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Systemic Anti-Cancer Therapy Regimen Library

Home > LEU AML Relapsed - FLAG [fludarabine, cytarabine and filgrastim] [under 60 years]

LEU AML Relapsed - FLAG [fludarabine, cytarabine and filgrastim] [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

Give filgrastim 5 microgram/kg subcutaneously ONCE daily from days 1 to 6 and continue daily administration until neutrophil recovery past nadir.

Cycle details

Cycles 1 to 2 - 28 days

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

Give filgrastim 5 microgram/kg subcutaneously ONCE daily from days 1 to 6 and continue daily administration until neutrophil recovery past nadir.

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.
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.
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:

Continue daily administration until neutrophil recovery past the nadir.

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: 7

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.

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

Montillo M, Mirto S, Petti MC, Latagliata R, Magrin S, Pinto A, Zagonel V, Mele G, Tedeschi A, Ferrara F. Fludarabine, cytarabine, and G-CSF (FLAG) for the treatment of poor risk acute myeloid leukemia. Am J Hematol. 1998 Jun;58(2):105-9. doi: 10.1002/(sici)1096-8652(199806)58:2<105::aid-ajh3>3.0.co;2-w., PMID: 9625576

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

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).

* 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.