A Phase 2 interventional study of filgrastim and sargramostim in Leukemia, sponsored by SWOG Cancer Research Network. Completed at 98 sites in United States. Open to participants aged 56 Years and older. Per ClinicalTrials.gov, last updated 2015-03-06.
Sponsored by SWOG Cancer Research Network · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combining cytarabine and daunorubicin in treating older patients who have acute myeloid leukemia that has not been previously treated.
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive induction chemotherapy comprising daunorubicin IV continuously over days 1-3 and cytarabine IV continuously over days 1-7. Patients may be treated with a second course of induction chemotherapy beginning on day 19 if remission is not achieved at that time. Patients also receive filgrastim (G-CSF) or sargramostim (GM-CSF) IV or subcutaneously daily beginning on day 15 and continuing until blood counts recover.
Patients who achieve remission after the first or second course of induction chemotherapy receive consolidation chemotherapy comprising daunorubicin IV continuously over days 1 and 2 and cytarabine IV continuously over days 1-5. Beginning no earlier than day 19, patients receive a second course of consolidation chemotherapy.
Patients are followed every 3 months for 1 year, every 6 months for 1 year, and then annually for 3 years.
PROJECTED ACCRUAL: Approximately 30-55 patients will be accrued for this study within 8-9 months.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 71 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed acute myeloid leukemia (AML)
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
induction: 5 mcg/kg/d IV or SC starting apx day 15
induction: 250 mcg/m2/d IV or SC starting apx day 1
ind: 200 mg/m2/d continuous IV days 1-7 consol: 200 mg/m2/d continuous IV days 1-5
ind and consol: 45 mg/m2/d continuous IV days 1-3
CR
Time frame: After induction therapy is completed
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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