OHSU

IRB #

IRB00009894

Title

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial to Evaluate the Protective Efficacy and Safety of a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

Principal Investigator

Morgan Hakki

Study Purpose

The purpose of this study is to find out if the study vaccine (ASP0113) can prevent cytomegalovirus (CMV) infections in stem cell transplant patients. We also want to find out if the study vaccine is safe, and see what effects, good and/or bad, it has on the participants and their cancer.

Medical Condition(s)

CMV infection in patients undergoing a donor stem cell transplant

Eligibility Criteria

-Age 18 or older
-Patients who are planned to undergo a donor blood stem cell transplant for certain blood cancers. The investigator will help determine whether a patient's disease qualifies.
-Positive for CMV as determined by a specific test. (However, patients with an active CMV infection for which they are receiving treatment are not eligible.) The investigator will determine this.
-Other criteria as determined by the investigator

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive the study vaccine 5 times over a 6-month time period. After they are finished taking the study vaccine, they must return to OHSU for follow-up exams for another 6 months. After this time, study staff will keep track of participants' medical condition for another 4.5 years. This could be done via phone calls, office visits, letters, or collection of participant's medical records from other facilities.

Minors Included

No

Contact

Nan Subbiah 503-494-4603
Chelsea Kline 503-418-0128

Sponsor

Astellas Pharma Global Development, Inc

Recruitment End

01/01/2016

Compensation Provided

No


Go Back