Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
Condition: Accelerated Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Adult Acute Lymphoblastic Leukemia in Remission; Adult Acute Myeloid Leukemia in Remission; Adult Hodgkin Lymphoma; Adult Non-Hodgkin Lymphoma; Chronic Phase Chronic Myelogenous Leukemia, BCR-ABL1 Positive; Cytomegaloviral Infection; Hematopoietic and Lymphoid Cell Neoplasm; HLA-A*0201 Positive Cells Present; Myelodysplastic Syndrome; Adult Lymphoblastic Lymphoma; Chronic Lymphocytic Leukemia; Myelofibrosis; Myeloproliferative Neoplasm
MeSH terms: Cytomegalovirus Infections; Lymphoma; Leukemia; Neoplasms; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphocytic, Chronic, B-Cell; Hodgkin Disease; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase; Leukemia, Myeloid, Accelerated Phase; Myelodysplastic Syndromes; Myeloproliferative Disorders
Intervention: CMVpp65-A*0201 peptide vaccine; Placebo; Laboratory Biomarker Analysis
Intervention description: Given SC; Given SC; Correlative studies
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well vaccine therapy works in reducing the
      frequency of cytomegalovirus severe infections (events) in patients with hematologic
      malignancies undergoing donor stem cell transplant. Vaccines made from a peptide may help the
      body build an effective immune response and may reduce cytomegalovirus events after donor
      stem cell transplant.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All subjects must have the ability to understand and the willingness to sign a written
             informed consent

          -  Participant must be willing to comply with study and/or follow-up procedures,
             including willingness to be followed for one year post-HCT

          -  Planned HCT for the treatment of the following hematologic malignancies:

               -  Lymphoma (Hodgkin and non-Hodgkin)

               -  Myelodysplastic syndrome

               -  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 and peripheral blood; persistent
                  lymphadenopathy on computed tomography [CT] or CT/positron emission tomography
                  [PET] scan without progression is allowed)

               -  Acute myeloid leukemia in first or second remission

               -  Chronic myelogenous leukemia in first chronic or accelerated phase, or in second
                  chronic phase

               -  Other hematologic malignancies including chronic lymphocytic leukemia,
                  myeloproliferative disorders and myelofibrosis; patients with multiple myeloma
                  and those with non-malignant disease such as aplastic anemia are excluded

          -  HLA A*0201 High resolution, 4-digit typing is required at HLA-A2 to ensure A*0201
             status.

          -  CMV seropositive (recipient)

          -  Planned related or unrelated HCT, with HLA donor allele matching; related donor must
             be an 8/8 match for HLA-A, -B, and -C at intermediate (or higher) resolution, and
             -DRB1 at high resolution using deoxyribonucleic acid (DNA)-based typing; unrelated
             donor must be an 8/8 match at HLA-A, -B, -C, and -DRB1 at high resolution using
             DNA-based typing; patients undergoing a second allo HCT are not eligible (patients who
             have undergone a previous autologous HCT are eligible)

          -  Planned HCT with no ex-vivo T cell depletion of graft; conditioning and
             immunosuppressive regimens according to institutional guidelines are permitted

          -  Negative serum or urine beta-human chorionic gonadotropin (HCG) test (female patient
             of childbearing potential only) within two weeks of registration

          -  Seronegative for human immunodeficiency virus (HIV), hepatitis C virus (HCV) and
             active hepatitis B virus (HBV) (surface antigen negative) within 2 months of
             registration

          -  Agreement by females of childbearing potential and sexually active males to use an
             effective method of contraception (hormonal or barrier method of birth control or
             abstinence) prior to study entry and for up to 90 days post-HCT; should a woman become
             pregnant or suspect that she is pregnant while participating on the trial, she should
             inform her treating physician immediately

        Exclusion Criteria:

          -  Any prior investigational CMV vaccine

          -  Experimental anti-CMV chemotherapy in the last 6 months

          -  Planned medications from the time of HCT to day 70 post-HCT:

               -  Live attenuated vaccines

               -  Medically indicated subunit (Engerix-B for HBV; Gardasil for human papilloma
                  virus [HPV]) or killed vaccines (e.g. influenza, pneumococcal, or allergy
                  treatment with antigen injections)

               -  Allergy treatment with antigens injections

               -  Alemtuzumab or any equivalent in vivo T-cell depleting agent; this includes
                  anti-thymocyte globulin (ATG) and post-transplant cyclophosphamide

               -  Antiviral medications with known therapeutic effects against CMV such as
                  ganciclovir (GCV)/valine (VAL), foscarnet (FOS), cidofovir,
                  hexadecyloxypropyl-cidofovir (CMX-001) and maribavir; acyclovir has no
                  therapeutic efficacy against CMV and is allowable as standard of care to prevent
                  herpes simplex virus (HSV)

               -  Other investigational product - concurrent enrollment in other clinical trials
                  using an investigational product is prohibited

               -  Other medications that might interfere with the evaluation of the investigational
                  product

          -  Patients with active autoimmune conditions requiring systemic immunosuppressive
             therapy within the previous 5 years are not eligible

          -  Pregnant women and women who are lactating; breastfeeding should be discontinued if
             the mother is enrolled on this study

          -  Any other condition that would, in the investigator's judgment, contraindicate the
             patient's participation in the clinical study due to safety concerns or compliance
             with clinical study procedures, e.g., social/psychological issues, etc

          -  Prospective participants who, in the opinion of the investigator, may not be able to
             comply with all study procedures (including compliance issues related to
             feasibility/logistics)