Selected ongoing trials
| Trial . | clinicaltrials.gov identifier . | Disease . | InO schedule . | Patients . | Open . | Notes . |
|---|---|---|---|---|---|---|
| Phase 1/2 testing safety and efficacy of bosutinib and InO | NCT02311998 | R/R Ph+ B-ALL, CML in lymphoid blast phase | 1.8 mg/m2 per cycle given on days 1, 8, 15 | Adults 18+ y | Recruiting | Trial to formally evaluate MTD of TKI and InO |
| Phase 3 A041501: (C10403 ± InO) | NCT03150693 | Newly diagnosed B-ALL | 1.8 mg/m2 per cycle given on days 1, 8, 15 | Adults 18-39 y | Recruiting | Trial to test the addition of InO to improve frontline therapy in AYA patients |
| Phase 2 hyper-CVAD + InO | NCT03488225 | Newly diagnosed B-ALL, Ph+ excluded | 0.6 mg/m2 day 1 and 0.3 mg/m2 day 8 of cycles 5-8 | 16 y and older | Recruiting | Plan to test addition of InO to hyper-CVAD backbone |
| Phase 2 testing InO for MRD | NCT03441061 | B-ALL, Ph+ excluded, in CR with MRD+ | 0.6 mg/m2 day 1 and 0.3 mg/m2 days 8 and 15 | Adults | Recruiting | Plan to the tolerability and efficacy of using InO to eliminate MRD+ disease. |
| Phase 2 testing low-dose InO in relapsed disease | NCT03094611 | R/R B-ALL, Ph+ excluded | Cycle 1: 0.8 mg/m2 day 1 and 0.5 mg/m2 days 8 and 15 Subsequent cycles: 0.6 mg/m2 day 1, 0.3 mg/m2 day 8, | 12 y and older | Recruiting | Plan to test efficacy and tolerability of a reduced dosing schedule for R/R disease |
| Randomized phase 2 in DLBCL patients ineligible for anthracyclines | NCT01679119 | Frontline DLBCL, not anthracycline candidates | 0.8 mg/m2 day 2 | Adult | Recruiting | Testing replacement of anthracycline by either InO or gemcitabine to R-CHOP regimen in patients who cannot safely receive standard treatment |
| Trial . | clinicaltrials.gov identifier . | Disease . | InO schedule . | Patients . | Open . | Notes . |
|---|---|---|---|---|---|---|
| Phase 1/2 testing safety and efficacy of bosutinib and InO | NCT02311998 | R/R Ph+ B-ALL, CML in lymphoid blast phase | 1.8 mg/m2 per cycle given on days 1, 8, 15 | Adults 18+ y | Recruiting | Trial to formally evaluate MTD of TKI and InO |
| Phase 3 A041501: (C10403 ± InO) | NCT03150693 | Newly diagnosed B-ALL | 1.8 mg/m2 per cycle given on days 1, 8, 15 | Adults 18-39 y | Recruiting | Trial to test the addition of InO to improve frontline therapy in AYA patients |
| Phase 2 hyper-CVAD + InO | NCT03488225 | Newly diagnosed B-ALL, Ph+ excluded | 0.6 mg/m2 day 1 and 0.3 mg/m2 day 8 of cycles 5-8 | 16 y and older | Recruiting | Plan to test addition of InO to hyper-CVAD backbone |
| Phase 2 testing InO for MRD | NCT03441061 | B-ALL, Ph+ excluded, in CR with MRD+ | 0.6 mg/m2 day 1 and 0.3 mg/m2 days 8 and 15 | Adults | Recruiting | Plan to the tolerability and efficacy of using InO to eliminate MRD+ disease. |
| Phase 2 testing low-dose InO in relapsed disease | NCT03094611 | R/R B-ALL, Ph+ excluded | Cycle 1: 0.8 mg/m2 day 1 and 0.5 mg/m2 days 8 and 15 Subsequent cycles: 0.6 mg/m2 day 1, 0.3 mg/m2 day 8, | 12 y and older | Recruiting | Plan to test efficacy and tolerability of a reduced dosing schedule for R/R disease |
| Randomized phase 2 in DLBCL patients ineligible for anthracyclines | NCT01679119 | Frontline DLBCL, not anthracycline candidates | 0.8 mg/m2 day 2 | Adult | Recruiting | Testing replacement of anthracycline by either InO or gemcitabine to R-CHOP regimen in patients who cannot safely receive standard treatment |
AYA, adolescent and young adult; CML, chronic myeloid leukemia; hyper-CVAD, cyclophosphamide, vincristine, doxorubicin (Adriamycin), and dexamethasone.