Systemic Anti-Cancer Therapy Regimen Library
LEU ALL precursor B-cell BCR-ABL1+ - modified AALL1131 with daSATinib
Treatment Overview
This is an intensive regimen intended for patients 30 years of age and under, with BCR-ABL1 postitive disease.
Note: The addition of daSATinib to the AALL1131 backbone can result in significant toxicity. Imatinib is preferred in the young adult population, see LEU ALL precursor B-cell BCR-ABL1+ - modified AALL1131 with imatinib. Careful patient selection is therefore necessary when using daSATinib.
AALL1131 (modified) with daSATinib [BCR-ABL1+] consists of:
- Induction, use regimen below specific for CNS status of patient:
- CNS1+, or
- CNS2+, or
- CNS3+
- Consolidation, use regimen below specific for CNS status of patient:
- CNS1/2+, or
- CNS3+
- Interim maintenance 1
- Delayed intensification
- Interim maintenance 2
- Maintenance (not used for transplant patients), use regimen below specific for CNS status of patient:
- CNS1/2+, or
- CNS3+
Total treatment time for all patients is 2 years from the start of Interim maintenance 1; daSATinib is taken indefinitely.
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.
daSATinib is taken continuously starting from Day 15 of Induction, the dose included in regimen may be tailored to individual patient response and tolerability.
Use Induction regimen specific for CNS status of patient. Intrathecal therapy in this Induction regimen is intended for patients with CNS 1+ disease.
Use Induction regimen specific for CNS status of patient. Intrathecal therapy in this Induction regimen is intended for patients with CNS2+ disease.
Use Induction regimen specific for CNS status of patient. Intrathecal therapy in this Induction regimen is intended for patients with CNS3+ disease.
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.
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.
Starts on day 57 of Consolidation or on 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.
Starts after count recovery from Interim maintenance 1.
Day 29 of this cycle should be delayed, if necessary, until count recovery.
Starts on day 57 of Delayed intensification or on count recovery, whichever occurs later.
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; daSATinib is taken indefinitely.
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; daSATinib is taken indefinitely.
Supportive Care Factors
| Factor | Value |
|---|---|
| Antifungal prophylaxis: | Variable |
| Antiviral prophylaxis for herpes virus: | Routine antiviral prophylaxis recommended |
| Constipation risk: | Variable |
| Diarrhoea risk: | Variable |
| 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
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.