Overview

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)