Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse (three open-label phase 2 trials)
Phase 2N = 142
- Population
- Patients with CD33-positive AML in untreated first relapse and no antecedent hematologic disorder; median age 61 years.
- Design
- Three open-label, multicentre trials of single-agent gemtuzumab ozogamicin (Mylotarg) 9 mg/m2 at 2-week intervals for two doses; the basis of the US accelerated approval of 2000.
- Arms
- Gemtuzumab ozogamicin (experimental, n = 142): Gemtuzumab ozogamicin 9 mg/m2 at 2-week intervals for two doses (single agent)
- People
- Sievers EL, Mylotarg Study Group
Show the numbers
| Endpoint | Analysis | Gemtuzumab ozogamicin | Control | Effect |
|---|---|---|---|---|
| Overall remission rateAll 142 patients in the three trials | primaryBross 2001 | 30% | — | Overall response rate in the phase 2 studies including complete remission with incomplete platelet recovery (CRp), as summarised by the FDA approval summary. The Sievers 2001 report of the same trials states that thirty percent of patients obtained remission (5% or fewer marrow blasts, neutrophil recovery to at least 1,500/microL, and RBC and platelet transfusion independence). |
| Complete remission ratePatients in the three phase 2 trials (142 patients) | primaryBross 2001 | 16% | — | Complete response with full recovery of hematopoiesis, as summarised in the FDA approval summary; the abstract does not give a confidence interval. |
| Endpoint | Analysis | Gemtuzumab ozogamicin | Control | Effect |
|---|---|---|---|---|
| Overall remission rateAll 142 patients in the three trials | primaryBross 2001 | 30% | — | Overall response rate in the phase 2 studies including complete remission with incomplete platelet recovery (CRp), as summarised by the FDA approval summary. The Sievers 2001 report of the same trials states that thirty percent of patients obtained remission (5% or fewer marrow blasts, neutrophil recovery to at least 1,500/microL, and RBC and platelet transfusion independence). |
| Complete remission ratePatients in the three phase 2 trials (142 patients) | primaryBross 2001 | 16% | — | Complete response with full recovery of hematopoiesis, as summarised in the FDA approval summary; the abstract does not give a confidence interval. |
Appears in
Sources
Sievers EL, Larson RA, Stadtmauer EA, Estey E, Löwenberg B, Dombret H, et al. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J Clin Oncol. 2001;19(13):3244-54.
Bross PF, Beitz J, Chen G, Chen XH, Duffy E, Kieffer L, et al. Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia. Clin Cancer Res. 2001;7(6):1490-6.