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Systemic Anti-Cancer Therapy Regimen Library

LEU ALL precursor B-cell - AALL1131 [very high risk]

Treatment Overview

This is an intensive regimen intended patients 30 years of age and under.


AALL1131 [very high risk] consists of:

  1. Induction, use regimen below specific for CNS status of patient:
  2. CNS1+, or
  3. CNS2+, or
  4. CNS3+
  5. Consolidation, use regimen below specific for CNS status of patient:
  6. CNS1/2+, or
  7. CNS3+
  8. Interim maintenance 1
  9. Delayed intensification
  10. Interim maintenance 2
  11. Maintenance (not used for transplant patients), use regimen below specific for CNS status of patient:
  12. CNS1/2+, or
  13. CNS3+

Total treatment time for all patients is 2 years from the start of Interim maintenance 1.


Each Cycle/phase starts after recovery from the previous Cycle/phase with:

  • Neutrophils greater than 0.75 x 109/L and
  • Platelets greater than 75 x 109/L.
AALL1131 [very high risk] - Induction for CNS 1+

Use Induction regimen specific for CNS status of patient. Intrathecal therapy in this Induction regimen is intended for patients with CNS1+ disease.

AALL1131 [very high risk] - Induction for CNS 2+

Use Induction regimen specific for CNS status of patient. Intrathecal therapy in this Induction regimen is intended for patients with CNS2+ disease.

AALL1131 [very high risk] - Induction for CNS 3+

Use Induction regimen specific for CNS status of patient. Intrathecal therapy in this Induction regimen is intended for patients with CNS3+ disease.

AALL1131 [very high risk] - Consolidation for CNS 1/2+

Use Consolidation regimen specific for CNS status of patient. Intrathecal therapy in this Consolidation 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.

AALL1131 [very high risk] - Consolidation for CNS 3+

Use Consolidation regimen specific for CNS status of patient. Intrathecal therapy in this Consolidation regimen intended for patients with CNS3+ 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.

AALL1131 [very high risk] - Interim maintenance 1

Starts on day 57 of Consolidation or count recovery, whichever occurs later. 

Prior to each dose of high dose metHOTREXATe neutrophils should be greater than 0.75 x 109/L and platelets greater than 75 x 109/L.

AALL1131 [very high risk] - Delayed intensification

Starts after count recovery from Interim maintenance 1.

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

AALL1131 [very high risk] - Interim maintenance 2

Starts after count recovery from Delayed intensification.

AALL1131 [very high risk] - Maintenance for CNS 1/2+

Use Maintenance regimen specific for CNS status of patient. Intrathecal therapy in this Maintenance regimen is intended for patients with CNS1+ or 2+ disease, for those who did not receive CNS radiation.

Maintenance is not to be used for any transplant patients.

Starts on day 57 of Interim maintenance 2 or on count recovery, whichever occurs later.

Total treatment time for all patients is 2 years from start of Interim maintenance 1.

AALL1131 [very high risk] - Maintenance for CNS 3+

Use Maintenance regimen specific for CNS status of patient. Intrathecal therapy in this Maintenance regimen is intended for patients with CNS3+ disease. Commence cranial irradiation for CNS3 patients as per institutional practice.

Maintenance is not to be used for any transplant patients.

Starts on day 57 of Interim maintenance 2 or on count recovery, whichever occurs later.

Total treatment time for all patients is 2 years from start of Interim maintenance 1.

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Variable
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: Variable
Gastroprotection: Variable
Hydration: Variable
Hypersensitivity / Infusion related reaction risk: Variable
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended
Tumour lysis syndrome prophylaxis: Variable

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.

References

Salzer WL, Burke MJ, Devidas M, Chen S, Gore L, Larsen EC, Borowitz M, Wood B, Heerema NA, Carroll AJ, Hilden JM, Loh ML, Raetz EA, Winick NJ, Carroll WL, Hunger SP. Toxicity associated with intensive postinduction therapy incorporating clofarabine in the very high-risk stratum of patients with newly diagnosed high-risk B-lymphoblastic leukemia: A report from the Children's Oncology Group study AALL1131. Cancer. 2018 Mar 15;124(6):1150-1159. doi: 10.1002/cncr.31099. Epub 2017 Dec 19. Erratum in: Cancer. 2021 Nov 1;127(21):4106-4107., PMID: 29266189

Servier Laboratories NZ Ltd Oncaspar®New Zealand data sheet 25 August 2022 https://www.medsafe.govt.nz/profs/datasheet/o/oncasparinj.pdf (accessed 7 February 2023).

Amendment to AALL1131 from AALL1732 – Maintenance: Vincristine and prednisone frequency reduced to once every 84 days https://clinicaltrials.gov/ct2/show/NCT03959085 (accessed 24 November 2022).

Regimen details sometimes vary slightly from the published literature after recommendation by expert committee consensus.

* 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.