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Systemic Anti-Cancer Therapy Regimen Library

Home > LEU AML - DA+GO-2 [DAUNOrubicin, cytarabine and Mylotarg [gemtuzumab ozogamicin]] induction [de novo CD33+] [good or intermediate risk]

LEU AML - DA+GO-2 [DAUNOrubicin, cytarabine and Mylotarg [gemtuzumab ozogamicin]] induction [de novo CD33+] [good or intermediate risk]

Treatment Overview

Frequency: Every 28 days or on count recovery.

Number of cycles: 1.

Cycle 1 - 28 days

Cycle length:
28

Mylotarg® (gemtuzumab ozogamicin): Should NOT be given if white cell count is above 30 x 109/L. Administration must be delayed to Day 4 and 7.

Liver function tests must NOT exceed twice the upper limit of normal range.  

Cycle details

Cycle 1 - 28 days

Medication Dose Route Days Max Duration
loratadine * 10 mg oral administration 1, 4
paracetamol * 1000 mg flat dosing oral administration 1, 4
methylprednisolone * 50 mg intravenous 1, 4 1 minutes
Mylotarg * 3 mg/m² Cap dose per administration at: 5 mg intravenous 1, 4 120 minutes
DAUNOrubicin * 60 mg/m² Once daily intravenous 1, 3, 5 60 minutes Min: 60 minutes
cytarabine 100 mg/m² Twice daily intravenous 1 to 10 15 minutes

Mylotarg® (gemtuzumab ozogamicin): Should NOT be given if white cell count is above 30 x 109/L. Administration must be delayed to Day 4 and 7.

Liver function tests must NOT exceed twice the upper limit of normal range.  

Full details

Cycle 1 - 28 days

Day: 1

Medication Dose Route Max duration Details
loratadine * 10 mg oral administration
Instructions:

30 to 60 minutes prior to Mylotarg®, or as per institutional practice.
paracetamol * 1000 mg flat dosing oral administration
Instructions:

30 to 60 minutes prior to Mylotarg®, or as per institutional practice.
methylprednisolone * 50 mg intravenous 1 minutes
Instructions:

30 to 60 minutes prior to Mylotarg®, or as per institutional practice.
Mylotarg * 3 mg/m² Cap dose per administration at: 5 mg intravenous 120 minutes
Instructions:
  • Mylotarg® (gemtuzumab ozogamicin).
  • If white cell count is above 30 x 109/L administration must be delayed to Days 4 and 7. 
  • Administer with an in-line, low protein-binding 0.2 micron polyethersulphone (PES) filter. Protect infusion bag from light. 
DAUNOrubicin * 60 mg/m² Once daily intravenous 60 minutes Min: 60 minutes
Instructions:

Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.

cytarabine 100 mg/m² Twice daily intravenous 15 minutes
Instructions:

Every 12 hours.

Day: 2

Medication Dose Route Max duration Details
cytarabine 100 mg/m² Twice daily intravenous 15 minutes
Instructions:

Every 12 hours.

Day: 3

Medication Dose Route Max duration Details
DAUNOrubicin * 60 mg/m² Once daily intravenous 60 minutes Min: 60 minutes
Instructions:

Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.

cytarabine 100 mg/m² Twice daily intravenous 15 minutes
Instructions:

Every 12 hours.

Day: 4

Medication Dose Route Max duration Details
loratadine * 10 mg oral administration
Instructions:

30 to 60 minutes prior to Mylotarg®, or as per institutional practice.
paracetamol * 1000 mg flat dosing oral administration
Instructions:

30 to 60 minutes prior to Mylotarg®, or as per institutional practice.
methylprednisolone * 50 mg intravenous 1 minutes
Instructions:

30 to 60 minutes prior to Mylotarg®, or as per institutional practice.
Mylotarg * 3 mg/m² Cap dose per administration at: 5 mg intravenous 120 minutes
Instructions:
  • Mylotarg® (gemtuzumab ozogamicin).
  • If white cell count is above 30 x 109/L administration must be delayed to Days 4 and 7. 
  • Administer with an in-line, low protein-binding 0.2 micron polyethersulphone (PES) filter. Protect infusion bag from light. 
cytarabine 100 mg/m² Twice daily intravenous 15 minutes
Instructions:

Every 12 hours.

Day: 5

Medication Dose Route Max duration Details
DAUNOrubicin * 60 mg/m² Once daily intravenous 60 minutes Min: 60 minutes
Instructions:

Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.

cytarabine 100 mg/m² Twice daily intravenous 15 minutes
Instructions:

Every 12 hours.

Day: 6

Medication Dose Route Max duration Details
cytarabine 100 mg/m² Twice daily intravenous 15 minutes
Instructions:

Every 12 hours.

Day: 7

Medication Dose Route Max duration Details
cytarabine 100 mg/m² Twice daily intravenous 15 minutes
Instructions:

Every 12 hours.

Day: 8

Medication Dose Route Max duration Details
cytarabine 100 mg/m² Twice daily intravenous 15 minutes
Instructions:

Every 12 hours.

Day: 9

Medication Dose Route Max duration Details
cytarabine 100 mg/m² Twice daily intravenous 15 minutes
Instructions:

Every 12 hours.

Day: 10

Medication Dose Route Max duration Details
cytarabine 100 mg/m² Twice daily intravenous 15 minutes
Instructions:

Every 12 hours.

