drugset / Trial / NCT00136084
Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
Phase 3
Completed
238 enrolled
St. Jude Children's Research Hospital
National Cancer Institute (NCI) · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2002-08
- Primary completion
- 2008-07
- Completion
- 2012-06
Publications
- Elsayed AH, Rafiee R, Cao X, Raimondi S, Downing JR, Ribeiro R, Fan Y, Gruber TA, Baker S, Klco J, Rubnitz JE, Pounds S, Lamba JK. A six-gene leukemic stem cell score identifies high risk pediatric acute myeloid leukemia. Leukemia. 2020 Mar;34(3):735-745. doi: 10.1038/s41375-019-0604-8. Epub 2019 Oct 23.
- Gamazon ER, Lamba JK, Pounds S, Stark AL, Wheeler HE, Cao X, Im HK, Mitra AK, Rubnitz JE, Ribeiro RC, Raimondi S, Campana D, Crews KR, Wong SS, Welsh M, Hulur I, Gorsic L, Hartford CM, Zhang W, Cox NJ, Dolan ME. Comprehensive genetic analysis of cytarabine sensitivity in a cell-based model identifies polymorphisms associated with outcome in AML patients. Blood. 2013 May 23;121(21):4366-76. doi: 10.1182/blood-2012-10-464149. Epub 2013 Mar 28.
- Rubnitz JE, Inaba H, Dahl G, Ribeiro RC, Bowman WP, Taub J, Pounds S, Razzouk BI, Lacayo NJ, Cao X, Meshinchi S, Degar B, Airewele G, Raimondi SC, Onciu M, Coustan-Smith E, Downing JR, Leung W, Pui CH, Campana D. Minimal residual disease-directed therapy for childhood acute myeloid leukaemia: results of the AML02 multicentre trial. Lancet Oncol. 2010 Jun;11(6):543-52. doi: 10.1016/S1470-2045(10)70090-5. Epub 2010 May 5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 1000 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 3000 mg/m2 | Intravenous |
| Subject | Gemtuzumab Ozogamicin | Monoclonal antibody | 3 mg/m2 | Intravenous |
| Subject | Gemtuzumab Ozogamicin | Monoclonal antibody | 6 mg/m2 | Intravenous |
| Background | Cladribine | Small molecule | 9 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Daunorubicin | Small molecule | 50 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | — | — |
| Background | Etoposide | Small molecule | 100 mg/m2 | Intravenous |
| Background | Etoposide | Small molecule | 125 mg/m2 | Intravenous |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | — |
| Background | Methotrexate | Small molecule | — | — |
| Background | Mitoxantrone | Small molecule | 10 mg/m2 | Intravenous |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Vincristine | Small molecule | — | — |
| Background | asparaginase | Protein / enzyme biologic | 6000 unknown | Intramuscular |