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

AALL1131 [very high risk] - Interim maintenance 2 (LEU ALL precursor B-cell - AALL1131 [very high risk])

Treatment Overview

Starts on day 57 of Delayed intensification or when neutrophils are 0.75 x 109/L or greater and platelets are 75 x 109/L or greater, whichever occurs later.

Cycle 1 - 56 days

Cycle length:
56

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


Intravenous metHOTREXATe: Start at 100 mg/m2 on day 1, escalate dose once every 10 days by 50 mg/m2 only if previous dose was tolerated based on dosing criteria. See metHOTREXATe dose escalation in Additional details. 


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
metHOTREXATe * 15 mg intrathecal injection 1, 31
vinCRISTine * 1.5 mg/m² Cap dose per administration at: 2 mg intravenous 1, 11, 21,
31, 41		 10 minutes
metHOTREXATe 100 mg/m² intravenous 1 5 minutes
metHOTREXATe [Dose - see details] intravenous 11, 21, 31,
41		 5 minutes
paracetamol * 1000 mg flat dosing oral administration 2, 22
loratadine * 10 mg oral administration 2, 22
famotidine * 20 mg oral administration 2, 22
pegaspargase * 2500 international unit/m² intravenous 2, 22 120 minutes

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


Intravenous metHOTREXATe: Start at 100 mg/m2 on day 1, escalate dose once every 10 days by 50 mg/m2 only if previous dose was tolerated based on dosing criteria. See metHOTREXATe dose escalation in Additional details. 


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
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.
metHOTREXATe 100 mg/m² intravenous 5 minutes
Instructions:
  • Starting dose.
  • Maintain fluid intake.
Additional details:

Day: 2

Medication Dose Route Max duration Details
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: 11

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.
metHOTREXATe [Dose - see details] intravenous 5 minutes
Instructions:
  • Escalate dose from starting dose of 100 mg/m2 (Day 1) once every 10 days by 50 mg/m2 only if previous dose was tolerated based on dosing criteria. See mETHOTREXATe dose escalation for details. 
  • Maintain fluid intake.


Additional details:

Day: 21

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.
metHOTREXATe [Dose - see details] intravenous 5 minutes
Instructions:
  • Escalate dose from starting dose of 100 mg/m2 (Day 1) once every 10 days by 50 mg/m2 only if previous dose was tolerated based on dosing criteria. See mETHOTREXATe dose escalation for details. 
  • Maintain fluid intake.


Additional details:

Day: 22

Medication Dose Route Max duration Details
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: 31

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.
metHOTREXATe [Dose - see details] intravenous 5 minutes
Instructions:
  • Escalate dose from starting dose of 100 mg/m2 (Day 1) once every 10 days by 50 mg/m2 only if previous dose was tolerated based on dosing criteria. See mETHOTREXATe dose escalation for details. 
  • Maintain fluid intake.


Additional details:

Day: 41

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.
metHOTREXATe [Dose - see details] intravenous 5 minutes
Instructions:
  • Escalate dose from starting dose of 100 mg/m2 (Day 1) once every 10 days by 50 mg/m2 only if previous dose was tolerated based on dosing criteria. See mETHOTREXATe dose escalation for details. 
  • Maintain fluid intake.


Additional details:

Additional details

Section 1: metHOTREXATe dose escalation

Key: 

CBC = Complete Blood Count 

ANC = Absolute Neutrophil Count 

Plt = Platelets

All results x 109/L

All therapy should be interrupted for patients with presumed or proven severe infections and resumed when the signs of infection have abated. 

Section 2: Age and weight dose adjustments for pegaspargase

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

Section 3: 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:

  • LOW days 1, 11, 21, 31 and 41;
  • MINIMAL days 2 and 22.

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.