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Home > LEU ALL precursor T-cell - GMALL T-LBL 1/2004 [over 55 years] > LEU - GMALL T-LBL 1/2004 Consolidation I [over 55 years]
This regimen is a component of LEU ALL precursor T-cell - GMALL T-LBL 1/2004 [over 55 years]

GMALL T-LBL 1/2004 [over 55 years] - Consolidation I (LEU ALL precursor T-cell - GMALL T-LBL 1/2004 [over 55 years])

Treatment Overview

Commencing week 11.


High dose metHOTREXATe

  • metHOTREXATe levels MUST be measured once every 24 hours.
  • Intravenous alkalinized fluids MUST be commenced at least 6 hours before the start of metHOTREXATe infusion and MUST continue until the metHOTREXATe serum level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice). Additional oral alkalinization can be considered as Ural® 2 sachets orally the night before and 2 sachets the morning of high dose metHOTREXATe infusion.
  • Before commencing the high dose metHOTREXATe infusion, urinary pH MUST be 7.5 or above (pH 7.5 to 8.0).
  • Closely monitor renal function, electrolytes, fluid balance, and weight.
  • foliNIc acid MUST start 36 hours after start of metHOTREXATe infusion and MUST continue to be administered until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).

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.

Cycle 1 - 35 days

Cycle length:
35

foliNIc acid: MUST start 36 hours after start of metHOTREXATe infusion and MUST continue to be administered until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).


cytarabine: If renal function reduced from baseline following high dose metHOTREXATe, dose should be reviewed by the haematologist.


filgrastim: Give filgrastim 5 microgram/kg subcutaneously ONCE daily from Day 7 until neutrophil recovery past the nadir.


Intrathecal metHOTREXATe: For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Cycle details

Cycle 1 - 35 days

Medication Dose Route Days Max Duration
dexamethasone 3.3 mg/m² Three times daily oral administration 1 to 5
vinCRISTine 1.4 mg/m² Cap dose per administration at: 2 mg intravenous 1 10 minutes
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous 1 to 4
sodium bicarbonate 50 mmol intravenous 1 to 4
acetazolamide * 250 mg Four times daily oral administration 1 to 4
metHOTREXATe 1000 mg/m² intravenous 1 24 hours Min: 24 hours
foliNIc acid (as calcium folinate) 15 mg/m² Every three hours intravenous 2, 3 2 minutes
foliNIc acid (as calcium folinate) 15 mg/m² Every six hours intravenous 3, 4 2 minutes
etoposide (as phosphate) * 250 mg/m² Once daily intravenous 4, 5 60 minutes
cytarabine 1000 mg/m² Twice daily intravenous 5 3 hours
prednisolone acetate 1% (10 mg/mL) eye drops * 1 Drop Every four hours application to the eye 5, 6, 7
filgrastim 5 microgram/kg Once daily subcutaneous injection 7
metHOTREXATe 12 mg flat dosing intrathecal injection 12
cytarabine 30 mg flat dosing intrathecal injection 12
hydrocortisone * 30 mg flat dosing intrathecal injection 12

foliNIc acid: MUST start 36 hours after start of metHOTREXATe infusion and MUST continue to be administered until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).


cytarabine: If renal function reduced from baseline following high dose metHOTREXATe, dose should be reviewed by the haematologist.


filgrastim: Give filgrastim 5 microgram/kg subcutaneously ONCE daily from Day 7 until neutrophil recovery past the nadir.


Intrathecal metHOTREXATe: For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Full details

Cycle 1 - 35 days

Day: 1

Medication Dose Route Max duration Details
dexamethasone 3.3 mg/m² Three times daily oral administration
Instructions:

Take with food.
vinCRISTine 1.4 mg/m² Cap dose per administration at: 2 mg intravenous 10 minutes
Instructions:
  • Diluted in a minibag.
  • FOR INTRAVENOUS USE ONLY – fatal if given by any other routes.
  • Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate.
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Commence at least 6 hours prior to metHOTREXATe infusion and run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
metHOTREXATe 1000 mg/m² intravenous 24 hours Min: 24 hours
Instructions:

Continuous infusion over 24 hours.

Day: 2

Medication Dose Route Max duration Details
dexamethasone 3.3 mg/m² Three times daily oral administration
Instructions:

Take with food.
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate.
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
foliNIc acid (as calcium folinate) 15 mg/m² Every three hours intravenous 2 minutes
Instructions:
  • Starting 36 hours after start of metHOTREXATe infusion and continue to administer every 3 hours for the first 5 doses, then every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • If metHOTREXATe elimination is impaired the dose of foliNIc acid will need to be increased. Consult prescribing information.

