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Home > LEU ALL precursor B-cell - UKALL14 with RITUximab [40 years and under] [not for transplant] > LEU - UKALL14 with RITUximab [40 years and under] Consolidation [Cycle 1 and 2]
This regimen is a component of LEU ALL precursor B-cell - UKALL14 with RITUximab [40 years and under] [not for transplant]

UKALL14 with RITUximab [40 years and under] [not for transplant] - Consolidation [Cycles 1 and 2] (LEU ALL precursor B-cell - UKALL14 with RITUximab [40 years and under] [not for transplant])

Treatment Overview

Consolidation Cycle 1 starts after count recovery from Intensification/CNS prophylaxis.

Cycle 2 is given on count recovery from Cycle 1.

Count recovery is defined as:

  • Neutrophils greater than 0.75 x 109/L, and
  • Platelets greater than 75 x 109/L.

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 - 21 days

Cycle length:
21

RITUximab: Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.


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


Intrathecal metHOTREXATe:

  • Day of administration can be moved +/- 3 days.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

pegaspargase:

  • DO NOT use in BCR-ABL1+ patients.
  • Consideration can be given to reducing dose of pegaspargase to 500 international units/m2 for certain patients.
  • 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.

Cycle 2 - 21 days

Cycle length:
21

RITUximab: Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.


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


Intrathecal metHOTREXATe:

  • Day of administration can be moved +/- 3 days.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Cycle details

Cycle 1 - 21 days

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1
loratadine * 10 mg oral administration 1
RITUximab * 375 mg/m² intravenous 1 6 hours
cytarabine 75 mg/m² Once daily subcutaneous injection 1 to 5
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 1 to 5 60 minutes
metHOTREXATe 12 mg flat dosing intrathecal injection 1
paracetamol * 1000 mg flat dosing oral administration 5
loratadine * 10 mg oral administration 5
famotidine * 20 mg oral administration 5
pegaspargase * 1000 international unit/m² intravenous 5 120 minutes

RITUximab: Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.


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


Intrathecal metHOTREXATe:

  • Day of administration can be moved +/- 3 days.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

pegaspargase:

  • DO NOT use in BCR-ABL1+ patients.
  • Consideration can be given to reducing dose of pegaspargase to 500 international units/m2 for certain patients.
  • 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.

Cycle 2 - 21 days

Medication Dose Route Days Max Duration
paracetamol * 1000 mg flat dosing oral administration 1
loratadine * 10 mg oral administration 1
RITUximab * 375 mg/m² intravenous 1 6 hours
cytarabine 75 mg/m² Once daily subcutaneous injection 1 to 5
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 1 to 5 60 minutes
metHOTREXATe 12 mg flat dosing intrathecal injection 1

RITUximab: Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.


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


Intrathecal metHOTREXATe:

  • Day of administration can be moved +/- 3 days.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Full details

Cycle 1 - 21 days

Day: 1

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

30 to 60 minutes prior to RITUximab.
loratadine * 10 mg oral administration
Instructions:

30 to 60 minutes prior to RITUximab.
RITUximab * 375 mg/m² intravenous 6 hours
Instructions:
  • Consider administering corticosteroid premedication before RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.
  • Start infusion at 100 mg/hour. If tolerated, rate can be increased by 100 mg/hour every 30 minutes to a maximum rate of 400 mg/hour, or as per institutional practice.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 60 minutes
metHOTREXATe 12 mg flat dosing intrathecal injection
Instructions:
  • Day of administration can be moved +/- 3 days.
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Day: 2

Medication Dose Route Max duration Details
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 60 minutes

Day: 3

Medication Dose Route Max duration Details
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 60 minutes

Day: 4

Medication Dose Route Max duration Details
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 60 minutes

Day: 5

Medication Dose Route Max duration Details
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 60 minutes
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.
pegaspargase * 1000 international unit/m² intravenous 120 minutes
Instructions:
  • DO NOT use in BCR-ABL1+ patients.
  • Consider dose reduction to 500 international units/m2 for certain patients.
  • 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:

Cycle 2 - 21 days

Day: 1

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

30 to 60 minutes prior to RITUximab.
loratadine * 10 mg oral administration
Instructions:

30 to 60 minutes prior to RITUximab.
RITUximab * 375 mg/m² intravenous 6 hours
Instructions:
  • Consider administering corticosteroid premedication before RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.
  • Start infusion at 100 mg/hour. If tolerated, rate can be increased by 100 mg/hour every 30 minutes to a maximum rate of 400 mg/hour, or as per institutional practice.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 60 minutes
metHOTREXATe 12 mg flat dosing intrathecal injection
Instructions:
  • Day of administration can be moved +/- 3 days.
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Day: 2

Medication Dose Route Max duration Details
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 60 minutes

Day: 3

Medication Dose Route Max duration Details
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 60 minutes

Day: 4

Medication Dose Route Max duration Details
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 60 minutes

Day: 5

Medication Dose Route Max duration Details
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
etoposide (as phosphate) * 100 mg/m² Once daily intravenous 60 minutes

Additional details

Section 1: Further information of 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 hepatitis B virus: Required for anti–HBc positive patients at risk of reactivation
Antiviral prophylaxis for herpes virus: Routine antiviral prophylaxis recommended
Emetogenicity: Low
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended

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.