Systemic Anti-Cancer Therapy Regimen Library
LEU ALL precursor B-cell BCR-ABL1+ - UKALL14 with RITUximab and daSATinib [not for transplant]
Treatment Overview
UKALL14 with RITUximab and daSATinib [not for transplant] is intended for those with CD20 expression greater than 10%, BCR-ABL1+, without a transplant planned.
This regimen consists of:
- Steroid pre-phase
- Phase 1 Induction
- Phase 2 Induction
- Intensification/CNS prophylaxis
- Consolidation [Cycles 1 and 2]
- Consolidation/delayed intensification [Cycle 3] Day 29 of this cycle should be delayed, if necessary, until count recovery.
- Consolidation [Cycle 4]
- Maintenance
Each Cycle/phase starts after count 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, the dose included in regimen below may be increased or decreased based on individual patient response and tolerability.
dexamethasone pre-phase can be given for 5 to 7 days.
Followed by:
Starts after count recovery from Phase 1 Induction.
Starts after count recovery from Phase 2 Induction.
Consolidation Cycle 1 starts after count recovery from Intensification/CNS prophylaxis.
Cycle 2 is given on count recovery from Cycle 1.
Starts after count recovery from Consolidation Cycle 2.
Day 29 of this cycle should be delayed, if necessary, until count recovery.
Starts after count recovery from Consolidation/delayed intensification Cycle 3.
Starts after count recovery from Consolidation Cycle 4.
Supportive Care Factors
| Factor | Value |
|---|---|
| Antifungal prophylaxis: | Variable |
| 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 |
| 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 |
Antifungal prophylaxis: Inhibition of CYP3A4 by azole antifungals may lead to reduced vinCRISTine and daSATinib clearance and increased toxicities. Consider using a non-azole antifungal for prophylaxis. If an azole is used the daSATinib dose must be reduced – consult prescribing information.
Constipation/Diarrhoea risk: vinCRISTine may cause constipation and daSATinib may cause diarrhoea. Monitor gastrointestinal symptoms.
Gastroprotection:
- Gastroprotective agents such as proton pump inhibitors and H2 receptor antagonists are not recommended to be used with daSATinib because they may reduce exposure to daSATinib by increasing gastric pH. Consider using an antacid as an alternative.
- Gastroprotective agents are only intended for short term use while patient is receiving corticosteroid treatment doses.
References
Cancer Research UK and University College London, UKALL14 A randomized trial for adults with newly diagnosed acute lymphoblastic leukaemia Clinicaltrials.gov no: NCT01085617 Version 5.0 20.07.12 Accessed 16 September 2022.
Bristol-Myers Squibb (NZ) Limited Sprycel New Zealand data sheet 17 August 2022 https://www.medsafe.govt.nz/profs/datasheet/s/Spryceltab.pdf (accessed 17 October 2022).
Clinical Commissioning Policy: Addition of rituximab to first-line standard chemotherapy for CD20 positive B-cell precursor acute lymphoblastic leukaemia (Adults) Publication date: January 2021 Version number: 1.0 https://www.england.nhs.uk/wp-content/uploads/2021/01/1748-Addition-of-rituximab-to-first-line-standard-chemotherapy-for-CD20-positive-B-cell-precursor-acute-lympho.pdf (accessed 14 October 2022).
Medicines and Hepatitis B Reactivation Prescriber Update 38(1): 2-3 March 2017 https://medsafe.govt.nz/profs/PUArticles/March2017/MedicinesAndHepatitisB.htm.
Rituximab and Hepatitis B Reactivation Prescriber Update 34(3):27 September 2013 https://www.medsafe.govt.nz/profs/PUArticles/Sept2013RituximabHepB.htm.
* 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.