Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
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ClinicalTrials.gov Identifier: NCT00274807 |
Recruitment Status
:
Completed
First Posted
: January 11, 2006
Last Update Posted
: February 11, 2011
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Tracking Information | ||||
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First Submitted Date ICMJE | January 10, 2006 | |||
First Posted Date ICMJE | January 11, 2006 | |||
Last Update Posted Date | February 11, 2011 | |||
Study Start Date ICMJE | June 2001 | |||
Actual Primary Completion Date | April 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE | Not Provided | |||
Original Primary Outcome Measures ICMJE | Not Provided | |||
Change History | Complete list of historical versions of study NCT00274807 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | |||
Official Title ICMJE | Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia | |||
Brief Summary | RATIONALE: Drugs used in chemotherapy, such as mitoxantrone, cytarabine, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. 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 | OBJECTIVES:
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. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Leukemia | |||
Intervention ICMJE |
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Study Arms | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
40 | |||
Original Enrollment ICMJE | Not Provided | |||
Actual Study Completion Date | May 2008 | |||
Actual Primary Completion Date | April 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Sex/Gender |
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Ages | 16 Years and older (Child, Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00274807 | |||
Other Study ID Numbers ICMJE | CASE-CCF-4409 P30CA043703 ( U.S. NIH Grant/Contract ) CASE-CCF-4409 CASE-CCF-0645 |
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Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Matt Kalaycio, Cleveland Clinic Foundation | |||
Study Sponsor ICMJE | The Cleveland Clinic | |||
Collaborators ICMJE | National Cancer Institute (NCI) | |||
Investigators ICMJE |
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PRS Account | The Cleveland Clinic | |||
Verification Date | February 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |