Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia

Tracking Information
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.
Detailed Description	OBJECTIVES: 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.
Study Type ICMJE	Interventional
Study Phase	Phase 2
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Leukemia
Intervention ICMJE	Biological: filgrastim; Drug: cytarabine; Drug: etoposide; Drug: mitoxantrone hydrochloride
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.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: February 9, 2011)	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: Diagnosis of acute myeloid leukemia Previously untreated disease Previous hydroxyurea and/or corticosteroids are acceptable; No preexisting history of a hematologic disorder Myelodysplastic features allowed; No acute leukemia secondary to previous therapy; No leukemic meningitis PATIENT CHARACTERISTICS: Bilirubin < 2.0 mg/dL (unless felt to be increased because of hepatic infiltration with leukemia); Creatinine < 2.0 mg/dL; Pregnant or lactating patients are ineligible; Fertile patients must use effective contraception; No history of or active congestive heart failure PRIOR CONCURRENT THERAPY: See Disease Characteristics
Sex/Gender	Sexes Eligible for Study: All
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
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	Study Chair: Matt E. Kalaycio, MD The Cleveland Clinic
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