Immunotherapeutic approaches (gemtuzumab ozogamicin)

In the SJCRH AML02 (NCT00136084) trial, gemtuzumab ozogamicin was given alone (n = 17), typically where MRD was low but still detectable (0.1%–5.6%), or in combination with chemotherapy (n = 29) to patients with high MRD (1%–97%) after the first induction cycle.[55]

In the SJCRH AML02 (NCT00136084) trial, gemtuzumab ozogamicin was given alone (n = 17), typically where MRD was low but still detectable (0.1%–5.6%), or in combination with chemotherapy (n = 29) to patients with high MRD (1%–97%) after the first induction cycle.[55]

When given alone, 13 of 17 patients became MRD negative.

In the SJCRH AML02 (NCT00136084) trial, gemtuzumab ozogamicin was given alone (n = 17), typically where MRD was low but still detectable (0.1%–5.6%), or in combination with chemotherapy (n = 29) to patients with high MRD (1%–97%) after the first induction cycle.[55]

When given in combination with chemotherapy, 13 of 29 patients became MRD negative and 28 of 29 patients had reductions in MRD.

In the SJCRH AML02 (NCT00136084) trial, gemtuzumab ozogamicin was given alone (n = 17), typically where MRD was low but still detectable (0.1%–5.6%), or in combination with chemotherapy (n = 29) to patients with high MRD (1%–97%) after the first induction cycle.[55]

Compared with a nonrandomized cohort of patients with 1% to 25% MRD after induction 1, addition of gemtuzumab ozogamicin to chemotherapy versus chemotherapy alone resulted in significant differences in MRD (P = .03); MRD was eliminated or reduced in all patients who received gemtuzumab ozogamicin versus in only 82% of patients who did not receive gemtuzumab ozogamicin. This result was seen despite higher postinduction 1 MRD levels in the cohort of patients who received gemtuzumab ozogamicin (median, 9.5% vs. 2.9% in the no gemtuzumab ozogamicin group; P < .01). There was a nonstatistically significant improvement in 5-year OS rates (55% ± 13.9% vs. 36.4% ± 9.7%; P = .28) and EFS rates (50% ± 9.3% vs. 31.8% ± 13.4%; P = .28).

In the SJCRH AML02 (NCT00136084) trial, gemtuzumab ozogamicin was given alone (n = 17), typically where MRD was low but still detectable (0.1%–5.6%), or in combination with chemotherapy (n = 29) to patients with high MRD (1%–97%) after the first induction cycle.[55]

No impact on HSCT treatment-related mortality was seen.

A phase II trial of gemtuzumab ozogamicin alone for children with relapsed/refractory AML that did not respond to previous reinduction attempts demonstrated the following results:[25]

A phase II trial of gemtuzumab ozogamicin alone for children with relapsed/refractory AML that did not respond to previous reinduction attempts demonstrated the following results:[25]

Of 30 patients, 11 achieved a CR or partial CR. The 3-year OS rate was 27% for responders versus 0% for nonresponders (P = .001).