Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454155
Status:
TERMINATED
Last Update Posted:
2012-07-30
First Post:
2007-03-28
Brief Title:
Study of Opebacan in Patients Undergoing Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation HSCT
Sponsor:
XOMA US LLC
Organization:
XOMA US LLC
Study Overview
Official Title:
A Phase III Study of the Safety and Pharmacokinetics of Opebacan rBPI21 in Patients Undergoing Myeloablative Allogeneic Hematopoietic Stem Cell Transplantation HSCT
Status:
TERMINATED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HSCT
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 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
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
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 allogeneic HSCT
The rationale for using opebacan in patients undergoing myeloablative regimens and HSCT is based on the following
Endotoxemia has been demonstrated to play a central pathophysiologic role as a trigger of aGvHD in animal models
Endotoxemia following HSCT is associated with inflammatory conditions such as inflammatory cytokine release that have been demonstrated in humans to be associated with organ damage and increased morbidity and mortality
Endotoxemia and LBP elevation have been demonstrated in humans undergoing ablative HSCT
Chemotherapy-induced neutropenia results in a deficiency of endogenous BPI levels
The timing of the endotoxemic insult is predictable ie subsequent to myeloablative chemotherapy and radiotherapy
The return to normal neutrophil levels is not immediate and takes one week to several weeks
Well established laboratory techniques for surrogate markers related to LPS presence and its activities can facilitate the evaluation of molecules designed to inhibit or antagonize LPS and its effects
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
The rationale for using opebacan in patients undergoing myeloablative regimens and HSCT is based on the following
Endotoxemia has been demonstrated to play a central pathophysiologic role as a trigger of aGvHD in animal models
Endotoxemia following HSCT is associated with inflammatory conditions such as inflammatory cytokine release that have been demonstrated in humans to be associated with organ damage and increased morbidity and mortality
Endotoxemia and LBP elevation have been demonstrated in humans undergoing ablative HSCT
Chemotherapy-induced neutropenia results in a deficiency of endogenous BPI levels
The timing of the endotoxemic insult is predictable ie subsequent to myeloablative chemotherapy and radiotherapy
The return to normal neutrophil levels is not immediate and takes one week to several weeks
Well established laboratory techniques for surrogate markers related to LPS presence and its activities can facilitate the evaluation of molecules designed to inhibit or antagonize LPS and its effects
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None