drugset / Trial / NCT01588015
Vaccine Therapy in Preventing Cytomegalovirus Infection in Patients With Hematological Malignancies Undergoing Donor Stem Cell Transplant
RandomizedParallel-groupOpen-labelSupportive care
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.
Timeline
- Start
- 2012-10-29
- Primary completion
- 2024-02-02
- Completion
- 2024-02-02
Publications
- La Rosa C, Longmate J, Lingaraju CR, Zhou Q, Kaltcheva T, Hardwick N, Aldoss I, Nakamura R, Diamond DJ. Rapid Acquisition of Cytomegalovirus-Specific T Cells with a Differentiated Phenotype, in Nonviremic Hematopoietic Stem Transplant Recipients Vaccinated with CMVPepVax. Biol Blood Marrow Transplant. 2019 Apr;25(4):771-784. doi: 10.1016/j.bbmt.2018.12.070. Epub 2018 Dec 16.
- Nakamura R, La Rosa C, Longmate J, Drake J, Slape C, Zhou Q, Lampa MG, O'Donnell M, Cai JL, Farol L, Salhotra A, Snyder DS, Aldoss I, Forman SJ, Miller JS, Zaia JA, Diamond DJ. Viraemia, immunogenicity, and survival outcomes of cytomegalovirus chimeric epitope vaccine supplemented with PF03512676 (CMVPepVax) in allogeneic haemopoietic stem-cell transplantation: randomised phase 1b trial. Lancet Haematol. 2016 Feb;3(2):e87-98. doi: 10.1016/S2352-3026(15)00246-X. Epub 2015 Dec 24.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CMVPepVax | Unknown | 2.5 mg | Subcutaneous |
| Subject | agatolimod | Oligonucleotide (other) | 1 mg | Subcutaneous |
Indications
B-cell adult acute lymphocytic leukemia
Burkitt lymphoma
MALT lymphoma
T-cell adult acute lymphocytic leukemia
T-cell large granular lymphocyte leukemia
Waldenstrom macroglobulinemia
acquired polycythemia vera
acute myeloid leukemia with 11q23 abnormalities
acute myeloid leukemia with t(8;21)(q22;q22) translocation
acute myeloid leukemia, inv(16)(p13.1;q22)
acute myeloid leukemia, t(16;16)(p13.1;q22)
acute promyelocytic leukemia
adult T-cell leukemia/lymphoma
adult nodular lymphocyte predominant Hodgkin lymphoma
anaplastic large cell lymphoma
central nervous system non-hodgkin lymphoma
chronic eosinophilic leukemia
chronic lymphocytic leukemia/small lymphocytic lymphoma
chronic myelomonocytic leukemia
cytomegalovirus infection
diffuse large B-cell lymphoma
essential thrombocythemia
extramedullary plasmacytoma
extranodal nasal NK/T cell lymphoma
leukemia, myeloid, accelerated-phase
mantle cell lymphoma
monoclonal gammopathy of uncertain significance
mycosis fungoides and variants
myelodysplastic syndrome
nodal marginal zone B-cell lymphoma
peripheral T-cell lymphoma, not otherwise specified
plasma cell myeloma
post-transplant lymphoproliferative disease
primary myelofibrosis
primary plasmacytoma of the bone
prolymphocytic leukemia
refractory hairy cell leukemia
refractory plasma cell neoplasm