NCT Number: NCT00274807
Combination Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
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.
Looking for future studies?
Notify MeKey information
Conditions
Age range
16 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Cytarabine
Drugetoposide
Drugmitoxantrone hydrochloride
DrugSponsors and collaborators
Lead sponsor
The Cleveland Clinic
Other
Collaborators
- National Cancer Institute (NCI)
Registry information
Official study title
Intensive Induction for Newly Diagnosed Acute Myelogenous Leukemia
Important dates
- Study start
- 2001
- Primary completion
- 2007
- Study completion
- 2008
- First posted
- Jan 11, 2006
- Registry last updated
- Feb 11, 2011
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Busulfan, Etoposide, and Total-Body Irradiation in Treating Patients Undergoing Donor Stem Cell or Bone Marrow Transplant for Advanced Hematologic Cancer
NCT00534430
Anemia, Anemia, Refractory
View Trial DetailsAuto BMT for Non-M3 AML in 1st Remission in Pts </=60y of Age Using Busulfan/FTBI & VP16 as a Prep R
NCT00534469
Bone Marrow Diseases, Congenital Abnormalities
View Trial DetailsAlloHCT From Matched Unrelated Donors in Pts w/ Advanced Hematologic Malignancies & Disorders
NCT00547196
Blast Crisis, Bone Marrow Diseases
Phoenix, Arizona, United States
View Trial DetailsEmpirical Versus Preemptive Antifungal Therapy
NCT01288378
Bacterial Infections and Mycoses, Bone Marrow Diseases
Bruges, Belgium
View Trial Details