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

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CXCR4 Waldenstrom’s Macroglobulinemia Study of Phosphatidylinositol-3-kinase (PI3K) Inhibitor Idelalisib (GS-1101) in Waldenström Macroglobulinemia Trial of Ixazomib, Dexamethasone and Rituximab in Patients With Untreated Waldenstrom’s Macroglobulinemia Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom’s Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing LBH589 in Relapsed or Relapsed and Refractory Waldenstrom’s Macroglobulinemia Everolimus, Bortezomib and/or Rituximab in Patients With Relapsed/Refractory Waldenstrom’s Macroglobulinemia A Phase II Trial of Ofatumumab in Subjects With Waldenstrom’s Macroglobulinemia Study of ABT-199 (GDC-199) In Patients With Relapsed Or Refractory Waldenström Macroglobulinemia Expression of Ku70/XRCC6 in Waldenström’s Macroglobulinemia Anti-Angiogenesis Therapy Using Thalidomide in Patients With Waldenstrom’s Macroglobulinemia Study of VTD in Waldenstrom’s Macroglobulinemia Dasatinib In Waldenström Macroglobulinemia The Comparison of RCD Versus BCD in Newly Diagnosed Waldenström Macroglobulinemia CC-5013 (Lenalidomide) and Rituximab in Waldenstrom’s Macroglobulinemia Combination Bortezomib and Rituximab in Patients With Waldenstrom’s Macroglobulinemia R-VRD Followed by Lenalidomide Maintenance in Patients With Waldenstrom’s Macroglobulinemia Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom’s Macroglobulinemia Antineoplaston Therapy in Treating Patients With Recurrent or Refractory Waldenstrom’s Macroglobulinemia Efficacy of First Line B-RI for Treatment Naive Waldenström’s Macroglobulinemia Sildenafil Citrate in Waldenstrom’s Macroglobulinemia Bortezomib (Velcade) in Waldenstrom’s Macroglobulinemia Phase II Study of Campath-1H Antibody to Treat Waldenstrom’s Macroglobulinemia

Brief Title

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

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

Brief 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.
    

Detailed 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 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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Immunogenicity evaluated by monitoring CMV-specific CD8+ T cells by multi color flow cytometric analyses

Condition

Accelerated Phase Chronic Myelogenous Leukemia

Intervention

tetanus-CMV fusion peptide vaccine

Study Arms / Comparison Groups

 Arm I (vaccine therapy)
Description:  Patients receive Tet-CMV + PF03512675 SC on days 28 and 56 post-HCT.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

36

Start Date

October 29, 2012

Completion Date

November 30, 2021

Primary Completion Date

November 30, 2021

Eligibility Criteria

        Inclusion Criteria:

          -  HLA A*0201 subtype

          -  CMV seropositive

          -  Able and willing to sign the informed consent form (ICF)

          -  Willingness to be followed for the planned duration of the trial (6 months post-HCT)

          -  Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and
             active hepatitis B virus (HBV) (surface antigen negative)

          -  Planned related or unrelated HCT, with 8/8 or 7/8 (A, B, C, DRB1) high resolution HLA
             donor allele matching

          -  HCT for the treatment of hematologic cancers including, but not limited to:

               -  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)

               -  Chronic myelogenous leukemia in first chronic or accelerated phase, or in second
                  chronic phase

               -  Hodgkin and non-Hodgkin lymphoma

               -  Myelodysplastic syndrome

          -  Planned HCT with minimal to no-T cell depletion of graft

          -  Use of contraception up to 90 days post-HCT

          -  Negative pregnancy test for female recipient

          -  DISEASE STATUS: Recipients to be enrolled are patients eligible for allogeneic HCT,
             who were diagnosed with hematologic cancers including:

          -  Acute lymphoblastic leukemia (ALL); B-precursor ALL; T cell ALL

          -  Acute myeloid leukemia (AML), acute promyelocytic leukemia; treatment related AML

          -  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)

          -  Chronic myeloproliferative disease (CML); chronic eosinophilic leukemia
             (CEL)/hypereosinophilic syndrome; chronic idiopathic myelofibrosis; CML - Philadelphia
             chromosome; essential thrombocythemia; polycythemia vera

          -  Leukemia, not otherwise specified (NOS)

          -  Myelodysplastic syndrome, NOS; chronic myelomonocytic leukemia

          -  Hodgkin lymphoma, NOS; Hodgkin lymphoma nodular lymphocyte predominant (LP), NOS;
             Hodgkin lymphoma - like post-transplant lymphoproliferative disorder (PTLD)

          -  Lymphoma, NOS

          -  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

          -  Myeloma, NOS; monoclonal gammopathy of undetermined significance (MGUS); solitary
             plasmacytoma

          -  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 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

          -  Concurrent enrollment in other clinical trials using an investigational product is
             prohibited

          -  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

          -  Medications that might interfere with the evaluation of the investigational product
             should not be administered, from 30 days prior to participation on the trial and up to
             14 days after the second vaccination (day 70 post-HCT); medications in this category
             include, but are not limited to:

               -  Live attenuated vaccines

               -  Medically indicated subunit (Engerix-B for HBV; Gardasil for HPV) or killed
                  vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen
                  injections)

          -  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

          -  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)

          -  All subjects must have the ability to understand and the willingness to sign a written
             informed consent

        Exclusion Criteria:

          -  A poor-risk patient, as defined by any of the following:

               -  Chronic myelogenous leukemia in blast crisis

               -  Acute myeloid leukemia beyond second remission

               -  Multiple myeloma

               -  Aplastic anemia

          -  Planned immunosuppression with alemtuzumab or any equivalent in vivo T-cell depleting
             agent

          -  In vitro T cell depleted graft

          -  Planned prophylactic therapy with CMV immunoglobulin

          -  Planned CMV prophylactic therapy

          -  Experimental anti-CMV chemotherapy in the last 6 months

          -  Diagnosed with autoimmune disease

          -  Receipt of the following substances:

               -  Any prior investigational CMV vaccine

               -  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)

               -  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)

          -  Pregnant and/or breast feeding if a female recipient

          -  Refusing to use contraception up to 90 days post-HCT

          -  POST-HCT STUDY-SPECIFIC EXCLUSIONS:

          -  On days 28 and 56 post-HCT (immunization day for the vaccine arm) all study recipients
             (vaccine and observation arms) will be reviewed for eligibility and ruled ineligible
             to initiate or continue in the study and receive vaccination (for the vaccine arm) if:

               -  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

               -  Received steroid therapy with prednisone > 1 mg/kg/day, less than 7 days prior to
                  injection

               -  Had relapse

               -  Experience graft failure (absolute neutrophil count < 500/mm^3)

               -  Received antiviral treatment with GVC/VAL, FOS, Cidofovir, CMX-001 at any point
                  during the 28 day period

               -  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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Ryotaro Nakamura, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01588015

Organization ID

12022

Secondary IDs

NCI-2012-00589

Responsible Party

Sponsor

Study Sponsor

City of Hope Medical Center

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Ryotaro Nakamura, Principal Investigator, City of Hope Medical Center


Verification Date

June 2021