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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