From: A precision medicine classification for treatment of acute myeloid leukemia in older patients
Protocol | Induction | Â | Maintenance |
---|---|---|---|
8321 (n = 3) | Randomized to: *DNR Days 1–3 (45 mg/m2/day < 60 years or 30 mg/m2/day ≥ 60 years) Ara-C Days 1–7 (100 mg/m2/day) VERSUS *DNR Days 1–3 (45 mg/m2/day < 60 years or 30 mg/m2/day ≥ 60 years) Ara-C Days 1–7 (200 mg/m2/day CIV) | 6-TG Days 1–10 (100 mg/m2 PO q12 hour × 10 doses) DNR Day 57 (45 mg/m2/day < 60 years or 30 mg/m2/day ≥ 60 years) Ara-C Days 1–10, 29–38, 57–66, 84–92 (per Induction assignment BID q12 hours × 10 doses) VCR Days 29 and 84 (2 mg/m2 (max 2 mg)) Prednisone Days 29–33, 84–88 (40 mg/m2/day × 5 days) | n/a |
8525 (n = 41) | *DNR Days 1–3 (45 mg/m2/day < 60 years or 30 mg/m2/day ≥ 60 years) Ara-C Days 1–7 (200 mg/m2/day CIV) | Randomized to 4 Cycles: Ara-C Days 1–5 (100 mg/m2/day CIV) VERSUS Days 1–5 (400 mg/m2/day CIV) VERSUS Days 1,3,5 (3gm/m2 every 12 h for 6 total doses) | 4 Cycles: DNR Day 1 (45 mg/m2/day) Ara-C Days 1–5 (100 mg/m2 q12 hours SQ) |
8721 (n = 1) | Ara-C Days 1,2,8,9 (3gm/m2 every 12 h – 8 doses total) L-asparaginase Days 2, 9 (6000 IU/m2) Allowed to repeat on Days 15,16 for both agents if no response | 2 Cycles: Ara-C Days 1,2,8,9 (3gm/m2 every 12 h – 8 doses total) L-asparaginase Days 2, 9 (6000 IU/m2) | n/a |
8821 (n = 1) | *DNR Days 1–3 (45 mg/m2/day) Ara-C Days 1–7 (200 mg/m2/day CIV) | Randomized to Course 1 followed by Course 2 VERSUS Course 2 followed by Course 1: Course 1: (1 cycle) Mitoxantrone Days 1–3 (12 mg/m2/day) Diaziquone Days 1–5 (28 mg/m2/day CIV) Course 2: (1 cycle) Etoposide Day 1 (2400 mg/m2 CIV) Cytoxan Days 3–6 (50 mg/kg/day) | n/a |
8923 (n = 38) | Randomized to: *DNR Days 1–3 (45 mg/m2/day) Ara-C Days 1–7 (200 mg/m2/day CIV) G-CSF Starting Day 8 VERSUS *DNR Days 1–3 (45 mg/m2/day) Ara-C Days 1–7 (200 mg/m2/day CIV) Placebo Starting Day 8 | Course 1: (up to 4 cycles) Ara-C Days 1–5 (100 mg/m2 CIV) Course 2: (up to 2 cycles) Ara-C Days 1–3 (500 mg/m2 q 12 h × 6 doses) Mitoxantrone Days 1–3 (5 mg/m2 × 6 doses) | n/a |
9420 (n = 18) | Randomized to: *DNR Days 1–3 (dose-escalated to MTD 40 mg/m2/day) Etoposide Days 1–3 (dose-escalated to MTD 60 mg/m2/day) Ara-C Days 1–7 (100 mg/m2/day CIV) PSC-833 1.5gm/kg IV Days 1–3 for 2 h, followed by 10 mg/kg/day CIV for 72 h VERSUS *DNR Days 1–3 (dose-escalated to MTD 40 mg/m2/day) Etoposide Days 1–3 (dose-escalated to MTD 60 mg/m2/day) Ara-C Days 1–7 (100 mg/m2/day CIV) No