Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00053131
Status:
COMPLETED
Last Update Posted:
2011-03-08
First Post:
2003-01-27
Brief Title:
Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
High Dose Cytarabine And Mitoxantrone Therapy For Relapsed And Refractory Acute Myeloid And Lymphocytic Leukemia Effects Of GM-CSF Versus G-CSF On Dendritic Cells And Leukemia Associated Antigen-Specific T-Lymphocytes
Status:
COMPLETED
Status Verified Date:
2011-03
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 or die Colony-stimulating factors such as filgrastim and sargramostim 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 It is not yet known whether combination chemotherapy is more effective followed by filgrastim or sargramostim in treating leukemia
PURPOSE Randomized phase II trial to compare the effectiveness of combination chemotherapy followed by filgrastim with that of combination chemotherapy followed by sargramostim in treating patients who have relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia
PURPOSE Randomized phase II trial to compare the effectiveness of combination chemotherapy followed by filgrastim with that of combination chemotherapy followed by sargramostim in treating patients who have relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia
Detailed Description:
OBJECTIVES
Compare amounts of dendritic cells and leukemia-associated antigen-specific T lymphocytes in patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with filgrastim G-CSF vs sargramostim GM-CSF after high-dose cytarabine and mitoxantrone
OUTLINE This is a randomized study
All patients receive high-dose cytarabine IV over 1 hour twice daily on days 1-6 and mitoxantrone IV over 30 minutes on days 2-4 On day 6 patients are randomized to 1 of 2 treatment arms
Arm I Patients receive filgrastim G-CSF subcutaneously SC daily until blood counts recover in the absence of unacceptable toxicity
Arm II Patients receive sargramostim GM-CSF SC daily as in arm I
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 6 years
Compare amounts of dendritic cells and leukemia-associated antigen-specific T lymphocytes in patients with relapsed or refractory acute myeloid leukemia or acute lymphoblastic leukemia treated with filgrastim G-CSF vs sargramostim GM-CSF after high-dose cytarabine and mitoxantrone
OUTLINE This is a randomized study
All patients receive high-dose cytarabine IV over 1 hour twice daily on days 1-6 and mitoxantrone IV over 30 minutes on days 2-4 On day 6 patients are randomized to 1 of 2 treatment arms
Arm I Patients receive filgrastim G-CSF subcutaneously SC daily until blood counts recover in the absence of unacceptable toxicity
Arm II Patients receive sargramostim GM-CSF SC daily as in arm I
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study within 6 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 |
|---|---|---|---|
| RPCI-RPC-9902 | None | None | None |