [CT] or CT/positron emission tomography [PET] scan without progression is allowed)
Acute lymphoblastic leukemia (ALL); B-precursor ALL; T cell ALL
Able and willing to sign the informed consent form (ICF)
Hodgkin and non-Hodgkin lymphoma
Non-Hodgkin lymphoma (NHL); anaplastic large-cell lymphoma (ALCL), cutaneous, ALCL, systemic; Burkitt lymphoma/leukemia; cutaneous T-cell lymphoma (CTCL)/mycosis fungoides; CTCL/Sezary syndrome; diffuse large B-cell lymphoma; mucosa associated lymphoid tissue (MALT)-lymphoma; extranodal natural killer (NK)/T cell lymphoma, extranodal NK/T lymphoma nasal; follicular lymphoma; lymphoplasmacytic lymphoma mantle cell lymphoma; mediastinal large B-cell lymphoma; nodal marginal zone B-cell lymphoma (lymph.); NHL aggressive, NOS; NHL indolent, NOS; NHL, NOS; peripheral T cell lymphoma, NOS; PTLD (monoclonal); PTLD (polyclonal); precursor (precur.) B-lymphoblastic lymphoma; precur T-lymphoblastic lymphoma; primary central nervous system (CNS) lymphoma; primary effusion lymphoma; small lymphocytic lymphoma, NOS
Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase
Planned HCT with minimal to no-T cell depletion of graft
Myelodysplastic syndrome
Concurrent enrollment in other clinical trials using an investigational product is prohibited
Acute myeloid leukemia (AML), acute promyelocytic leukemia; treatment related AML
Negative pregnancy test for female recipient
CMV seropositive
Live attenuated vaccines
DISEASE STATUS: Recipients to be enrolled are patients eligible for allogeneic HCT, who were diagnosed with hematologic cancers including:

Exclusion Criteria

Aplastic anemia
Planned CMV prophylactic therapy
There are ongoing non-hematological post-HCT toxicities >= grade 3 non-hematological (hem) adverse events (AE's), with exception of grade 3 glucose intolerance and grade 3 non-hem labs; cholesterol, triglyceride, and hyperglycemia
...
Aplastic anemia
Planned CMV prophylactic therapy
There are ongoing non-hematological post-HCT toxicities >= grade 3 non-hematological (hem) adverse events (AE's), with exception of grade 3 glucose intolerance and grade 3 non-hem labs; cholesterol, triglyceride, and hyperglycemia
POST-HCT STUDY-SPECIFIC EXCLUSIONS:
Planned immunosuppression with alemtuzumab or any equivalent in vivo T-cell depleting agent
Diagnosed with > grade 2 graft-versus-host disease (GVHD) before day 28 post-HCT, and diagnosed with > grade 2 GVHD between day 28 post-HCT and administration of the 2nd vaccine at day 56
Pregnant and/or breast feeding if a female recipient
Any prior investigational CMV vaccine
Experimental anti-CMV chemotherapy in the last 6 months
Refusing to use contraception up to 90 days post-HCT
Had relapse
Received antiviral treatment with GVC/VAL, FOS, Cidofovir, CMX-001 at any point during the 28 day period
Investigational research products or allergy treatment with antigens injections from 30 days prior to participation in the trial and up to 14 days after the second vaccination (day 70 post-HCT)
Experience graft failure (absolute neutrophil count < 500/mm^3)
Chronic myelogenous leukemia in blast crisis
In vitro T cell depleted graft
Live attenuated vaccines, medically indicated subunit or killed vaccines from 30 days prior to participation in the trial and up to 14 days after the second vaccination (day 70 post-HCT)
Planned prophylactic therapy with CMV immunoglobulin
Received steroid therapy with prednisone > 1 mg/kg/day, less than 7 days prior to injection
Multiple myeloma
Acute myeloid leukemia beyond second remission
Diagnosed with autoimmune disease

