Clinical trials for patients with Ph-like ALL
| Study group . | Trial name/phase . | Years . | Age group, y . | Genetic subgroups . | TKI . | Status . |
|---|---|---|---|---|---|---|
| COG | AALL1131/phase 3 (NCT01406756) | 2016-2019 | >1-30.99 | De novo ABL-class Ph-like B-ALL | dasatinib | Closed to accrual—pending results |
| COG | AALL1521/phase 2 (NCT02723994) | 2016-present | ≥1-21 | De novo JAK-STAT pathway-altered NCI high-risk Ph-like ALL | ruxolitinib | Cohort A: CRLF2-R and JAK+ with EOI MRD ≥0.01%—open to accrual Cohort B: CRLF2-R and JAK– with EOI MRD ≥0.01%—open to accrual Cohort C: JAK2-R, EPOR-R, and SH2B3 mutations and IL7R mutations with EOI MRD ≥0.01%—closed to accrual Cohort D: patients eligible for cohort A, B, or C with EOI MRD <0.01%—closed to accrual |
| EsPhALL + COG | EsPhALL2017/AALL1631/phase 3 (NCT03007147) | 2017-present | >1-21 | De novo Ph+ or ABL-class Ph-like ALL | Imatinib | Active |
| COG | AALL1922/phase 1/2 (NCT04501614) | 2020-present | ≥1-21 | Relapsed/refractory Ph+ or ABL-class Ph-like ALL | Ponatinib | Active |
| COG | ADVL1823/phase 2 (NCT03834961) | 2019-present | 0-≤30 | Relapsed/refractory acute leukemia with NTRK1/2/3 fusions | Larotrectinib | Cohort C—active |
| DFCI | DFCI ALL 16-001/phase 3 (NCT03040030) | 2017-present | ≥1-21 | De novo VHR B-ALL with ABL-class fusions other than BCR-ABL1 | Dasatinib | Active |
| SJCRH | Total Therapy XVII/phase 2/3 (NCT03117751) | 2017-present | ≥1-18 | De novo B-ALL with ABL-class fusions or JAK-STAT pathway mutations | Dasatinib, ruxolitinib | Active |
| ALLTogether | ALLTogether 01/phase 3 (NCT03911128) | 2019-present | ≥1-45 | De novo Ph-like ABL-class B-ALL | Imatinib | Active |
| MDACC | 2014-0521/phase 1/2 (NCT02420717) | 2015-2021 | ≥10 | relapsed/refractory Ph-like ALL with ABL-class or JAK-STAT pathway alterations | Dasatinib, ruxolitinib | Closed to accrual |
| University of Chicago | IRB17-1110/phase 1 (NCT03571321) | 2019-present | ≥18-39.99 | De novo Ph-like ALL harboring JAK-STAT pathway alterations | Ruxolitinib | Active |
| SWOG | S1318/phase 2 (NCT02143414) | 2015-2017 | ≥65 | De novo B-ALL with ABL-class fusions including BCR-ABL1 | Dasatinib | Cohort 2—closed to accrual |
| Study group . | Trial name/phase . | Years . | Age group, y . | Genetic subgroups . | TKI . | Status . |
|---|---|---|---|---|---|---|
| COG | AALL1131/phase 3 (NCT01406756) | 2016-2019 | >1-30.99 | De novo ABL-class Ph-like B-ALL | dasatinib | Closed to accrual—pending results |
| COG | AALL1521/phase 2 (NCT02723994) | 2016-present | ≥1-21 | De novo JAK-STAT pathway-altered NCI high-risk Ph-like ALL | ruxolitinib | Cohort A: CRLF2-R and JAK+ with EOI MRD ≥0.01%—open to accrual Cohort B: CRLF2-R and JAK– with EOI MRD ≥0.01%—open to accrual Cohort C: JAK2-R, EPOR-R, and SH2B3 mutations and IL7R mutations with EOI MRD ≥0.01%—closed to accrual Cohort D: patients eligible for cohort A, B, or C with EOI MRD <0.01%—closed to accrual |
| EsPhALL + COG | EsPhALL2017/AALL1631/phase 3 (NCT03007147) | 2017-present | >1-21 | De novo Ph+ or ABL-class Ph-like ALL | Imatinib | Active |
| COG | AALL1922/phase 1/2 (NCT04501614) | 2020-present | ≥1-21 | Relapsed/refractory Ph+ or ABL-class Ph-like ALL | Ponatinib | Active |
| COG | ADVL1823/phase 2 (NCT03834961) | 2019-present | 0-≤30 | Relapsed/refractory acute leukemia with NTRK1/2/3 fusions | Larotrectinib | Cohort C—active |
| DFCI | DFCI ALL 16-001/phase 3 (NCT03040030) | 2017-present | ≥1-21 | De novo VHR B-ALL with ABL-class fusions other than BCR-ABL1 | Dasatinib | Active |
| SJCRH | Total Therapy XVII/phase 2/3 (NCT03117751) | 2017-present | ≥1-18 | De novo B-ALL with ABL-class fusions or JAK-STAT pathway mutations | Dasatinib, ruxolitinib | Active |
| ALLTogether | ALLTogether 01/phase 3 (NCT03911128) | 2019-present | ≥1-45 | De novo Ph-like ABL-class B-ALL | Imatinib | Active |
| MDACC | 2014-0521/phase 1/2 (NCT02420717) | 2015-2021 | ≥10 | relapsed/refractory Ph-like ALL with ABL-class or JAK-STAT pathway alterations | Dasatinib, ruxolitinib | Closed to accrual |
| University of Chicago | IRB17-1110/phase 1 (NCT03571321) | 2019-present | ≥18-39.99 | De novo Ph-like ALL harboring JAK-STAT pathway alterations | Ruxolitinib | Active |
| SWOG | S1318/phase 2 (NCT02143414) | 2015-2017 | ≥65 | De novo B-ALL with ABL-class fusions including BCR-ABL1 | Dasatinib | Cohort 2—closed to accrual |
CRLF2-R, CRLF2-rearranged; DFCI, Dana-Farber Cancer Institute; EOI, end of induction; EPOR-R, EPOR-rearranged; JAK+, JAK2- or JAK1-mutated; JAK–, JAK2 and JAK1 wild-type; JAK2-R, JAK2-rearranged; MDACC, MD Anderson Cancer Center; SJCRH, St Jude Children's Research Hospital; SWOG, Southwest Oncology Group; VHR, very high risk.