Clinical trial NCT01903928: A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant
Official title: An Open Phase 2 Trial to Evaluate Safety of a Therapeutic Vaccine, ASP0113, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allogeneic Hematopoietic Cell Transplant
Keywords: cytomegalovirus
HCT
DNA vaccine
transplantation
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2013-07-19
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to evaluate safety and tolerability of a therapeutic vaccine, ASP0113, in subjects undergoing allogeneic HCT. The occurrence of CMV viremia and immunogenicity are also assessed.


Eligibility criteria: Inclusion Criteria:

* Subject is planned to undergo either of the following:

  * Sibling Donor Transplant - 7/8 Human Leukocyte Antigen (HLA)-A, -B, -C, -DRß1 match utilizing high resolution typing or 8/8 (HLA)-A, -B, -C, -DRß1 match utilizing low or high resolution typing.
  * Unrelated Donor Transplant - 7/8 or 8/8 HLA-A, -B, -C, -DRß1 match utilizing high resolution typing.
* Subject has one of the following underlying diseases: Acute myeloid leukemia (AML) /Acute lymphoblastic leukemia (ALL) / Acute undifferentiated leukemia (AUL) /Acute biphenotypic leukemia / Chronic myelogenous leukemia (CML) / Chronic lymphocytic leukemia (CLL) / myelodysplastic syndrome(s) (MDS)
* Subject is scheduled to receive an allogeneic peripheral blood stem cell (PBSC) or bone marrow transplant (BMT) for the treatment of hematologic disorders

Exclusion Criteria:

* Subject has active CMV disease or infection or has received treatment for active CMV disease or infection within 90 days prior to transplant
* Subject has planned CMV prophylactic therapy with antiviral drugs or CMV-specific immunoglobulins
* Subject has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score \> 3
* Subject is known to be positive for human immunodeficiency virus (HIV), hepatitis B surface antigen or hepatitis C ribonucleic acid (RNA)
* Subject has received any of the following substances or treatments:

  * T-cell depletion of donor cell product.
  * Alemtuzumab within 60 days prior to transplant, including conditioning regimen. Subjects for whom treatment with alemtuzumab is planned at any time from 60 days prior to through one year post-transplant should not be enrolled in the trial.
  * Administration of a CMV vaccine, including any prior exposure to ASP0113.
* Subject has received an allogeneic stem cell transplant within one year prior to transplant
* Subject has a current malignancy in addition to the malignancy being treated for the study or the subject has a history of any other malignancy
* Subject has an unstable medical or psychiatric condition, including a history of illicit drug(s) or alcohol abuse that the Investigator believes will interfere with protocol requirements.

Primary outcomes:
measure: Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests
timeFrame: for 365 days after HCT
Secondary outcomes:
measure: Local reactogenicity
timeFrame: for 14 days following each injection
measure: Incidence of CMV viremia
timeFrame: for 365 days after HCT
measure: CMV-specified antiviral therapy
timeFrame: for 365 days after HCT
measure: Incidence of cytomegalovirus end-organ disease (CMV EOD)
timeFrame: for 365 days after HCT
measure: Maximum grade of Graft Versus Host Disease (GVHD)
timeFrame: for 365 days after HCT
Other outcomes:
Locations:
city: Kantou
country: Japan
city: Kyushu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Mori T, Kanda Y, Takenaka K, Okamoto S, Kato J, Kanda J, Yoshimoto G, Gondo H, Doi S, Inaba M, Kodera Y. Safety of ASP0113, a cytomegalovirus DNA vaccine, in recipients undergoing allogeneic hematopoietic cell transplantation: an open-label phase 2 trial. Int J Hematol. 2017 Feb;105(2):206-212. doi: 10.1007/s12185-016-2110-3. Epub 2016 Oct 28.