Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004899
Status:
COMPLETED
Last Update Posted:
2012-06-12
First Post:
2000-03-07
Brief Title:
Chemotherapy Plus Bone Marrow Transplantation and Filgrastim in Treating Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Autologous Bone Marrow Transplantation for Patients With Acute Myelogenous Leukemia or Myelodysplastic Syndrome - A Phase II Pilot Study
Status:
COMPLETED
Status Verified Date:
2012-06
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:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing and die Bone marrow transplantation may be able to replace cells that were destroyed by chemotherapy Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus bone marrow transplantation and filgrastim in treating patients who have acute myelogenous leukemia or myelodysplastic syndrome
PURPOSE Phase II trial to study the effectiveness of chemotherapy plus bone marrow transplantation and filgrastim in treating patients who have acute myelogenous leukemia or myelodysplastic syndrome
Detailed Description:
OBJECTIVES
Determine the overall survival and disease free survival of patients with acute myelogenous leukemia or myelodysplastic syndrome treated with busulfan and etoposide followed by autologous bone marrow transplantation and filgrastim G-CSF
Assess the toxicities of this regimen in this patient population
Assess the hematologic effects and toxicities of G-CSF given in this setting to these patients
Determine whether G-CSF stimulates leukemic relapse in these patients
Determine whether G-CSF has an affect on platelet recovery in this setting in these patients
OUTLINE Patients are stratified according to first second or third remission Patients undergo bone marrow collection
Patients receive oral busulfan every 6 hours for 16 doses on days -5 -4 -3 and -2 Patients receive etoposide IV over 4 hours on days -4 -3 and -2 Bone marrow is reinfused 36-48 hours after the last dose of etoposide Patients receive filgrastim G-CSF IV daily beginning 2-4 hours after bone marrow reinfusion until hematopoietic recovery
Patients are followed monthly for 1 year every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 2 years
Determine the overall survival and disease free survival of patients with acute myelogenous leukemia or myelodysplastic syndrome treated with busulfan and etoposide followed by autologous bone marrow transplantation and filgrastim G-CSF
Assess the toxicities of this regimen in this patient population
Assess the hematologic effects and toxicities of G-CSF given in this setting to these patients
Determine whether G-CSF stimulates leukemic relapse in these patients
Determine whether G-CSF has an affect on platelet recovery in this setting in these patients
OUTLINE Patients are stratified according to first second or third remission Patients undergo bone marrow collection
Patients receive oral busulfan every 6 hours for 16 doses on days -5 -4 -3 and -2 Patients receive etoposide IV over 4 hours on days -4 -3 and -2 Bone marrow is reinfused 36-48 hours after the last dose of etoposide Patients receive filgrastim G-CSF IV daily beginning 2-4 hours after bone marrow reinfusion until hematopoietic recovery
Patients are followed monthly for 1 year every 3 months for 1 year and then every 6 months thereafter
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 2 years
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-G00-1688 | None | None | None |
| NU-91H1T | None | None | None |