Ignite Creation Date:
2024-05-05 @ 4:59 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00361140
Status:
COMPLETED
Last Update Posted:
2017-03-03
First Post:
2006-08-03
Brief Title:
Busulfan SafetyEfficacy as Conditioning Prior to Hematopoietic Cell Transplantation HCT
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Busulfan Dose Escalation Study Based on AUC in the Setting of BusulfanFludarabine Conditioning Prior to Allogeneic Hematopoietic Cell Transplantation HCT
Status:
COMPLETED
Status Verified Date:
2013-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6 -5 -4 and -3 Daily treatment doses will be adjusted to achieve target area under the plasma concentration time curve AUC Day 0 is the day of hematopoietic progenitor cell reinfusion Supportive care will be based on institutional guidelines Blood samples will be collected for dose modification based on the AUC levels Dose escalation will proceed to determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit of higher doses of busulfan
Detailed Description:
Patients will receive anti-seizure prophylaxis beginning on day -7 Pre-transplant conditioning will include Fludarabine and dose-escalated Busulfan on days -6 -5 -4 and -3 Daily treatment doses will be adjusted to achieve target AUCs area under the plasma concentration time curve Day 0 is the day of hematopoietic progenitor cell reinfusion
Supportive care will be based on institutional guidelines In an effort to prevent hepatotoxicity ursodiol will be given to patients During chemotherapy patients will not receive concurrent metronidazole itraconazole or be given acetaminophen
Blood samples will be collected at specific times after Dose 1 and Dose 4 and dose modification will be determined or based on the desired AUC levels Doses 3 andor 4 will be adjusted to achieve an average daily Busulfan AUC over the 4 treatment days
Dose escalation will proceed through 3 dose levels to determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit of higher doses of busulfan
Graft assessment processing and characterization will be done as per institutional guidelines Donor-recipient chimerism two genetically distinct types of blood cells will be characterized by samples obtained pre-transplant and on days 30- 7 90-7 and 360-30 post-transplant
Supportive care will be based on institutional guidelines In an effort to prevent hepatotoxicity ursodiol will be given to patients During chemotherapy patients will not receive concurrent metronidazole itraconazole or be given acetaminophen
Blood samples will be collected at specific times after Dose 1 and Dose 4 and dose modification will be determined or based on the desired AUC levels Doses 3 andor 4 will be adjusted to achieve an average daily Busulfan AUC over the 4 treatment days
Dose escalation will proceed through 3 dose levels to determine the maximally tolerated level or AUC to evaluate the potential therapeutic benefit of higher doses of busulfan
Graft assessment processing and characterization will be done as per institutional guidelines Donor-recipient chimerism two genetically distinct types of blood cells will be characterized by samples obtained pre-transplant and on days 30- 7 90-7 and 360-30 post-transplant
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