Day: 3

Medication Dose Route Max duration Details
dexamethasone 3.3 mg/m² Three times daily oral administration
Instructions:

Take with food.
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate.
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
foliNIc acid (as calcium folinate) 15 mg/m² Every three hours intravenous 2 minutes
Instructions:
  • Administer every 3 hours for the first 5 doses, then every 6 hours (see below) until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • If metHOTREXATe elimination is impaired the dose of foliNIc acid will need to be increased. Consult prescribing information.
foliNIc acid (as calcium folinate) 15 mg/m² Every six hours intravenous 2 minutes
Instructions:
  • After 5 doses at 3 hourly intervals (see above) continue to administer every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • If metHOTREXATe elimination is impaired the dose of foliNIc acid will need to be increased. Consult prescribing information.

Day: 4

Medication Dose Route Max duration Details
dexamethasone 3.3 mg/m² Three times daily oral administration
Instructions:

Take with food.
potassium chloride 20mmol/1000mL + sodium chloride 0.18% + glucose 4% 125 mL/m²/hour intravenous
Instructions:
  • To each 1000 mL bag admix 50 mmol sodium bicarbonate.
  • Or an alternative alkalinized intravenous infusion may be used as per institutional practice.
  • Run continuously until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
sodium bicarbonate 50 mmol intravenous
Instructions:
  • Admix 50 mmol sodium bicarbonate to each 1000 mL bag of potassium chloride 20 mmol + sodium chloride 0.18% + glucose 4%.
  • Dose of sodium bicarbonate is approximately 6 mmol/m2/hour when admixed bag is infused at 125 mL/m2/hour.
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
acetazolamide * 250 mg Four times daily oral administration
Instructions:

When required.

  • Administer immediately if urinary pH drops below 7.5 during metHOTREXATe infusion and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
foliNIc acid (as calcium folinate) 15 mg/m² Every six hours intravenous 2 minutes
Instructions:
  • Continue to administer every 6 hours until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1 µmol/L (level as per institutional practice).
  • If metHOTREXATe elimination is impaired the dose of foliNIc acid will need to be increased. Consult prescribing information.
  • Administration may continue past Day 4 if metHOTREXATe level is still elevated.
etoposide (as phosphate) * 250 mg/m² Once daily intravenous 60 minutes

Day: 5

Medication Dose Route Max duration Details
dexamethasone 3.3 mg/m² Three times daily oral administration
Instructions:

Take with food.
etoposide (as phosphate) * 250 mg/m² Once daily intravenous 60 minutes
cytarabine 1000 mg/m² Twice daily intravenous 3 hours
Instructions:

Every 12 hours.

If renal function reduced from baseline following high dose metHOTREXATe, dose should be reviewed by the haematologist.
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 5 to 7.

Day: 6

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 5 to 7.

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 5 to 7.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Give ONCE daily from Day 7 until neutrophil recovery past the nadir.

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

Day: 12

Medication Dose Route Max duration Details
metHOTREXATe 12 mg flat dosing intrathecal injection
Instructions:
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.
cytarabine 30 mg flat dosing intrathecal injection
Instructions:

Adhere to local institution policy for intrathecal administration.
hydrocortisone * 30 mg flat dosing intrathecal injection
Instructions:

Adhere to local institution policy for intrathecal administration.

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Routine antifungal prophylaxis recommended
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Constipation risk: Consider prescribing laxatives with this treatment
Emetogenicity: Variable
Folinic acid rescue for high dose methotrexate: Mandatory
Gastroprotection: Gastroprotection is recommended
Growth factor support: Recommended for primary prophylaxis
Hydration: Routine hydration recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended

Antifungal prophylaxis: Inhibition of CYP3A4 by azole antifungals may lead to reduced vinCRISTine clearance and increased toxicities. Strategies to avoid this interaction may include a washout period after azole administration or using a non-azole antifungal for prophylaxis.


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 day 1, high dose metHOTREXATe may be highly emetogenic in certain patients.
  • LOW day 4.
  • MEDIUM day 5.

Gastroprotection: Use an H2 receptor antagonist as a gastroprotective agent for short term use while patient is receiving corticosteroid treatment doses. Do not use proton pump inhibitors with high dose metHOTREXATe.


PJP prophylaxis: If trimethoprim + sulfamethoxazole is used as prophylaxis, it is recommended to withhold at least 48 hours prior to high dose metHOTREXATe administration and until serum metHOTREXATe level is less than 0.05 µmol/L – 0.1µmol/L (as per institutional practice).

References

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

* 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.