A Study to Evaluate Safety and Tolerability of a Therapeutic Vaccine, ASP0113, in Subjects Undergoing Allogeneic Hematopoietic Cell Transplant

NCT01903928 | Completed Phase 2 DMC

• 1 other identifier: 0113-CL-1003
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

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.

Conditions

Allogeneic Hematopoietic Cell Transplant

Keywords

cytomegalovirus; HCT; DNA vaccine; transplantation

Outcome Measures

Primary Outcomes (1)

• Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests

  for 365 days after HCT

Secondary Outcomes (5)

• Local reactogenicity

  for 14 days following each injection

• Incidence of CMV viremia

  for 365 days after HCT

• CMV-specified antiviral therapy

  for 365 days after HCT

• Incidence of cytomegalovirus end-organ disease (CMV EOD)

  for 365 days after HCT

• Maximum grade of Graft Versus Host Disease (GVHD)

  for 365 days after HCT

Study Arms (1)

ASP0113 group

EXPERIMENTAL

Participants receive 1 mL of ASP0113 intramuscularly 5 times, on days -14 to -3, 14 to 40, 60 ± 5, 90 ± 10, and 180 ± 10, counting from the transplantation (stem cell transfusion) day (day 0)

Biological: ASP0113

Interventions

ASP0113 BIOLOGICAL

injection

ASP0113 group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (2)

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Related Publications (1)

• 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.

  PMID: 27796740 DERIVED

Related Links

• Link to results on the Astellas Clinical Study Results website

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 19, 2013
• Study Start: June 20, 2013
• Primary Completion: January 19, 2015
• Study Completion: January 19, 2015
• Last Updated: October 17, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

JP (2)