Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00398047
Status:
TERMINATED
Last Update Posted:
2018-09-06
First Post:
2006-11-09
Brief Title:
Azacitidine Darbepoetin Alfa and Erythropoietin and Filgastrim G-CSF in Treating Patients With Myelodysplastic Syndromes
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Combination of Azacitadine and Hematopoietic Growth Factors for Myelodysplastic Syndrome
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow accrual
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 such as azacitidine work in different ways to stop the growth of abnormal cells either by killing the cells or by stopping them from dividing Colony-stimulating factors such as darbepoetin alfa and G-CSF may increase the number of red blood cells and white blood cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy Giving azacitidine together with darbepoetin alfa and G-CSF may be an effective treatment for myelodysplastic syndromes
PURPOSE This clinical trial is studying how well giving azacitidine together with darbepoetin alfa and G-CSF works in treating patients with myelodysplastic syndromes
PURPOSE This clinical trial is studying how well giving azacitidine together with darbepoetin alfa and G-CSF works in treating patients with myelodysplastic syndromes
Detailed Description:
OBJECTIVES
Primary
Determine the hematological response rate in patients with myelodysplastic syndromes treated with azacitidine darbepoetin alfa and filgrastim G-CSF
Secondary
Determine the time to leukemia progression survival and changes in apoptotic index of bone marrow in patients treated with this regimen
OUTLINE This is an open-label nonrandomized study
Initial therapy courses 1 and 2 Patients receive azacitidine subcutaneously SC or intra-venous IV on days 1-5 week 1 and darbepoetin alfa SC on day 8 week 2 Treatment repeats every 28 days for 2 courses
Patients undergo bone marrow aspirate and biopsy to assess response Patients with a major hematological improvement OR with grade 3-4 hematological toxicities during the first 2 courses of therapy ANDOR 50 reduction in bone marrow cellularity compared to baseline proceed to optimization therapy A Patients not meeting any of the above criteria proceed to optimization therapy B Patients with disease progression are removed from study
Optimization therapy A courses 3-8 Patients receive azacitidine SC or IV on days 1-5 week 1 darbepoetin alfa SC on day 8 week 2 and filgrastim G-CSF SC 3 times weekly in weeks 2-4
Optimization therapy B courses 3-8 Patients receive a higher dose of azacitidine on days 1-5 week 1 darbepoetin alfa SC on day 8 week 2 and G-CSF 3 times weekly in weeks 2-4
In both optimization therapy A and B treatment repeats every 28 days for 6 courses Patients with any degree of hematological improvement after initial therapy and optimization therapy proceed to maintenance therapy
Maintenance therapy course 9 and all subsequent courses Patients receive azacitidine on days 1-5 week 1 Only patients with anemia hemoglobin 12 gdL andor neutropenia absolute neutrophil count 1500mm ³ at the start of any given course during maintenance therapy receive darbepoetin alfa SC beginning on day 8 week 2 and continuing once every 21 days and G-CSF SC 3 times weekly beginning in week 2
Courses repeat every 28-56 days determined by the treating physician in the absence of disease progression or unacceptable toxicity
Bone marrow samples are obtained at baseline and after the completion of course 2 of study treatment for apoptosis analysis flow cytometry and gene expression profiles of p53 and p21 by immunohistochemistry Peripheral blood samples are obtained periodically and analyzed for hemoglobin F quantitation
NOTE Administered only if the patient is anemic hemoglobin 12 gdL
NOTE Darbepoetin alfa is held if hemoglobin 12 gdL on day 1 of a given cycle
Primary
Determine the hematological response rate in patients with myelodysplastic syndromes treated with azacitidine darbepoetin alfa and filgrastim G-CSF
Secondary
Determine the time to leukemia progression survival and changes in apoptotic index of bone marrow in patients treated with this regimen
OUTLINE This is an open-label nonrandomized study
Initial therapy courses 1 and 2 Patients receive azacitidine subcutaneously SC or intra-venous IV on days 1-5 week 1 and darbepoetin alfa SC on day 8 week 2 Treatment repeats every 28 days for 2 courses
Patients undergo bone marrow aspirate and biopsy to assess response Patients with a major hematological improvement OR with grade 3-4 hematological toxicities during the first 2 courses of therapy ANDOR 50 reduction in bone marrow cellularity compared to baseline proceed to optimization therapy A Patients not meeting any of the above criteria proceed to optimization therapy B Patients with disease progression are removed from study
Optimization therapy A courses 3-8 Patients receive azacitidine SC or IV on days 1-5 week 1 darbepoetin alfa SC on day 8 week 2 and filgrastim G-CSF SC 3 times weekly in weeks 2-4
Optimization therapy B courses 3-8 Patients receive a higher dose of azacitidine on days 1-5 week 1 darbepoetin alfa SC on day 8 week 2 and G-CSF 3 times weekly in weeks 2-4
In both optimization therapy A and B treatment repeats every 28 days for 6 courses Patients with any degree of hematological improvement after initial therapy and optimization therapy proceed to maintenance therapy
Maintenance therapy course 9 and all subsequent courses Patients receive azacitidine on days 1-5 week 1 Only patients with anemia hemoglobin 12 gdL andor neutropenia absolute neutrophil count 1500mm ³ at the start of any given course during maintenance therapy receive darbepoetin alfa SC beginning on day 8 week 2 and continuing once every 21 days and G-CSF SC 3 times weekly beginning in week 2
Courses repeat every 28-56 days determined by the treating physician in the absence of disease progression or unacceptable toxicity
Bone marrow samples are obtained at baseline and after the completion of course 2 of study treatment for apoptosis analysis flow cytometry and gene expression profiles of p53 and p21 by immunohistochemistry Peripheral blood samples are obtained periodically and analyzed for hemoglobin F quantitation
NOTE Administered only if the patient is anemic hemoglobin 12 gdL
NOTE Darbepoetin alfa is held if hemoglobin 12 gdL on day 1 of a given cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| P30CA012197 | NIH | None | None |
| CCCWFU-29106 | OTHER | Comprehensive Cancer Center of WFUHS | httpsreporternihgovquickSearchP30CA012197 |