Ignite Creation Date:
2024-05-05 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00363467
Status:
TERMINATED
Last Update Posted:
2017-03-23
First Post:
2006-08-10
Brief Title:
Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Pilot Study of Intravenous Targeted-Dose Busulfan Monotherapy as Conditioning for Autologous Hematopoietic Progenitor Cell Transplantation in High-Risk AML
Status:
TERMINATED
Status Verified Date:
2011-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
During the pre-transplantation phase following completion of consolidation chemotherapy patients will begin to receive G-CSF at 10 mcgkg twice daily leukapheresis will also be given until a target goal for recipient body weight is obtained or up to a maximum of 5 days ConditioningPreparative therapy will follow PBSC collection for up to 30 days with Busulfan IV daily x 4 days subsequent doses will be adjusted based on pharmacokinetic plasma levelmonitoring Following 1 day of rest stem cell reinfusion will begin with supportive care During follow-up patients will be monitored out to 730 days
Detailed Description:
1 Pre- Transplantation Phase -
1 Twenty-four to 48 hours following completion of consolidation chemotherapy patients will begin to receive G-CSF at 10 mcgkg twice daily subcutaneously Alternatively patients may receive G-CSF alone same dose as mobilization therapy
2 Leukapheresis will begin day 4 of G-CSF administration and proceed according to institutional guidelines Leukapheresis will continue until a target goal for recipient body weight is obtained or up to a maximum of 5 days A minimum recipient body weight is required to proceed to transplantation
2 Transplantation Phase
a ConditioningPreparative therapy - up to 30 days following PBSC collection patients will begin conditioning therapy with Busulfan IV daily x 4 days transplantation days -5-4-3-2 The day -5 and -4 dose will be 130mgm2 subsequent doses will be adjusted based on pharmacokinetic monitoring
Busulfan plasma level monitoring collected around the first dose of busulfan b Stem cell reinfusion - following 1 day of rest previously collected autologous peripheral blood stem cells will be infused
The administration of supportive measures eg intravenous fluids antihistamines during stem cell reinfusion will be performed according to institutional guidelines
3 Supportive care
1 Antibiotic prophylaxis- according to hospitalinstitutional guidelines and at the discretion of the treating physician
2 Growth factor support
3 Transfusion support
4 Prophylaxis for busulfan-induced seizures
4 During follow-up patients will be seen at least weekly for the first month and there after periodically out to 730 days posttransplant The following medical procedures will be done
Medical history and physical exam including concurrent meds vital signs performance status and weight
Standard labs
Bone marrow aspirate and biopsy
1 Twenty-four to 48 hours following completion of consolidation chemotherapy patients will begin to receive G-CSF at 10 mcgkg twice daily subcutaneously Alternatively patients may receive G-CSF alone same dose as mobilization therapy
2 Leukapheresis will begin day 4 of G-CSF administration and proceed according to institutional guidelines Leukapheresis will continue until a target goal for recipient body weight is obtained or up to a maximum of 5 days A minimum recipient body weight is required to proceed to transplantation
2 Transplantation Phase
a ConditioningPreparative therapy - up to 30 days following PBSC collection patients will begin conditioning therapy with Busulfan IV daily x 4 days transplantation days -5-4-3-2 The day -5 and -4 dose will be 130mgm2 subsequent doses will be adjusted based on pharmacokinetic monitoring
Busulfan plasma level monitoring collected around the first dose of busulfan b Stem cell reinfusion - following 1 day of rest previously collected autologous peripheral blood stem cells will be infused
The administration of supportive measures eg intravenous fluids antihistamines during stem cell reinfusion will be performed according to institutional guidelines
3 Supportive care
1 Antibiotic prophylaxis- according to hospitalinstitutional guidelines and at the discretion of the treating physician
2 Growth factor support
3 Transfusion support
4 Prophylaxis for busulfan-induced seizures
4 During follow-up patients will be seen at least weekly for the first month and there after periodically out to 730 days posttransplant The following medical procedures will be done
Medical history and physical exam including concurrent meds vital signs performance status and weight
Standard labs
Bone marrow aspirate and biopsy
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