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Home > LEU ALL precursor B-cell - AALL1131 [very high risk] > LEU - AALL1131 Consolidation [CNS1 and 2]
This regimen is a component of LEU ALL precursor B-cell - AALL1131 [very high risk]

AALL1131 [very high risk] - Consolidation for CNS 1/2+ (LEU ALL precursor B-cell - AALL1131 [very high risk])

Treatment Overview

Use Consolidation regimen specific for CNS status of patient. Intrathecal therapy in this regimen intended for patients with CNS1+ or 2+ disease.


Starts on day 36 of Induction or on count recovery, whichever occurs later. 

Day 29 of this cycle should be delayed if necessary until count recovery.

Count recovery is defined as:

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

Cycle 1 - 56 days

Cycle length:
56

Day 29 should be delayed if necessary until count recovery, with neutrophils greater than 0.75 x 109/L and platelets greater than 75 x 109/L.


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


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


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


pegaspargase:

  • Reduce dose for patients 22 years of age or over and cap dose for obesity, see Additional details.
  • 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 details

Cycle 1 - 56 days

Medication Dose Route Days Max Duration
CYCLOPHOSPHamide 1000 mg/m² intravenous 1, 29 60 minutes
cytarabine 75 mg/m² Once daily subcutaneous injection 1 to 4,
8 to 11,
29 to 32,
36 to 39
mercaptOPURine 60 mg/m² Once daily oral administration 1 to 14,
29 to 42
metHOTREXATe * 15 mg intrathecal injection 1, 8, 15,
22
vinCRISTine * 1.5 mg/m² Cap dose per administration at: 2 mg intravenous 15, 22, 43,
50		 10 minutes
paracetamol * 1000 mg flat dosing oral administration 15, 43
loratadine * 10 mg oral administration 15, 43
famotidine * 20 mg oral administration 15, 43
pegaspargase * 2500 international unit/m² intravenous 15, 43 120 minutes

Day 29 should be delayed if necessary until count recovery, with neutrophils greater than 0.75 x 109/L and platelets greater than 75 x 109/L.


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


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


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


pegaspargase:

  • Reduce dose for patients 22 years of age or over and cap dose for obesity, see Additional details.
  • 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.

Full details

Cycle 1 - 56 days

Day: 1

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.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously 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.
metHOTREXATe * 15 mg intrathecal injection
Instructions:
  • 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.
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: 3

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

Or administer intravenously 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.

Day: 4

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

Or administer intravenously 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.

Day: 5

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: 6

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: 7

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: 8

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

Or administer intravenously 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.
metHOTREXATe * 15 mg intrathecal injection
Instructions:
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Day: 9

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

Or administer intravenously 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.

Day: 10

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

Or administer intravenously 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.

Day: 11

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

Or administer intravenously 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.

Day: 12

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: 13

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: 14

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: 15

Medication Dose Route Max duration Details
metHOTREXATe * 15 mg intrathecal injection
Instructions:
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.
vinCRISTine * 1.5 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.
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 * 2500 international unit/m² intravenous 120 minutes
Instructions:
  • Reduce dose if ≥ 22 years of age and cap dose for obesity, see Additional details.
  • 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: 22

Medication Dose Route Max duration Details
metHOTREXATe * 15 mg intrathecal injection
Instructions:
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.
vinCRISTine * 1.5 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.

Day: 29

Medication Dose Route Max duration Details
CYCLOPHOSPHamide 1000 mg/m² intravenous 60 minutes
Instructions:
  • Delay Day 29 if necessary until count recovery, with neutrophils > 0.75 x 109/L and platelets > 75 x 109/L.
  • 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.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:
  • Or administer intravenously as per institutional practice.
  • Delay Day 29 if necessary until count recovery, with neutrophils > 0.75 x 109/L and platelets > 75 x 109/L.
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Delay Day 29 if necessary until count recovery, with neutrophils > 0.75 x 109/L and platelets > 75 x 109/L.
  • 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: 30

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

Or administer intravenously 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.

Day: 31

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

Or administer intravenously 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.

Day: 32

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

Or administer intravenously 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.

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
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: 36

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

Or administer intravenously 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.

Day: 37

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

Or administer intravenously 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.

Day: 38

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

Or administer intravenously 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.

Day: 39

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

Or administer intravenously 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.

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
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: 43

Medication Dose Route Max duration Details
vinCRISTine * 1.5 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.
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 * 2500 international unit/m² intravenous 120 minutes
Instructions:
  • Reduce dose if ≥ 22 years of age and cap dose for obesity, see Additional details.
  • 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: 50

Medication Dose Route Max duration Details
vinCRISTine * 1.5 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.

Additional details

Section 1: Age and weight dose adjustments for pegaspargase

Patients 22 years of age and over: Reduce dose of pegaspargase to 2000 international units/m2 .

Cap pegaspargase dose at 3750 international units flat dose for obesity, defined as:

  • BMI 95% or greater for patients less than 20 years of age, or
  • BMI 30 or greater for patients 20 years of age and over. 

Section 2: Further information on pegaspargase

  • Pegaspargase (and asparaginase products) should only be administered by centres with appropriate expertise. 
  • There is limited data available for use of pegaspargase in patients 65 years and older. Strongly consider not using pegaspargase in patients 65 years and older.
  • 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
Hypersensitivity / Infusion related reaction risk: High - routine premedication 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 days 1 and 29;
  • MINIMAL to LOW days 2 to 14 and 30 to 42;
  • MINIMAL days 15, 22, 43 and 50.

References

No references

* 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.