S0106
A phase 3 study of gemtuzumab ozogamicin during induction and postconsolidation therapy in younger patients with acute myeloid leukemia
Phase 3N = 637NCT00085709
- Population
- Younger patients (ClinicalTrials.gov: under age 61) with previously untreated de novo AML (637 registered for induction; 174 randomised after consolidation).
- Design
- Randomised phase 3. Induction: daunorubicin 45 mg/m2 on days 1 to 3 with cytarabine 100 mg/m2 per day by continuous infusion on days 1 to 7 plus gemtuzumab ozogamicin (GO) 6 mg/m2 on day 4 (DA+GO), versus daunorubicin 60 mg/m2 on days 1 to 3 with cytarabine alone (DA). Patients in complete remission received 3 courses of high-dose cytarabine; those still in remission were randomised to no additional therapy or 3 doses of GO 5 mg/m2 every 28 days. Registered August 2004 to August 2009.
- Arms
- Daunorubicin plus cytarabine (DA) (control): Daunorubicin 60 mg/m2 on days 1 to 3 plus cytarabine 100 mg/m2 per day by continuous infusion for 7 days
- DA plus gemtuzumab ozogamicin (experimental): Daunorubicin 45 mg/m2 on days 1 to 3 plus cytarabine 100 mg/m2 per day for 7 days plus gemtuzumab ozogamicin 6 mg/m2 on day 4
- People
- Petersdorf SH, SWOG
Δ Complete remission rate−1 pointsΔ 60-month RFS+1 pointsΔ 60-month OS−4 pointsDFSHR 1.48
Show the numbers
| Endpoint | Analysis | DA plus gemtuzumab ozogamicin | Daunorubicin plus cytarabine (DA) | Effect |
|---|---|---|---|---|
| Complete remission ratePatients randomised at induction (637 registered) | primaryPetersdorf 2013 | 69% | 70% | P=.59 |
| RFSPatients who achieved complete remission | primaryPetersdorf 2013 | 43% at 5 y | 42% at 5 y | P=.40 |
| OSPatients randomised at induction (637 registered) | primaryPetersdorf 2013 | 46% at 5 y | 50% at 5 y | P=.85The abstract states the 5-year rates; it does not name the primary endpoint or give confidence intervals. |
| DFSPatients in remission after consolidation who were randomised to postconsolidation GO or no further therapy (174 patients) | primaryPetersdorf 2013 | — | — | HR 1.48P=.97Hazard ratio and P value exactly as printed in the abstract; the abstract does not give a confidence interval, the direction of the comparison or the test sidedness. |
| Endpoint | Analysis | DA plus gemtuzumab ozogamicin | Daunorubicin plus cytarabine (DA) | Effect |
|---|---|---|---|---|
| Complete remission ratePatients randomised at induction (637 registered) | primaryPetersdorf 2013 | 69% | 70% | P=.59 |
| RFSPatients who achieved complete remission | primaryPetersdorf 2013 | 43% at 5 y | 42% at 5 y | P=.40 |
| OSPatients randomised at induction (637 registered) | primaryPetersdorf 2013 | 46% at 5 y | 50% at 5 y | P=.85The abstract states the 5-year rates; it does not name the primary endpoint or give confidence intervals. |
| DFSPatients in remission after consolidation who were randomised to postconsolidation GO or no further therapy (174 patients) | primaryPetersdorf 2013 | — | — | HR 1.48P=.97Hazard ratio and P value exactly as printed in the abstract; the abstract does not give a confidence interval, the direction of the comparison or the test sidedness. |