Status:
COMPLETED
Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia, Myelocytic, Acute
Eligibility:
All Genders
Up to 21 years
Phase:
PHASE3
Brief 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.
Detailed Description
The study compares the effectiveness of two doses of cytarabine combined with set doses of daunomycin and etoposide as an initial course of chemotherapy to eliminate minimal residual disease. Subseque...
Eligibility Criteria
Inclusion
- 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
- Positive pregnancy test
- Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia (JMML)
Key Trial Info
Start Date :
August 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT00136084
Start Date
August 1 2002
End Date
June 1 2012
Last Update
December 5 2012
Active Locations (8)
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1
Stanford University Medical Center
Palo Alto, California, United States, 94304
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
3
Children's Hospital of Michigan (Wayne State University)
Detroit, Michigan, United States, 48201
4
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105