Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Jude Children's Research Hospital
• Collaborator: National Cancer Institute (NCI)
• Treatments: 6-Mercaptopurine; Asparaginase; Cladribine; Cyclophosphamide; Cytarabine; Daunorubicin; Dexamethasone; Etoposide; Gemtuzumab; Mercaptopurine; Methotrexate; Mitoxantrone; Prednisone; Vincristine

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Positive pregnancy test

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