Inotuzumab ozogamicin followed by allogeneic BMT

A randomized phase III study compared inotuzumab ozogamicin with one of three standard reinduction regimens. The trial enrolled 218 patients, aged 18 years or older, who had relapsed or refractory disease and were to receive their first or second salvage regimen.[10] The three standard regimens consisted of fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG), cytarabine and mitoxantrone, or high-dose cytarabine.

A randomized phase III study compared inotuzumab ozogamicin with one of three standard reinduction regimens. The trial enrolled 218 patients, aged 18 years or older, who had relapsed or refractory disease and were to receive their first or second salvage regimen.[10] The three standard regimens consisted of fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG), cytarabine and mitoxantrone, or high-dose cytarabine.

Complete remission or complete remission with incomplete count recovery rates were 80.7% (95% CI, 72.1%–87.7%) in the inotuzumab group versus 29.4% (95% CI, 21.0%–38.8%) in the standard-treatment group (P < .001).

A randomized phase III study compared inotuzumab ozogamicin with one of three standard reinduction regimens. The trial enrolled 218 patients, aged 18 years or older, who had relapsed or refractory disease and were to receive their first or second salvage regimen.[10] The three standard regimens consisted of fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG), cytarabine and mitoxantrone, or high-dose cytarabine.

Progression-free survival was superior in the inotuzumab-treated group (5.0 months vs. 1.8 months in the standard-treatment group) with an HR of 0.45 (97.5 CI, 0.34–0.61; P < .001).

A randomized phase III study compared inotuzumab ozogamicin with one of three standard reinduction regimens. The trial enrolled 218 patients, aged 18 years or older, who had relapsed or refractory disease and were to receive their first or second salvage regimen.[10] The three standard regimens consisted of fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG), cytarabine and mitoxantrone, or high-dose cytarabine.

Duration of remission was short in both groups; duration in the inotuzumab group was 4.6 months (95% CI, 3.9–5.4) and duration in the standard chemotherapy group was 3.1 months (95% CI, 1.4–4.9).

A randomized phase III study compared inotuzumab ozogamicin with one of three standard reinduction regimens. The trial enrolled 218 patients, aged 18 years or older, who had relapsed or refractory disease and were to receive their first or second salvage regimen.[10] The three standard regimens consisted of fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG), cytarabine and mitoxantrone, or high-dose cytarabine.

Of the 48 patients in the inotuzumab arm who proceeded to transplant after therapy, 10 developed veno-occlusive disease. Of the 20 patients who proceeded to transplant after remission on the standard chemotherapy arm, 1 developed veno-occlusive disease.

A randomized phase III study compared inotuzumab ozogamicin with one of three standard reinduction regimens. The trial enrolled 218 patients, aged 18 years or older, who had relapsed or refractory disease and were to receive their first or second salvage regimen.[10] The three standard regimens consisted of fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG), cytarabine and mitoxantrone, or high-dose cytarabine.

OS was not statistically prolonged in the inotuzumab group (7.7 months in the inotuzumab group vs. 6.7 months in the standard-treatment group) (HR, 0.77; 97.5% CI, 0.58–1.03; P = .04) because of a failure to meet a study-prespecified boundary of P = .0208.

A randomized phase III study compared inotuzumab ozogamicin with one of three standard reinduction regimens. The trial enrolled 218 patients, aged 18 years or older, who had relapsed or refractory disease and were to receive their first or second salvage regimen.[10] The three standard regimens consisted of fludarabine, cytarabine, and granulocyte colony-stimulating factor (FLAG), cytarabine and mitoxantrone, or high-dose cytarabine.

Grade 3 or higher adverse events were more common in the inotuzumab group. Veno-occlusive disease of the liver occurred in 11% of patients in the inotuzumab group and 1% of patients in the standard-treatment group.