Selected trials in ALL
| Trial . | clinicaltrials.gov identifier . | Disease . | InO schedule . | No. of patients . | CR, % . | VOD . | Notes . |
|---|---|---|---|---|---|---|---|
| Phase 1/230 | NCT01363297 | R/R B-ALL, Ph+ included | 1.2-1.8 mg/m2 per cycle given on days 1, 8, 15; 1.8 for phase 2 | 72 | 68 | 4 | |
| Phase 228,29 | NCT01134575 | R/R B-ALL, Ph+ included | 1.3-1.8 mg/m2 once per cycle (n = 49). 1.8 mg/m2 per cycle given on days 1, 8, 15 (n = 41) | 90 | 58 (CR + CRp + CRi) | 6/90, 6/36 transplant patients | Noted reduced adverse events with weekly dosing |
| Phase 2 combing InO with chemotherapy41 | NCT01371630 | R/R B-ALL, Ph+ excluded | 1.3-1.8 mg/m2 cycle 1, 1.0-1.3 mg/m2 subsequent cycles, all dosed once per cycle | 59 | 78 (CR + CRp + CRi) | 9/59 | InO combined with mini-HCVD noted to have increased VOD rate |
| Phase 2 combining InO with chemotherapy42 | NCT01371630 | Newly diagnosed B-ALL, Ph+ excluded | 1.3-1.8 mg/m2 cycle 1, 1.0-1.3 mg/m2 subsequent cycles, all dosed once per cycle | 52 | 98 (CR + CRp + CRi) | 4/52 | InO combined with mini-HCVD; first to show high response rate of InO in frontline setting |
| Phase 3 INO-VATE comparing InO with chemotherapy31 | NCT01564784 | R/R B-ALL, Ph+ included | 1.8 mg/m2 per cycle given on days 1, 8, 15; 1.5 mg/m2 once in CR | 326 | 80.7 vs 29.4 | 11% vs 1% | Phase 3 trial that compared single-agent InO to chemotherapy regimens; notably increased rate of VOD |
| Trial . | clinicaltrials.gov identifier . | Disease . | InO schedule . | No. of patients . | CR, % . | VOD . | Notes . |
|---|---|---|---|---|---|---|---|
| Phase 1/230 | NCT01363297 | R/R B-ALL, Ph+ included | 1.2-1.8 mg/m2 per cycle given on days 1, 8, 15; 1.8 for phase 2 | 72 | 68 | 4 | |
| Phase 228,29 | NCT01134575 | R/R B-ALL, Ph+ included | 1.3-1.8 mg/m2 once per cycle (n = 49). 1.8 mg/m2 per cycle given on days 1, 8, 15 (n = 41) | 90 | 58 (CR + CRp + CRi) | 6/90, 6/36 transplant patients | Noted reduced adverse events with weekly dosing |
| Phase 2 combing InO with chemotherapy41 | NCT01371630 | R/R B-ALL, Ph+ excluded | 1.3-1.8 mg/m2 cycle 1, 1.0-1.3 mg/m2 subsequent cycles, all dosed once per cycle | 59 | 78 (CR + CRp + CRi) | 9/59 | InO combined with mini-HCVD noted to have increased VOD rate |
| Phase 2 combining InO with chemotherapy42 | NCT01371630 | Newly diagnosed B-ALL, Ph+ excluded | 1.3-1.8 mg/m2 cycle 1, 1.0-1.3 mg/m2 subsequent cycles, all dosed once per cycle | 52 | 98 (CR + CRp + CRi) | 4/52 | InO combined with mini-HCVD; first to show high response rate of InO in frontline setting |
| Phase 3 INO-VATE comparing InO with chemotherapy31 | NCT01564784 | R/R B-ALL, Ph+ included | 1.8 mg/m2 per cycle given on days 1, 8, 15; 1.5 mg/m2 once in CR | 326 | 80.7 vs 29.4 | 11% vs 1% | Phase 3 trial that compared single-agent InO to chemotherapy regimens; notably increased rate of VOD |
CRp, complete remission with incomplete platelet recovery.