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Home > LEU ALL precursor T-cell - GMALL T-LBL 1/2004 [55 years and under] > LEU - GMALL T-LBL 1/2004 Pre-phase and Induction [55 years and under]
This regimen is a component of LEU ALL precursor T-cell - GMALL T-LBL 1/2004 [55 years and under]

GMALL T-LBL 1/2004 [55 years and under] - Pre-phase and Induction I and II (LEU ALL precursor T-cell - GMALL T-LBL 1/2004 [55 years and under])

Treatment Overview

Pre-phase [days 1 to 5] followed immediately by Induction I [days 6 to 20] then Induction II [days 26 to 46].


All patients receive prophylactic cranial radiotherapy parallel to Induction II [days 26 to 46] – see protocol for details.

Patients with initial mediastinal tumour receive mediastinal radiotherapy as soon as possible after blood regeneration after Induction II [days 26 to 46] – see protocol for details.


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 - 46 days

Cycle length:
46

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


filgrastim: Give filgrastim 5 microgram/kg subcutaneously ONCE daily from Day 6 until neutrophil recovery past the nadir, AND from Day 26 until neutrophil recovery past the nadir.


pegaspargase:

  • If platelets are less than 50 x 109/L administer IV over 120 minutes.
  • Monitor patients for one hour after administration of pegaspargase in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g. adrenaline, oxygen, intravenous steroids, antihistamines).
  • See also Additional details for Further information on pegaspargase.

mercaptOPURine: Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.


cytarabine: Administer by subcutaneous injection (as above) or alternatively administer intravenously as per institutional practice.

Cycle details

Cycle 1 - 46 days

Medication Dose Route Days Max Duration
metHOTREXATe * 15 mg flat dosing intrathecal injection 1, 28, 35,
42
dexamethasone 3.3 mg/m² Three times daily oral administration 1 to 7,
13 to 16
CYCLOPHOSPHamide 200 mg/m² Once daily intravenous 3, 4, 5 60 minutes
vinCRISTine 2 mg flat dosing intravenous 6, 13, 20 10 minutes
DAUNOrubicin * 45 mg/m² intravenous 6, 7, 13,
14		 15 minutes
filgrastim 5 microgram/kg Once daily subcutaneous injection 6
paracetamol * 1000 mg flat dosing oral administration 20
loratadine * 10 mg oral administration 20
famotidine * 20 mg oral administration 20
pegaspargase * 1000 international unit/m² intramuscular injection 20
CYCLOPHOSPHamide 1000 mg/m² intravenous 26, 46 60 minutes
mercaptOPURine 60 mg/m² Once daily oral administration 26 to 46
filgrastim 5 microgram/kg Once daily subcutaneous injection 26
cytarabine 75 mg/m² Once daily subcutaneous injection 28 to 31,
35 to 38,
42 to 45

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


filgrastim: Give filgrastim 5 microgram/kg subcutaneously ONCE daily from Day 6 until neutrophil recovery past the nadir, AND from Day 26 until neutrophil recovery past the nadir.


pegaspargase:

  • If platelets are less than 50 x 109/L administer IV over 120 minutes.
  • Monitor patients for one hour after administration of pegaspargase in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g. adrenaline, oxygen, intravenous steroids, antihistamines).
  • See also Additional details for Further information on pegaspargase.

mercaptOPURine: Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.


cytarabine: Administer by subcutaneous injection (as above) or alternatively administer intravenously as per institutional practice.

Full details

Cycle 1 - 46 days

Day: 1

Medication Dose Route Max duration Details
metHOTREXATe * 15 mg flat dosing intrathecal injection
Instructions:
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.
dexamethasone 3.3 mg/m² Three times daily oral administration
Instructions:

Take with food.

Day: 2

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

Take with food.

Day: 3

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

Take with food.
CYCLOPHOSPHamide 200 mg/m² Once daily intravenous 60 minutes

Day: 4

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

Take with food.
CYCLOPHOSPHamide 200 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.
CYCLOPHOSPHamide 200 mg/m² Once daily intravenous 60 minutes

Day: 6

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

Take with food.
vinCRISTine 2 mg flat dosing 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.
DAUNOrubicin * 45 mg/m² 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.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:
  • Give ONCE daily from Day 6 until neutrophil recovery past the nadir.
  • Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Day: 7

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

Take with food.
DAUNOrubicin * 45 mg/m² 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.