PSC-833 | Randomized to 1 Cycle: DNR Days 1–2 (30 mg/m2/day) Etoposide Days 1–2 (60 mg/m2/day) Ara-C Days 1–5 (100 mg/m2/day CIV) PSC-833 1.5gm/kg IV Days 1–3 for 2 h, followed by 10 mg/kg/day CIV for 72 h VERSUS DNR Days 1–2 (30 mg/m2/day) Etoposide Days 1–2 (60 mg/m2/day) Ara-C Days 1–5 (100 mg/m2/day CIV) No PSC-833 (based on initial induction assignment) | Randomized to: R-IL2 (0.9 × 106 SQ Days 1–14, 19–28, 33–42, 47–56, 61–70, 75–90 and 12 × 106 Day 15–17,29–31, 43–45, 57–59, 71–73) VERSUS No maintenance |
9720 (n = 233) | Randomized to: *DNR Days 1–3 (40 mg/m2/day) Etoposide Days 1–3 (60 mg/m2/day) Ara-C Days 1–7 (100 mg/m2/day CIV) PSC-833 1.5gm/kg IV Days 1–3 for 2 h, followed by 10 mg/kg/day CIV for 72 h VERSUS *DNR Days 1–3 (40 mg/m2/day) Etoposide Days 1–3 (60 mg/m2/day) Ara-C Days 1–7 (100 mg/m2/day CIV) No PSC-833 | Randomized to 1 Cycle: DNR Days 1–2 (30 mg/m2/day) Etoposide Days 1–2 (60 mg/m2/day) Ara-C Days 1–5 (100 mg/m2/day CIV) PSC-833 Days 1–3 (1.5gm/kg IV for 2 h, followed by 10 mg/kg/day CIV for 72 h) VERSUS DNR Days 1–2 (30 mg/m2/day) Etoposide Days 1–2 (60 mg/m2/day) Ara-C Days 1–5 (100 mg/m2/day CIV) No PSC-833 (based on initial induction assignment) | Randomized to: R-IL2 (0.9 × 106 SQ Days 1–14, 19–28, 33–42, 47–56, 61–70, 75–90 and 12 × 106 Day 15–17,29–31, 43–45, 57–59, 71–73) VERSUS No maintenance |
10201 (n = 168) | Randomized to: *DNR Days 4–6 (60 mg/m2/day) Ara-C Days 4–10 (100 mg/m2/day CIV) Oblimersen Days 1–10 (7 mg/kg/day CIV) VERSUS *DNR Days 4–6 (60 mg/m2/day) Ara-C Days 4–10 (100 mg/m2/day CIV) No Oblimersen | Randomized to 2 Cycles: Ara-C Days 4–8 (2000 mg/m2/daily) Oblimersen Days 1–8 (7 mg/kg/day CIV) VERSUS Ara-C Days 4–8 (2000 mg/m2/daily) No Oblimersen | n/a |
10502 (n = 35) | *DNR Days 1–3 (60 mg/m2/day) Ara-C Days 1–7 (100 mg/m2/day CIV) Bortezomib 1.3 mg/m2 Days 1,4,8,11 | 2 Cycles: Ara-C Days 1–5 (2gm/m2/day) Bortezomib per dose escalation Days 1,4,8,11 | n/a |
10801 (n = 13) | *DNR Days 1–3 (60 mg/m2/day) Ara-C Days 1–7 (200 mg/m2/day CIV) Dasatinib Days 8–21 (100 mg PO Daily) | 4 cycles: Ara-C Days 1,3,5 (3 gm/m2 q12 hours < 60 years and 1gm/m2 q12 hours ≥ 60 years) Dasatinib Days 1–26 (100 mg PO daily) | Dasatinib 100 mg PO daily up to 12 months |
11001 (n = 11) | *DNR Days 1–3 (60 mg/m2/day) Ara-C Days 1–7 (100 mg/m2/day CIV) Sorafenib Days 1–7 (400 mg daily) | 2 Cycles: Ara-C Days 1–5 (2 gm/m2/day) Sorafenib Days 1–28 (400 mg PO BID) | Sorafenib 400 mg PO BID Days 1–28 up to 12 cycles |