Risk Adapted Treatment for Primary Acute Myeloid Leukemia (AML)
Summary
The AML-03 regimen investigates the addition of G-CSF priming to both induction and consolidation chemotherapies administrated in the previous AML-99 trial (NCT01716793) refines risk-stratification based on biological characterization also the AML-03 trial incorporates novel approaches for hematopoietic stem cell transplantation: such as Mylotarg™ "in vivo purging" in autografts, extends unrelated volunteers donors for allotransplants in high-risk patients, and introduces reduced intensity conditioning in patients with elder age (more than 50 years old). The aims of these modifications are to analyse eficacy and toxicity of this induction and consolidation therapy and to analyse the disease free survival in patients who achieved complete response following a risk adjusted therapy.
Timeline
- Start
- 2003-10
- Primary completion
- 2012-03
- Completion
- 2012-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cytarabine | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 3000 mg/m2 | Intravenous |
| Background | G-CSF | Unknown | — | Subcutaneous |