Selected clinical trials in acute myeloid leukemia (AML).
| Abbreviations: APL, acute promyelocytic leukemia; ATRA, all-trans retinoic acid; ara-C, cytosine arabinoside; 6MP, 6-mercaptopurine; AML, acute myeloid leukemia; PBSCT, peripheral blood stem cell transplantation; IL, interleukin; MDR, multidrug resistance; BMT, bone marrow transplantation; G-CSF, granulocyte colony-stimulating factor | |
| US Intergroup | APL: ATRA/daunorubicin/ara-C induction, followed by As203 + daunorubicin/ATRA × 2 vs daunorubicin/ ATRA × 2 consolidation, followed by ATRA/6MP/methotrexate vs ATRA × 1 yr for maintenance. |
| AML (age > 70 years and not a candidate for chemotherapy): Oral tipifarnib (R115777) at 2 doses and 2 schedules | |
| CALGB | AML (age > 60): dauno/ara-C vs dauno/ara-C/oblimersen AML (age < 60): dauno/ara-C/etoposide, followed by post-chemotherapy/PBSCT, followed by IL-2 vs observation |
| ECOG | AML (age > 60): dauno/ara-C ± MDR modulator (LY335979) |
| AML (age < 60): daunorubicin (45 mg/m2 × 3 d)/ara-C vs daunorubicin (90 mg/m2 × 3 d)/ara-C, followed by ± gemtuzumab ozogamicin (GO) prior to autoPBSCT (if no sib donor) | |
| SWOG | AML (age > 55): continuous infusion daunorubicin/ara-C ± cyclosporine A followed by assignment to mini-allo BMT (if HLA-matched sibling donor) |
| AML (age ≤ 55): daunorubicin/ara-C vs daunorubicin/ara-C + GO | |
| EORTC | AML (age > 60): ida/ara-C vs ida/ara-C/GO |
| AML (age < 60): ida/ara-C vs ida/high dose ara-C, followed by intensive consolidation/allogeneic BMT, followed by IL-2 | |
| HOVON | AML (age > 60): dauno (45 mg/m2)/ara-C vs dauno (90 mg/m2)/ara-C f/b intermediate dose ara-C, followed by GO × 4 vs observation |
| AML (age < 60): ida/ara-C ± G-CSF vs ida/high-dose ara-C ± G-CSF, followed by mitoxantrone/etoposide (good risk) or Mito/etop vs autoBMT or alloBMT (if sibling donor) | |
| MRC | APL: ATRA/dauno/high-dose ara-C/6-thioguanine (MRC) vs ATRA/ida (Spanish), followed by MRC or Spanish chemo ± GO |
| AML (age > 60): intensive chemo (dauno/ara-c at various doses) vs non-intensive chemo (hydroxyurea/low dose ara-C ± ATRA) | |
| AML (age < 60): dauno/high dose ara-C/6-thioguanine vs fludarabine/ara-C/G-CSF/ida +/- GO, followed by allo BMT (if sibling; and will be nonmyeloablative if > 50, ‘full’ if under 35 years old) | |
| Abbreviations: APL, acute promyelocytic leukemia; ATRA, all-trans retinoic acid; ara-C, cytosine arabinoside; 6MP, 6-mercaptopurine; AML, acute myeloid leukemia; PBSCT, peripheral blood stem cell transplantation; IL, interleukin; MDR, multidrug resistance; BMT, bone marrow transplantation; G-CSF, granulocyte colony-stimulating factor | |
| US Intergroup | APL: ATRA/daunorubicin/ara-C induction, followed by As203 + daunorubicin/ATRA × 2 vs daunorubicin/ ATRA × 2 consolidation, followed by ATRA/6MP/methotrexate vs ATRA × 1 yr for maintenance. |
| AML (age > 70 years and not a candidate for chemotherapy): Oral tipifarnib (R115777) at 2 doses and 2 schedules | |
| CALGB | AML (age > 60): dauno/ara-C vs dauno/ara-C/oblimersen AML (age < 60): dauno/ara-C/etoposide, followed by post-chemotherapy/PBSCT, followed by IL-2 vs observation |
| ECOG | AML (age > 60): dauno/ara-C ± MDR modulator (LY335979) |
| AML (age < 60): daunorubicin (45 mg/m2 × 3 d)/ara-C vs daunorubicin (90 mg/m2 × 3 d)/ara-C, followed by ± gemtuzumab ozogamicin (GO) prior to autoPBSCT (if no sib donor) | |
| SWOG | AML (age > 55): continuous infusion daunorubicin/ara-C ± cyclosporine A followed by assignment to mini-allo BMT (if HLA-matched sibling donor) |
| AML (age ≤ 55): daunorubicin/ara-C vs daunorubicin/ara-C + GO | |
| EORTC | AML (age > 60): ida/ara-C vs ida/ara-C/GO |
| AML (age < 60): ida/ara-C vs ida/high dose ara-C, followed by intensive consolidation/allogeneic BMT, followed by IL-2 | |
| HOVON | AML (age > 60): dauno (45 mg/m2)/ara-C vs dauno (90 mg/m2)/ara-C f/b intermediate dose ara-C, followed by GO × 4 vs observation |
| AML (age < 60): ida/ara-C ± G-CSF vs ida/high-dose ara-C ± G-CSF, followed by mitoxantrone/etoposide (good risk) or Mito/etop vs autoBMT or alloBMT (if sibling donor) | |
| MRC | APL: ATRA/dauno/high-dose ara-C/6-thioguanine (MRC) vs ATRA/ida (Spanish), followed by MRC or Spanish chemo ± GO |
| AML (age > 60): intensive chemo (dauno/ara-c at various doses) vs non-intensive chemo (hydroxyurea/low dose ara-C ± ATRA) | |
| AML (age < 60): dauno/high dose ara-C/6-thioguanine vs fludarabine/ara-C/G-CSF/ida +/- GO, followed by allo BMT (if sibling; and will be nonmyeloablative if > 50, ‘full’ if under 35 years old) | |