Combination Chemotherapy Followed By Filgrastim or Sargramostim in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT00053131|
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : March 8, 2011
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 person's 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.
|Condition or disease||Intervention/treatment||Phase|
|Leukemia||Biological: filgrastim Biological: sargramostim Drug: cytarabine Drug: mitoxantrone hydrochloride||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|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|
|Study Start Date :||January 1999|
|Actual Primary Completion Date :||February 2004|
|Actual Study Completion Date :||February 2004|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00053131
|United States, New York|
|Roswell Park Cancer Institute|
|Buffalo, New York, United States, 14263-0001|
|Study Chair:||Maria R. Baer, MD||Roswell Park Cancer Institute|