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ALFA-0701 was the trial that rescued the first ADC: giving gemtuzumab in three small doses with chemotherapy improved event-free survival without the toxicity that got it withdrawn.
Gemtuzumab 3 mg/m² on days 1, 4, 7. Median EFS 17.3 vs 9.5 months (HR 0.56, 95% CI 0.42-0.76); relapse-free survival improved; OS not significantly different in the final analysis (27.5 vs 21.8 months). Lancet 2012; basis of the 2017 US re-approval. Meta-analysis of five trials confirmed OS benefit in favourable- and intermediate-risk cytogenetics.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
280 enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survival (median)primary | GO + 7+3 | 135 | 17.3 months | 0.56 (0.42 to 0.76) | - | link |
| 7+3 | 136 | 9.5 months | ||||
| Overall survival (median) | GO + 7+3 | - | 27.5 months | - | - | link |
| 7+3 | - | 21.8 months |
The full inclusion and exclusion criteria are on the registry record. Read 2026-10-07. Recruiting overall does not mean a particular site is open; ask the study team.
ClinicalTrials.gov data courtesy of the US National Library of Medicine.
Shares COG AAML0531, Gemtuzumab ozogamicin.
Shares CD33, Gemtuzumab ozogamicin, Acute myeloid leukaemia.
Shares CD33, Acute myeloid leukaemia, Antibody-drug conjugate (ADC).
Shares CD33, Acute myeloid leukaemia.
Shares Gemtuzumab ozogamicin, Antibody-drug conjugate (ADC).
Shares Gemtuzumab ozogamicin, Antibody-drug conjugate (ADC).
Shares Cytarabine + anthracycline ('7+3'), Acute myeloid leukaemia.
Shares Gemtuzumab ozogamicin, Antibody-drug conjugate (ADC).
Every source this page cites, grouped by who published it. Grouping is read from the web address, not assigned by hand.
A source that has moved or gone is reported by the weekly link check. /audit/