Summary

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

Inclusion Criteria

The use of alemtuzumab for immunosuppression is not permitted in this study
Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment is not allowed
Use of contraception up to 90 days post-HCT
...
The use of alemtuzumab for immunosuppression is not permitted in this study
Prophylactic therapy with CMV immunoglobulin or prophylactic antiviral CMV treatment is not allowed
Use of contraception up to 90 days post-HCT
HLA A*0201 subtype
Leukemia, not otherwise specified (NOS)
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
All subjects must have the ability to understand and the willingness to sign a written informed consent
Antiviral treatment for herpes simplex virus (HSV), human herpes virus 6 (HHV6), Epstein-Barr virus (EBV) and adenovirus including the use of GVC/VAL, FOS, Cidofovir, CMX-001 may also suppress reactivation of CMV, thus it will not be allowed in this study; patients requiring such treatment before randomization (day 28) will be removed from the study and replaced; reasons for removal will be reported in the patient's CRF
Chronic lymphoid leukemia; adult T cell leukemia/lymphoma, chronic lymphocytic leukemia not otherwise specified (NOS), hairy cell leukemia; prolymphocytic leukemia (B or T); T cell large granular (gran.) lymphocytic (lymph.) leukemia (leuk)
All medications, supportive care, blood products or radiation therapy taken or administered during the trial will be documented in the subject's clinical/hospital and case report form (CRF), using City of Hope (COH) guidelines; the subject's clinical information will be recorded on the appropriate CRF
Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and active hepatitis B virus (HBV) (surface antigen negative)
Chronic myeloproliferative disease (CML); chronic eosinophilic leukemia (CEL)/hypereosinophilic syndrome; chronic idiopathic myelofibrosis; CML - Philadelphia chromosome; essential thrombocythemia; polycythemia vera
Lymphoma, NOS
Planned related or unrelated HCT, with 8/8 or 7/8 (A, B, C, DRB1) high resolution HLA donor allele matching
Willingness to be followed for the planned duration of the trial (6 months post-HCT)
Myelodysplastic syndrome, NOS; chronic myelomonocytic leukemia
Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections)
Myeloma, NOS; monoclonal gammopathy of undetermined significance (MGUS); solitary plasmacytoma
All enrolled recipients who will require anti-CMV therapy before day 28 will be replaced, treated and monitored as required by COH standard of care; GVC/VAL, FOS, Cidofovir, CMX-001 may be used according to COH standard of care (SOC) for preemptive management of CMV viremia; should antiviral treatment be required after day 28, the planned 2nd vaccine injection at day 56 will not be administered (vaccine arm only)
Hodgkin lymphoma, NOS; Hodgkin lymphoma nodular lymphocyte predominant (LP), NOS; Hodgkin lymphoma - like post-transplant lymphoproliferative disorder (PTLD)
Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status needs to be in hematologic remission by bone marrow/peripheral blood; persistent lymphadenopathy on computed tomography [CT] or CT/positron emission tomography [PET] scan without progression is allowed)
Acute lymphoblastic leukemia (ALL); B-precursor ALL; T cell ALL
Able and willing to sign the informed consent form (ICF)
Hodgkin and non-Hodgkin lymphoma
Non-Hodgkin lymphoma (NHL); anaplastic large-cell lymphoma (ALCL), cutaneous, ALCL, systemic; Burkitt lymphoma/leukemia; cutaneous T-cell lymphoma (CTCL)/mycosis fungoides; CTCL/Sezary syndrome; diffuse large B-cell lymphoma; mucosa associated lymphoid tissue (MALT)-lymphoma; extranodal natural killer (NK)/T cell lymphoma, extranodal NK/T lymphoma nasal; follicular lymphoma; lymphoplasmacytic lymphoma mantle cell lymphoma; mediastinal large B-cell lymphoma; nodal marginal zone B-cell lymphoma (lymph.); NHL aggressive, NOS; NHL indolent, NOS; NHL, NOS; peripheral T cell lymphoma, NOS; PTLD (monoclonal); PTLD (polyclonal); precursor (precur.) B-lymphoblastic lymphoma; precur T-lymphoblastic lymphoma; primary central nervous system (CNS) lymphoma; primary effusion lymphoma; small lymphocytic lymphoma, NOS
Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase
Planned HCT with minimal to no-T cell depletion of graft
Myelodysplastic syndrome
Concurrent enrollment in other clinical trials using an investigational product is prohibited
Acute myeloid leukemia (AML), acute promyelocytic leukemia; treatment related AML
Negative pregnancy test for female recipient
CMV seropositive
Live attenuated vaccines
DISEASE STATUS: Recipients to be enrolled are patients eligible for allogeneic HCT, who were diagnosed with hematologic cancers including:

Exclusion Criteria

Aplastic anemia
Planned CMV prophylactic therapy
There are ongoing non-hematological post-HCT toxicities >= grade 3 non-hematological (hem) adverse events (AE's), with exception of grade 3 glucose intolerance and grade 3 non-hem labs; cholesterol, triglyceride, and hyperglycemia
...
Aplastic anemia
Planned CMV prophylactic therapy
There are ongoing non-hematological post-HCT toxicities >= grade 3 non-hematological (hem) adverse events (AE's), with exception of grade 3 glucose intolerance and grade 3 non-hem labs; cholesterol, triglyceride, and hyperglycemia
POST-HCT STUDY-SPECIFIC EXCLUSIONS:
Planned immunosuppression with alemtuzumab or any equivalent in vivo T-cell depleting agent
Diagnosed with > grade 2 graft-versus-host disease (GVHD) before day 28 post-HCT, and diagnosed with > grade 2 GVHD between day 28 post-HCT and administration of the 2nd vaccine at day 56
Pregnant and/or breast feeding if a female recipient
Any prior investigational CMV vaccine
Experimental anti-CMV chemotherapy in the last 6 months
Refusing to use contraception up to 90 days post-HCT
Had relapse
Received antiviral treatment with GVC/VAL, FOS, Cidofovir, CMX-001 at any point during the 28 day period
Investigational research products or allergy treatment with antigens injections from 30 days prior to participation in the trial and up to 14 days after the second vaccination (day 70 post-HCT)
Experience graft failure (absolute neutrophil count < 500/mm^3)
Chronic myelogenous leukemia in blast crisis
In vitro T cell depleted graft
Live attenuated vaccines, medically indicated subunit or killed vaccines from 30 days prior to participation in the trial and up to 14 days after the second vaccination (day 70 post-HCT)
Planned prophylactic therapy with CMV immunoglobulin
Received steroid therapy with prednisone > 1 mg/kg/day, less than 7 days prior to injection
Multiple myeloma
Acute myeloid leukemia beyond second remission
Diagnosed with autoimmune disease

Locations

Duarte, California, 91010
Duarte, California, 91010

Tracking Information

NCT #
NCT01588015
Collaborators
National Cancer Institute (NCI)
Investigators
  • Principal Investigator: Ryotaro Nakamura City of Hope Medical Center
  • Ryotaro Nakamura City of Hope Medical Center