Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignanci… (NCT01588015) | Clinical Trial Compass
CompletedPhase 1
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
United States36 participantsStarted 2012-10-29
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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
* Chroni…
What they're measuring
1
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