Trials using nelarabine for adult T-ALL
| Study . | Years of accrual . | N . | Age of cohort, years . | Phase of trial . | Patient population . | Nelarabine dose . | Outcome . |
|---|---|---|---|---|---|---|---|
| COG | 1997-2002 | 153 | 0.6-21.7 | Phase 2 | R/R T-ALL/LLy | 650 mg/m2 IV, days 1-5 | ORR: 33% First salvage RR: 55% |
| CALGB 19801 | 1998-2001 | 39 | 16-66 | Phase 2 | R/R T-ALL/LLy | 1500 mg/m2 IV, days 1, 3, 5 | CR+CRi rate: 31% 1-y OS: 28% |
| GMALL | 2001-2008 | 126 | 18-81 | Phase 2 | R/R T-ALL/LLy | 1500 mg/m2 IV, days 1, 3, 5 | CR rate: 36% 1-y OS: 24% |
| CAMPUS ALL | 2007-2018 | 118 | 18-74 | Phase 4 | R/R T-ALL/LLy | 1500 mg/m2 IV, days 1, 3, 5 | CR rate: 36% 1-y OS: 38% |
| COG AALL0434 | 2007-2014 | 1895 | 1-30 | Phase 3 RCT | Frontline T-ALL/LLy | 650 mg/m2 IV, days 1-5 for 6 total courses | 5-y DFS: 82% aBFM 5-y DFS: 88% aBFM + N CNS RR: 6.9% aBFM CNS RR: 1.3% aBFM + N |
| MDACC | 2007-2016 | 67 | 18-78 | Phase 2 | Frontline T-ALL/LLy | 650 mg/m2 IV, days 1-5 for 4 total courses | 3-y CRD: 66% 3-y OS: 65% RR: 31% |
| UKALL14 NCT01085617 | 2012-2018 | 144 | 25-65 | Phase 3 RCT | Frontline | 1500 mg/m2 IV, days 1, 3, 5 for 1 postremission course | 3-y EFS: 57% SOC 3-y EFS: 62% SOC + N 3-y OS: 62% SOC 3-y OS: 66% SOC + N 3-y RR: 29% SOC 3-y RR: 28% SOC + N |
| GRAALL-2014/T NCT02619630 | 2015-2020 | 275 | 18-59 | Phase 2 | Frontline | 1500 mg/m2 IV, days 1, 3, 5 for 5 postremission courses | Primary end point: 4-y DFS Ongoing study |
| Study . | Years of accrual . | N . | Age of cohort, years . | Phase of trial . | Patient population . | Nelarabine dose . | Outcome . |
|---|---|---|---|---|---|---|---|
| COG | 1997-2002 | 153 | 0.6-21.7 | Phase 2 | R/R T-ALL/LLy | 650 mg/m2 IV, days 1-5 | ORR: 33% First salvage RR: 55% |
| CALGB 19801 | 1998-2001 | 39 | 16-66 | Phase 2 | R/R T-ALL/LLy | 1500 mg/m2 IV, days 1, 3, 5 | CR+CRi rate: 31% 1-y OS: 28% |
| GMALL | 2001-2008 | 126 | 18-81 | Phase 2 | R/R T-ALL/LLy | 1500 mg/m2 IV, days 1, 3, 5 | CR rate: 36% 1-y OS: 24% |
| CAMPUS ALL | 2007-2018 | 118 | 18-74 | Phase 4 | R/R T-ALL/LLy | 1500 mg/m2 IV, days 1, 3, 5 | CR rate: 36% 1-y OS: 38% |
| COG AALL0434 | 2007-2014 | 1895 | 1-30 | Phase 3 RCT | Frontline T-ALL/LLy | 650 mg/m2 IV, days 1-5 for 6 total courses | 5-y DFS: 82% aBFM 5-y DFS: 88% aBFM + N CNS RR: 6.9% aBFM CNS RR: 1.3% aBFM + N |
| MDACC | 2007-2016 | 67 | 18-78 | Phase 2 | Frontline T-ALL/LLy | 650 mg/m2 IV, days 1-5 for 4 total courses | 3-y CRD: 66% 3-y OS: 65% RR: 31% |
| UKALL14 NCT01085617 | 2012-2018 | 144 | 25-65 | Phase 3 RCT | Frontline | 1500 mg/m2 IV, days 1, 3, 5 for 1 postremission course | 3-y EFS: 57% SOC 3-y EFS: 62% SOC + N 3-y OS: 62% SOC 3-y OS: 66% SOC + N 3-y RR: 29% SOC 3-y RR: 28% SOC + N |
| GRAALL-2014/T NCT02619630 | 2015-2020 | 275 | 18-59 | Phase 2 | Frontline | 1500 mg/m2 IV, days 1, 3, 5 for 5 postremission courses | Primary end point: 4-y DFS Ongoing study |
CALGB, Cancer and Leukemia Group B; CRD, complete remission duration; GMALL, German Multicenter Study Group for Adult ALL; N, nelarabine.