Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic … (NCT02396134) | Clinical Trial Compass
CompletedPhase 2
Vaccine Therapy in Reducing the Frequency of Cytomegalovirus Events in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant
United States61 participantsStarted 2015-05-21
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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)-base…