Study of Opebacan in Patients Undergoing Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Stopped early · Phase 1/Phase 2
Conditions studied: Graft Versus Host Disease
In brief
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 determine the pharmacokinetics of opebacan in subjects undergoing myeloablative allogeneic Hematopoietic Stem Cell Transplantation To determine if IV administration of opebacan is associated with changes in biological markers for inflammation To develop preliminary descriptive data on the occurrence and severity of Hematopoietic Stem Cell Transplantation related complications, including aGvHD
Key facts
- Study ID
- NCT00454155
- Run by
- XOMA (US) LLC
- People needed
- 6
- Starts
- 2007-02-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2012-07-30
Who can join
Age: any, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Study site — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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