Status:
TERMINATED
Study of Opebacan in Patients Undergoing Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Lead Sponsor:
XOMA (US) LLC
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE1
PHASE2
Brief Summary
The objectives of this study are as follows: To demonstrate the safety of escalating doses of opebacan in subjects undergoing myeloablative allogeneic Hematopoietic Stem Cell Transplantation To dete...
Detailed Description
IV infusion of opebacan to replace endogenous BPI during the peritransplant period will result in the reduction of LPS-induced inflammatory sequelae, in particular aGvHD, in patients undergoing alloge...
Eligibility Criteria
Inclusion
- Age \<= 60 and undergoing allogeneic HSCT
- Life expectancy \> 8 weeks
- Scheduled for treatment with a conditioning regimen intended to be myeloablative
- Female subjects of child-bearing age must have a negative urine pregnancy test. Sexually active male and female subjects of reproductive age must be using a form of contraception considered effective and medically acceptable by the Investigator.
Exclusion
- Cumulative lifetime exposure of \> 300 mg/M2 of anthracycline (expressed as doxorubicin equivalent dose) or receipt of anthracycline within 180 days prior to initiating conditioning for HSCT
- Active infection
- Prophylactic antibacterial antibiotics.
- Positive for HIV, HTLV-I, or HTLV-II
- Any prior stem cell transplant
- Prior history of CHF
- Cord blood is the source of a subject's transplanted cells.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00454155
Start Date
February 1 2007
End Date
June 1 2010
Last Update
July 30 2012
Active Locations (1)
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1
Boston, Massachusetts, United States