Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia

Completed · Phase 3

Conditions studied: Leukemia, Myelocytic, Acute

In brief

The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy regimens using different dosages of cytarabine to eliminate all detectable leukemia.

Key facts

Study ID

NCT00136084

Run by

St. Jude Children's Research Hospital

People needed

238

Starts

2002-08-01

Expected to finish

2012-06-01

Last updated by the study team

2012-12-05

Who can join

Age: any, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of acute myeloid leukemia by immunophenotyping, morphology, and cytochemical staining; myelodysplasia; or biphenotypic leukemia.
• Age less than or equal to 21 years at time of study entry.
• No prior therapy for this malignancy (patients with secondary AML following treatment of primary malignancy are eligible) except for one dose of intrathecal therapy.
• Negative pregnancy test
• Patient does not have Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)

You may not qualify if…

• Positive pregnancy test
• Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)

Where it is running

• Stanford University Medical Center — Palo Alto, California, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States
• Children's Hospital of Michigan (Wayne State University) — Detroit, Michigan, United States
• St. Jude Children's Research Hospital — Memphis, Tennessee, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Texas Children's Cancer Center — Houston, Texas, United States
• Seattle Children's Hospital — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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