Primary end points in ongoing randomized adult ALL trials
| NCT identifier . | Treatments . | ALL status . | Age, y . | Primary end point . |
|---|---|---|---|---|
| Phase 2 | ||||
| NCT05748171 | Inotuzumab ozogamcin vs ALLR3 chemotherapy | First relapse | 1-18 | MRD negativity in participants achieving CR, complete response with incomplete platelet count recovery (CRp), or complete response with incomplete count recovery (CRi) |
| NCT05082519 | Caloric restriction (to reduce chemotherapy resistance) vs none | Untreated | 10-25 | End induction MRD positivity |
| NCT04920968 (PALG ALL7) | Obinatuzumab + chemotherapy vs rituximab + chemotherapy | Untreated | 18+ | End induction MRD-negative CR rate |
| NCT05303792 (A042001) | Inotuzumab ozogamicin + lower dose chemotherapy vs age-adjusted chemotherapy | Untreated | 50+ | EFS including failure to achieve MRD-negative CR, 2-mo |
| Phase 3 | ||||
| NCT04307576 (ALLTogether) | Multiple agents/randomizations | Untreated | 0-45 | EFS, 5-y |
| NCT02881086 (GMALL08) | CNS irradiation in combination with intrathecal therapy vs intrathecal therapy and allogeneic HCT vs chemotherapy | Untreated | 18-55 | EFS, 3.5-y |
| NCT03821610 (ALL-RIC) | Total body irradiation/cyclophosphamide vs fludarabine/melphalan conditioning | Untreated | 40-70 | DFS, 2 y, transplant study |
| NCT03959085 (AALL1732) | Inotuzumab ozogamicin + mBFM(-DI2) vs mBFM | Untreated | 1-25 | DFS, 5-y from end of consolidation |
| NCT02611492 (GRAAPH2014) | Nilotinib + SD chemotherapy/HCT vs nilotinib + RI chemotherapy/HCT | Untreated | 18-59 | Major molecular response at 4 mo |
| NCT04722848 (ALL2820) | Ponatinib + blinatumomab vs imatinib + chemotherapy | Untreated | 18+ | EFS, 5 mo |
| NCT04530565 (EA9181) | Steroids + TKI + blinatumomab induction vs steroids + TKI + chemotherapy induction | Untreated | 18-75 | OS |
| NCT03150693 (A041501) | Inotuzumab ozogamicin + chemotherapy vs chemotherapy | Untreated | 18-39 | EFS, 3-y |
| NCT04994717 (Golden Gate) | Blinatumumab + low-intensity chemotherapy vs standard chemotherapy | Untreated | 40-100 | EFS, including failure to achieve MRD-negative CR, 5-y; and OS, 5-y |
| NCT identifier . | Treatments . | ALL status . | Age, y . | Primary end point . |
|---|---|---|---|---|
| Phase 2 | ||||
| NCT05748171 | Inotuzumab ozogamcin vs ALLR3 chemotherapy | First relapse | 1-18 | MRD negativity in participants achieving CR, complete response with incomplete platelet count recovery (CRp), or complete response with incomplete count recovery (CRi) |
| NCT05082519 | Caloric restriction (to reduce chemotherapy resistance) vs none | Untreated | 10-25 | End induction MRD positivity |
| NCT04920968 (PALG ALL7) | Obinatuzumab + chemotherapy vs rituximab + chemotherapy | Untreated | 18+ | End induction MRD-negative CR rate |
| NCT05303792 (A042001) | Inotuzumab ozogamicin + lower dose chemotherapy vs age-adjusted chemotherapy | Untreated | 50+ | EFS including failure to achieve MRD-negative CR, 2-mo |
| Phase 3 | ||||
| NCT04307576 (ALLTogether) | Multiple agents/randomizations | Untreated | 0-45 | EFS, 5-y |
| NCT02881086 (GMALL08) | CNS irradiation in combination with intrathecal therapy vs intrathecal therapy and allogeneic HCT vs chemotherapy | Untreated | 18-55 | EFS, 3.5-y |
| NCT03821610 (ALL-RIC) | Total body irradiation/cyclophosphamide vs fludarabine/melphalan conditioning | Untreated | 40-70 | DFS, 2 y, transplant study |
| NCT03959085 (AALL1732) | Inotuzumab ozogamicin + mBFM(-DI2) vs mBFM | Untreated | 1-25 | DFS, 5-y from end of consolidation |
| NCT02611492 (GRAAPH2014) | Nilotinib + SD chemotherapy/HCT vs nilotinib + RI chemotherapy/HCT | Untreated | 18-59 | Major molecular response at 4 mo |
| NCT04722848 (ALL2820) | Ponatinib + blinatumomab vs imatinib + chemotherapy | Untreated | 18+ | EFS, 5 mo |
| NCT04530565 (EA9181) | Steroids + TKI + blinatumomab induction vs steroids + TKI + chemotherapy induction | Untreated | 18-75 | OS |
| NCT03150693 (A041501) | Inotuzumab ozogamicin + chemotherapy vs chemotherapy | Untreated | 18-39 | EFS, 3-y |
| NCT04994717 (Golden Gate) | Blinatumumab + low-intensity chemotherapy vs standard chemotherapy | Untreated | 40-100 | EFS, including failure to achieve MRD-negative CR, 5-y; and OS, 5-y |
CNS, central nervous system; mBFM, modified Berlin-Frankfurt-Munich; NCT, National Clinical Trial; RI, reduced intensity; SD, standard dose.