A Study of the Safety and Efficacy of CMX001 for the Prevention of Cytomegalovirus (CMV) Infection in CMV-seropositive (R+) Hematopoietic Stem Cell Transplant Recipients

Status: Recruiting
Phase: Phase 3
Diagnosis: Hematopoietic Stem Cell Transplant
NCT ID: NCT01769170 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID:

 

The purpose of this study is to compare the effectiveness of CMX001 to placebo for the prevention of CMV infection in stem cell transplant patient who do not have CMV before starting treatment with CMX001.

 

Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center

Overall PI:
Francisco Marty, MD, Brigham and Women's Hospital

Site-responsible Investigators:
James Levine, MD, Beth Israel Deaconess Medical Center

Contacts:
Dana-Farber Cancer Institute: Mildred Pasek, mpasek@partners.org
Beth-Israel Deaconess Medical Center: Cancer Trials Call Center, 617-667-3060

Eligibility Criteria

Inclusion Criteria: - Subjects will be adult allogeneic HSCT recipients aged ≥ 18 years-old (or as applicable, per local law) who were CMV seropositive before transplantation and are CMV viremia negative posttransplant. Exclusion Criteria: - Subjects who have a positive CMV viremia test at any time between transplant and the First Dose Day (FDD). - Subjects with hypersensitivity (not renal dysfunction or eye disorder) to CDV or to CMX001 or its excipients. - Subjects who have received any anti-CMV therapy and investigational anti-CMV drugs at any time posttransplant. - Subjects who have had any anti-CMV vaccine at any time.
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