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Table 1 CALGB Protocol Chemotherapy Regimens

From: A precision medicine classification for treatment of acute myeloid leukemia in older patients

Protocol Induction   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
  1. Ara-C, cytarabine; BID, twice daily; CIV, continuous intravenous infusion; DNR, daunorubicin; gm, gram; h, hour; IU, international units; kg, kilogram; m, meter; mg, milligram; MTD, maximum tolerated dose; n, number; n/a, not applicable; PO, orally; q12, every 12; SQ, subcutaneous; VCR, vincristine; 6-TG, 6-Thioguanine
  2. *Reinduction therapy allowed