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

Allogeneic Hematopoietic Cell Transplant Clinical Trial

Official title:

An Open Phase 2 Trial to Evaluate Safety of a Therapeutic Vaccine, ASP0113, in Recipients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01903928
• Other study ID #: 0113-CL-1003
• Status: Completed
• Phase: Phase 2
• Start date: June 20, 2013
• Est. completion date: January 19, 2015

Study information

• Verified date: January 2019
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: January 19, 2015
• Est. primary completion date: January 19, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Allogeneic Hematopoietic Cell Transplant

Intervention

Biological:
• ASP0113
injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety assessed by the incidence of adverse events, vital signs, physical exam and labo-tests		for 365 days after HCT
Secondary	Local reactogenicity	protocol-specified reactogenicity scale	for 14 days following each injection
Secondary	Incidence of CMV viremia	CMV plasma viral load = 1000 copies	for 365 days after HCT
Secondary	CMV-specified antiviral therapy	CMV-specific AVT(Anti-virus therapy) initiated for a CMV plasma viral load = 1000 copies	for 365 days after HCT
Secondary	Incidence of cytomegalovirus end-organ disease (CMV EOD)	CMV pneumonia, CMV gastroenteritis, CMV hepatitis, et al	for 365 days after HCT
Secondary	Maximum grade of Graft Versus Host Disease (GVHD)		for 365 days after HCT

External Links

•   Link to results on the Astellas Clinical Study Results website