Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445744
Status:
COMPLETED
Last Update Posted:
2018-01-02
First Post:
2007-03-07
Brief Title:
Cyclophosphamide and Busulfan Followed by Donor Stem Cell Transplant in Treating Patients With Myelofibrosis Acute Myeloid Leukemia or Myelodysplastic Syndrome
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Cyclophosphamide Followed by Intravenous Busulfan as Conditioning for Hematopoietic Cell Transplantation in Patients With Myelofibrosis Acute Myeloid Leukemia or Myelodysplastic Syndrome
Status:
COMPLETED
Status Verified Date:
2017-12
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:
This trial is studying the side effects and how well giving cyclophosphamide and busulfan followed by donor stem cell transplant works in treating patients with myelofibrosis acute myeloid leukemia or myelodysplastic syndrome Giving chemotherapy such as cyclophosphamide and busulfan before a donor stem cell transplant helps stops the growth of cancer cells It also helps stop the patients immune system from rejecting the donors stem cells The donated stem cells may replace the patients immune cells and help destroy any remaining cancer cells graft-versus-tumor effect Sometimes the transplanted cells from a donor can also make an immune response against the bodys normal cells Giving tacrolimus and methotrexate after the transplant may stop this from happening
Detailed Description:
PRIMARY OBJECTIVES
I To estimate the incidence of hepatotoxicity with a conditioning regimen of CY cyclophosphamidetBU busulfan in patients receiving hematopoietic cell transplant HCT
SECONDARY OBJECTIVES
I To determine overall and non-relapse mortality at day 200 after HCT
II To determine the peak bilirubin levels through day 20 after HCT
III To determine the incidence of pulmonary toxicity in the form of idiopathic pulmonary syndrome IPS
IV To determine the rate of graft failure
V To determine the time to engraftment
VI To determine the rate of relapse
VII To determine the incidence and severity of graft-versus-host disease GVHD
VIII To evaluate the pharmacokineticsdynamics of BU and CY
X To evaluate the pharmacogenomics of response toxicity and pharmacokinetics of CYtBU
OUTLINE
CONDITIONING REGIMEN Patients receive cyclophosphamide intravenously IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell transplant on day 0
POST-TRANSPLANT IMMUNOSUPPRESSION Patients receive tacrolimus IV or orally PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1 3 6 and 11
After completion of study treatment patients are followed periodically
I To estimate the incidence of hepatotoxicity with a conditioning regimen of CY cyclophosphamidetBU busulfan in patients receiving hematopoietic cell transplant HCT
SECONDARY OBJECTIVES
I To determine overall and non-relapse mortality at day 200 after HCT
II To determine the peak bilirubin levels through day 20 after HCT
III To determine the incidence of pulmonary toxicity in the form of idiopathic pulmonary syndrome IPS
IV To determine the rate of graft failure
V To determine the time to engraftment
VI To determine the rate of relapse
VII To determine the incidence and severity of graft-versus-host disease GVHD
VIII To evaluate the pharmacokineticsdynamics of BU and CY
X To evaluate the pharmacogenomics of response toxicity and pharmacokinetics of CYtBU
OUTLINE
CONDITIONING REGIMEN Patients receive cyclophosphamide intravenously IV on days -7 and -6 and busulfan IV over 3 hours on days -5 to -2
TRANSPLANTATION Patients undergo allogeneic peripheral blood stem cell transplant on day 0
POST-TRANSPLANT IMMUNOSUPPRESSION Patients receive tacrolimus IV or orally PO twice daily on days -1 to 200 with taper on day 56 and methotrexate on days 1 3 6 and 11
After completion of study treatment patients are followed periodically
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2010-00270 | REGISTRY | None | None |
| P01HL036444 | NIH | CTRP Clinical Trial Reporting Program | httpsreporternihgovquickSearchP01HL036444 |