Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
NCT ID: NCT00274807
Last Updated: 2011-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2001-06-30
2008-05-31
Brief Summary
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PURPOSE: This phase II trial is studying how well combination chemotherapy works in treating patients with newly diagnosed acute myeloid leukemia.
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Detailed Description
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* Determine the complete remission rate in patients with acute myelogenous leukemia treated with induction chemotherapy comprising mitoxantrone hydrochloride, cytarabine, and etoposide.
* Determine the feasibility and toxicity of this regimen when given to patients with newly diagnosed acute myelogenous leukemia.
OUTLINE: Patients receive induction chemotherapy comprising mitoxantrone hydrochloride IV on days 1-3, cytarabine IV continuously over 72 hours on days 1-3 and 8-10, and etoposide IV continuously over 72 hours on days 8-10. Patients also receive filgrastim (G-CSF) subcutaneously once daily beginning on day 4 and continuing until blood counts recover.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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filgrastim
cytarabine
etoposide
mitoxantrone hydrochloride
Eligibility Criteria
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Inclusion Criteria
* No history of or active congestive heart failure
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
16 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
The Cleveland Clinic
OTHER
Responsible Party
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Cleveland Clinic Foundation
Principal Investigators
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Matt E. Kalaycio, MD
Role: STUDY_CHAIR
The Cleveland Clinic
Other Identifiers
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CASE-CCF-4409
Identifier Type: -
Identifier Source: secondary_id
CASE-CCF-0645
Identifier Type: -
Identifier Source: secondary_id
CASE-CCF-4409
Identifier Type: -
Identifier Source: org_study_id
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