Day: 13

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

Take with food.
vinCRISTine 2 mg flat dosing 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.
DAUNOrubicin * 45 mg/m² 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.

Day: 14

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

Take with food.
DAUNOrubicin * 45 mg/m² 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.

Day: 15

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

Take with food.

Day: 16

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

Take with food.

Day: 20

Medication Dose Route Max duration Details
vinCRISTine 2 mg flat dosing 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.
paracetamol * 1000 mg flat dosing oral administration
Instructions:

30 minutes prior to pegaspargase.
loratadine * 10 mg oral administration
Instructions:

30 minutes prior to pegaspargase.
famotidine * 20 mg oral administration
Instructions:

30 minutes prior to pegaspargase.

  • Do not take indigestion remedies, iron or calcium preparations within 2 hours of taking this medicine.
pegaspargase * 1000 international unit/m² intramuscular injection
Instructions:
  • If platelets < 50 x 109/L administer IV over 120 minutes.
  • Monitor patients for one hour after administration of pegaspargase in a setting with resuscitation equipment and other agents necessary to treat anaphylaxis (e.g. adrenaline, oxygen, intravenous steroids, antihistamines).
Additional details:

Day: 26

Medication Dose Route Max duration Details
CYCLOPHOSPHamide 1000 mg/m² intravenous 60 minutes
Instructions:

Consider hydration with at least 2000 to 3000 ml over 24 hours as oral or IV fluid on day(s) of CYCLOPHOSPHamide and for 24 hours after or as per institutional practice.
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Give ONCE daily from Day 26 until neutrophil recovery past the nadir.

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

Day: 27

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 28

Medication Dose Route Max duration Details
metHOTREXATe * 15 mg flat dosing intrathecal injection
Instructions:
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 29

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 30

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 31

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 32

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 33

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 34

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 35

Medication Dose Route Max duration Details
metHOTREXATe * 15 mg flat dosing intrathecal injection
Instructions:
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 36

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 37

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 38

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 39

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 40

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 41

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 42

Medication Dose Route Max duration Details
metHOTREXATe * 15 mg flat dosing intrathecal injection
Instructions:
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 43

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 44

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 45

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 46

Medication Dose Route Max duration Details
CYCLOPHOSPHamide 1000 mg/m² intravenous 60 minutes
Instructions:

Consider hydration with at least 2000 to 3000 ml over 24 hours as oral or IV fluid on day(s) of CYCLOPHOSPHamide and for 24 hours after or as per institutional practice.
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Additional details

Section 1: Further information for pegaspargase

  • Pegaspargase (and asparaginase products) should only be administered by centres with appropriate expertise. 
  • Consideration can be given to reducing dose of pegaspargase to 500 international units/m2 for certain patients. 
  • Prior to using pegaspargase perform a baseline abdominal ultrasound scan is recommended to examine the biliary tract, pancreas and hepatic echotexture. Pegasparagase is contraindicated in those with a history of severe significant hepatic impairment, including alcoholic liver disease, autoimmune or viral hepatitis, and steatohepatitis/NASH.
  • If after pegaspargase there is any evidence of steatosis/liver disease, perform an ultrasound of the liver. 
  • Development of anti-asparaginase antibodies may be associated with low asparaginase activity levels. As a precaution, periodic measurement of the asparaginase activity level in serum or plasma is recommended. 
  • Routine monitoring for bone marrow suppression, coagulations abnormalities, pancreatitis, hepatic toxicity, hyperuricaemia, hyperglycaemia, ketoacidosis and hypertriglyceridaemia is required. See Additional information - pegaspargase.
  • To reduce risk of hypersensitivity to pegaspargase avoid using other pegylated products e.g. pegFILGRASTIM if there is a suitable non-pegylated form.

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
Gastroprotection: Gastroprotection is recommended
Growth factor support: Recommended for primary prophylaxis
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis is 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 days 3 to 7, days 13, 14, 26 and 46.
  • MINIMAL day 20;
  • MINIMAL to LOW days 27 to 45.

Gastroprotection: Gastroprotection agents are only intended for short term use while patient is receiving corticosteroid treatment doses.

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.