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Routine antifungal prophylaxis recommended
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Emetogenicity: Variable
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis is recommended

Antifungal prophylaxis: Prophylaxis with azole antifungals should be withheld whilst being treated with Mylotarg® (gemtuzumab ozogamicin) and for 5 days after the last dose (due to risk of sinusoidal obstruction syndrome).

Antiviral prophylaxis for hepatitis B virus: Guidance is limited to high-risk anti-cancer medicines. Clinicians will need to assess individual patient risk for other anti-cancer medicines.

Emetogenicity: MEDIUM days 1, 3 and 5; LOW days 2, 4, 6, 7, 8, 9 and 10.

References

Pfizer New Zealand Ltd. Mylotarg® data sheet 14 February 2022 https://www.medsafe.govt.nz/profs/Datasheet/m/mylotarginj.pdf (accessed 12 July 2022).

Burnett AK, Russell NH, Hills RK, Kell J, Cavenagh J, Kjeldsen L, McMullin MF, Cahalin P, Dennis M, Friis L, Thomas IF, Milligan D, Clark RE; UK NCRI AML Study Group. A randomized comparison of daunorubicin 90 mg/m2 vs 60 mg/m2 in AML induction: results from the UK NCRI AML17 trial in 1206 patients. Blood. 2015 Jun 18;125(25):3878-85. doi: 10.1182/blood-2015-01-623447. Epub 2015 Apr 1., PMID: 25833957

Castaigne S, Pautas C, Terré C, Raffoux E, Bordessoule D, Bastie JN, Legrand O, Thomas X, Turlure P, Reman O, de Revel T, Gastaud L, de Gunzburg N, Contentin N, Henry E, Marolleau JP, Aljijakli A, Rousselot P, Fenaux P, Preudhomme C, Chevret S, Dombret H; Acute Leukemia French Association. Effect of gemtuzumab ozogamicin on survival of adult patients with de-novo acute myeloid leukaemia (ALFA-0701): a randomised, open-label, phase 3 study. Lancet. 2012 Apr 21;379(9825):1508-16. doi: 10.1016/S0140-6736(12)60485-1. Epub 2012 Apr 5. Erratum in: Lancet. 2018 Feb 8., PMID: 22482940

Lambert J, Pautas C, Terré C, Raffoux E, Turlure P, Caillot D, Legrand O, Thomas X, Gardin C, Gogat-Marchant K, Rubin SD, Benner RJ, Bousset P, Preudhomme C, Chevret S, Dombret H, Castaigne S. Gemtuzumab ozogamicin for de novo acute myeloid leukemia: final efficacy and safety updates from the open-label, phase III ALFA-0701 trial. Haematologica. 2019 Jan;104(1):113-119. doi: 10.3324/haematol.2018.188888. Epub 2018 Aug 3., PMID: 30076173

Hills RK, Castaigne S, Appelbaum FR, Delaunay J, Petersdorf S, Othus M, Estey EH, Dombret H, Chevret S, Ifrah N, Cahn JY, Récher C, Chilton L, Moorman AV, Burnett AK. Addition of gemtuzumab ozogamicin to induction chemotherapy in adult patients with acute myeloid leukaemia: a meta-analysis of individual patient data from randomised controlled trials. Lancet Oncol. 2014 Aug;15(9):986-96. doi: 10.1016/S1470-2045(14)70281-5. Epub 2014 Jul 6., PMID: 25008258

Burnett AK, Hills RK, Milligan D, Kjeldsen L, Kell J, Russell NH, Yin JA, Hunter A, Goldstone AH, Wheatley K. Identification of patients with acute myeloblastic leukemia who benefit from the addition of gemtuzumab ozogamicin: results of the MRC AML15 trial. J Clin Oncol. 2011 Feb 1;29(4):369-77. doi: 10.1200/JCO.2010.31.4310. Epub 2010 Dec 20., PMID: 21172891

Gamis AS, Alonzo TA, Meshinchi S, Sung L, Gerbing RB, Raimondi SC, Hirsch BA, Kahwash SB, Heerema-McKenney A, Winter L, Glick K, Davies SM, Byron P, Smith FO, Aplenc R. Gemtuzumab ozogamicin in children and adolescents with de novo acute myeloid leukemia improves event-free survival by reducing relapse risk: results from the randomized phase III Children’s Oncology Group trial AAML0531. J Clin Oncol. 2014 Sep 20;32(27):3021-32. doi: 10.1200/JCO.2014.55.3628., PMID: 25092781

Regimen details sometimes vary slightly from the published literature after recommendation by expert committee consensus.

* The medicines, doses, combinations, and schedule in this treatment regimen have been carefully reviewed against international best practice guidelines by specialists in medical oncology around New Zealand and this advice has been accepted for publication by Te Aho o Te Kahu (the Cancer Control Agency). Sometimes medicines that are used in routine clinical practice have not been through a formal review process by the NZ Medicines Regulator Medsafe and are therefore considered unapproved or off-label. These medicines are legally able to be prescribed through sections 25 and 29 of the Medicines Act and by obtaining informed consent from patients. All treatment regimens listed on this website have been through robust peer review and are considered an accepted standard of care, whether prescribed through sections 25 or 29 or carrying formal Medsafe Approval.

s29: This symbol indicates that some formulations of the associated medicine are legally only able to be prescribed under section 29 of the Medicines Act. You can see which formulations are section 29 by hovering over the s29 symbol. You can access full medication details from the New Zealand Formulary by clicking on the medication name. Each clinician retains full responsibility for ensuring they have complied with all relevant obligations and requirements of section 29 including obtaining informed patient consent prior to prescribing the applicable medicine.