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Systemic Anti-Cancer Therapy Regimen Library

LEU AML - FLAG-Ida [fludarabine, cytarabine, filgrastim and IDArubicin] [under 60 years]

Treatment Overview

Frequency: Every 28 days or on count recovery.

Number of cycles: 1 or 2.


This regimen contains a medicine where one or more biosimilars may exist. Any biosimilars used have been reviewed by the regulator (Medsafe) and relevant specialists were consulted nationally. Where regulators, in consultation with relevant specialists, have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably.

Cycles 1 to 2 - 28 days

Cycle length:
28

Cycle details

Cycles 1 to 2 - 28 days

Medication Dose Route Days Max Duration
filgrastim * 5 microgram/kg Once daily subcutaneous injection 1 to 7
fludarabine * 30 mg/m² Once daily intravenous 2 to 6 30 minutes
cytarabine 2000 mg/m² Once daily intravenous 2 to 6 4 hours
IDArubicin * 8 mg/m² Once daily intravenous 4, 5, 6 15 minutes
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye 2 to 8

Full details

Cycles 1 to 2 - 28 days

Day: 1

Medication Dose Route Max duration Details
filgrastim * 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 2

Medication Dose Route Max duration Details
filgrastim * 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

fludarabine * 30 mg/m² Once daily intravenous 30 minutes
cytarabine 2000 mg/m² Once daily intravenous 4 hours
Instructions:

Commence 4 hours after the fludarabine infusion.

prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 8.

Day: 3

Medication Dose Route Max duration Details
filgrastim * 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

fludarabine * 30 mg/m² Once daily intravenous 30 minutes
cytarabine 2000 mg/m² Once daily intravenous 4 hours
Instructions:

Commence 4 hours after the fludarabine infusion.

prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 8.

Day: 4

Medication Dose Route Max duration Details
filgrastim * 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

fludarabine * 30 mg/m² Once daily intravenous 30 minutes
cytarabine 2000 mg/m² Once daily intravenous 4 hours
Instructions:

Commence 4 hours after the fludarabine infusion.

IDArubicin * 8 mg/m² Once daily intravenous 15 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.

prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 8.

Day: 5

Medication Dose Route Max duration Details
filgrastim * 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

fludarabine * 30 mg/m² Once daily intravenous 30 minutes
cytarabine 2000 mg/m² Once daily intravenous 4 hours
Instructions:

Commence 4 hours after the fludarabine infusion.

IDArubicin * 8 mg/m² Once daily intravenous 15 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.

prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 8.

Day: 6

Medication Dose Route Max duration Details
filgrastim * 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

fludarabine * 30 mg/m² Once daily intravenous 30 minutes
cytarabine 2000 mg/m² Once daily intravenous 4 hours
Instructions:

Commence 4 hours after the fludarabine infusion.

IDArubicin * 8 mg/m² Once daily intravenous 15 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.

prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 8.

Day: 7

Medication Dose Route Max duration Details
filgrastim * 5 microgram/kg Once daily subcutaneous injection
Instructions:

Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 8.

Day: 8

Medication Dose Route Max duration Details
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye
Instructions:

Instil ONE drop into each eye every FOUR hours on days 2 to 8.

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Routine antifungal prophylaxis recommended
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Emetogenicity: Medium
Irradiated blood components: Irradiation of blood components is recommended
Ocular toxicity risk: High - administer corticosteroid eyedrops to minimise corneal toxicity
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended
Tumour lysis syndrome prophylaxis: Variable

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. 

PJP prophylaxis with co-trimoxazole: Consider starting after count recovery.

Tumour lysis syndrome prophylaxis: Recommended for first cycle of treatment and only for further cycles if not in complete remission.

References

Burnett AK, Hills RK, Nielsen OJ, Freeman S, Ali A, Cahalin P, Hunter A, Thomas IF, Russell NH. A comparison of FLAG-Ida and daunorubicin combined with clofarabine in high-risk acute myeloid leukaemia: data from the UK NCRI AML17 Trial. Leukemia. 2018 Dec;32(12):2693-2697. doi: 10.1038/s41375-018-0148-3. Epub 2018 Jun 6., PMID: 29875430

Burnett AK, Russell NH, Hills RK, Hunter AE, Kjeldsen L, Yin J, Gibson BE, Wheatley K, Milligan D. Optimization of chemotherapy for younger patients with acute myeloid leukemia: results of the medical research council AML15 trial. J Clin Oncol. 2013 Sep 20;31(27):3360-8. doi: 10.1200/JCO.2012.47.4874. Epub 2013 Aug 12., PMID: 23940227

Russell NH, Hills RK, Kjeldsen L, Clark RE, Ali S, Cahalin P, Thomas IF, Burnett AK. A randomised comparison of FLAG-Ida versus daunorubicin combined with clofarabine in relapsed or refractory acute myeloid leukaemia: Results from the UK NCRI AML17 trial. Br J Haematol. 2022 Apr 6. doi: 10.1111/bjh.18195. Epub ahead of print., PMID: 35388465

Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142., PMID: 28848668

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14., PMID: 29443651

AML17 trial protocol Version 10.2 dated June 2019.

New Zealand Blood Service Transfusion Medicine Handbook Third Edition, 2016 https://www.nzblood.co.nz/assets/Transfusion-Medicine/PDFs/111G122.pdf (accessed 13/7/2022).

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.