Patient characteristics
| UPN . | Patient age, y/sex . | Diagnosis status before G3139 . | Major cytogenetic aberration at diagnosis and, in brackets, before G3139 . | Duration first CR, mo . | Previous treatments . | Previous HiDAC . | Response . | Disease status (d) . | Dose level . |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 55/F | Primary REF AML | +15 | NA | 3 | Yes | CR* | REL (142) | 1 |
| 2 | 61/F | 1st REL AML | Normal [add(2)(q37)] | 6 | 2 | No | NR | REF | 1 |
| 3 | 54/M | Primary REF AML | Normal | NA | 1 | No | NR | REF | 1 |
| 4 | 57/F | 2nd REL AML | Normal | 12 | 2 | Yes | CR* | REL (564) | 2 |
| 5 | 23/M | 1st REL AML | t(8;11)(q22;p1?5) | 3 | 1 | Yes | IR† | REL (83) | 2 |
| 6 | 73/F | 2nd REL AML | Normal | 8 | 2 | Yes | NR | REF | 2 |
| 7 | 69/F | Primary REF ALL | t(9;22)(q34;q11.2) complex | NA | 1 | Yes | CR* | REL (122) | 3 |
| 8 | 61/F | 1st REL AML | Normal | 7 | 1 | No | IR† | REL (134) | 3 |
| 9 | 55/F | 2nd REL AML | inv(3)(q21q26), −7 | 6 | 3 | Yes | NR | REF | 3 |
| 10 | 39/M | 2nd REL AML | ?ins(8;21)(q22;q22q22), −Y | 3 | 2 | Yes | NE | REF | 3 |
| 11 | 71/F | 1st REL AML | del(7)(q11.2) | 17 | 1 | No | CR* | REL (382) | 4 |
| 12 | 59/F | Primary REF ALL | t(9;22)(q34;q11.2) | NA | 1 | Yes | NR | REF | 4 |
| 13 | 49/M | Primary REF AML | −14, del(6)(q21) [complex] | NA | 1 | No | NR | REF | 4 |
| 14 | 78/M | Primary REF AML | inv(3)(q21q26), del(7)(q11.1) | NA | 4 | No | NE | REF | 4 |
| 15 | 62/F | 1st REL AML | Normal | 12 | 1 | No | CR* | NED‡ (94) | 5 |
| 16 | 18/M | 1st REL ALL | t(5;14)(q31;q32) | 21 | 1 | Yes | CR* | CNS REL (7) | 5 |
| 17 | 51/F | 1st REL AML | Normal [-X] | 12 | 1 | No | CR* | NED‡ (120) | 5 |
| 18 | 33/F | 1st REL AML after MUD BMT | Diagnostic unknown [del(5)(q31),+21] | 12 | 3 | No | NR | REF | 5 |
| 19 | 49/F | Primary REF AML | −7 | NA | 1 | No | NR | REF | 5 |
| 20 | 51/M | 1st REL AML | Diagnostic unknown [t(6;7)(p10;p10)] | 5 | 1 | No | NR | REF | 5 |
| UPN . | Patient age, y/sex . | Diagnosis status before G3139 . | Major cytogenetic aberration at diagnosis and, in brackets, before G3139 . | Duration first CR, mo . | Previous treatments . | Previous HiDAC . | Response . | Disease status (d) . | Dose level . |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 55/F | Primary REF AML | +15 | NA | 3 | Yes | CR* | REL (142) | 1 |
| 2 | 61/F | 1st REL AML | Normal [add(2)(q37)] | 6 | 2 | No | NR | REF | 1 |
| 3 | 54/M | Primary REF AML | Normal | NA | 1 | No | NR | REF | 1 |
| 4 | 57/F | 2nd REL AML | Normal | 12 | 2 | Yes | CR* | REL (564) | 2 |
| 5 | 23/M | 1st REL AML | t(8;11)(q22;p1?5) | 3 | 1 | Yes | IR† | REL (83) | 2 |
| 6 | 73/F | 2nd REL AML | Normal | 8 | 2 | Yes | NR | REF | 2 |
| 7 | 69/F | Primary REF ALL | t(9;22)(q34;q11.2) complex | NA | 1 | Yes | CR* | REL (122) | 3 |
| 8 | 61/F | 1st REL AML | Normal | 7 | 1 | No | IR† | REL (134) | 3 |
| 9 | 55/F | 2nd REL AML | inv(3)(q21q26), −7 | 6 | 3 | Yes | NR | REF | 3 |
| 10 | 39/M | 2nd REL AML | ?ins(8;21)(q22;q22q22), −Y | 3 | 2 | Yes | NE | REF | 3 |
| 11 | 71/F | 1st REL AML | del(7)(q11.2) | 17 | 1 | No | CR* | REL (382) | 4 |
| 12 | 59/F | Primary REF ALL | t(9;22)(q34;q11.2) | NA | 1 | Yes | NR | REF | 4 |
| 13 | 49/M | Primary REF AML | −14, del(6)(q21) [complex] | NA | 1 | No | NR | REF | 4 |
| 14 | 78/M | Primary REF AML | inv(3)(q21q26), del(7)(q11.1) | NA | 4 | No | NE | REF | 4 |
| 15 | 62/F | 1st REL AML | Normal | 12 | 1 | No | CR* | NED‡ (94) | 5 |
| 16 | 18/M | 1st REL ALL | t(5;14)(q31;q32) | 21 | 1 | Yes | CR* | CNS REL (7) | 5 |
| 17 | 51/F | 1st REL AML | Normal [-X] | 12 | 1 | No | CR* | NED‡ (120) | 5 |
| 18 | 33/F | 1st REL AML after MUD BMT | Diagnostic unknown [del(5)(q31),+21] | 12 | 3 | No | NR | REF | 5 |
| 19 | 49/F | Primary REF AML | −7 | NA | 1 | No | NR | REF | 5 |
| 20 | 51/M | 1st REL AML | Diagnostic unknown [t(6;7)(p10;p10)] | 5 | 1 | No | NR | REF | 5 |
UPNs 16 and 17 were taken off study at day 6 because the blast count increased to more than 100 000/μL.
HiDAC indicates high-dose ARA-C; REF, refractory; NA, not applicable; REL, relapse; NR, no response; NE, not evaluable; and NED, no evidence of disease.
Complete remission with BM less than 5% blasts, ANC more than 1500/μL, and platelets more than 100 000/μL.
Incomplete remission with BM less than 5% blasts, ANC less than 1500/μL, or platelets less than 100 000/μL.
Dead.