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LEU - mAALL1131 with daSATinib Induction [CNS2]
This regimen is a component of LEU ALL precursor B-cell BCR-ABL1+ - modified AALL1131 with daSATinib
mAALL1131 with daSATinib - Induction for CNS 2+ (LEU ALL precursor B-cell BCR-ABL1+ - modified AALL1131 with daSATinib)
Treatment Overview
Use Induction regimen specific for CNS status of patient.
Intrathecal therapy in this regimen intended for patients with CNS2+ disease.
Cycle 1 - 35 days
Cycle length:
35
Intrathecal cytarabine 70 mg:
- May be given at the time of diagnostic lumbar puncture (up to 72 hours prior to start of Induction), or on day 1.
Intrathecal cytarabine 40 mg:
- For 2 doses, administer 1 dose on day 4 or 5 or 6 and 1 dose on day 11 or 12.
- If CSF remains positive for blasts, additional twice weekly doses are required (excluding days 8 and 29 when intrathecal metHOTREXATe is given). Continued until 3 consecutive CSF are clear of blasts. Consult protocol for 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.
Intrathecal metHOTREXATe: For Ommaya reservoir reduce dose to 6 mg intraventricularly.
daSATinib: Dose increase or reduction is recommended based on patient response and tolerability.
Cycle details
Cycle 1 - 35 days
| Medication | Dose | Route | Days | Max Duration |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration | 1 to 28 | |
| cytarabine | 70 mg flat dosing | intrathecal injection | 1 | |
| vinCRISTine * | 1.5 mg/m² Cap dose per administration at: 2 mg | intravenous | 1, 8, 15, 22 |
10 minutes |
| DAUNOrubicin * | 25 mg/m² | intravenous | 1, 8, 15, 22 |
15 minutes |
| paracetamol * | 1000 mg flat dosing | oral administration | 4 | |
| loratadine * | 10 mg | oral administration | 4 | |
| famotidine * | 20 mg | oral administration | 4 | |
| pegaspargase * | 2500 international unit/m² | intravenous | 4 | 120 minutes |
| cytarabine * | 40 mg flat dosing | intrathecal injection | 4, 11 | |
| metHOTREXATe * | 15 mg | intrathecal injection | 8, 29 | |
| daSATinib | 140 mg Once daily | oral administration | 15 to 35 |
Intrathecal cytarabine 70 mg:
- May be given at the time of diagnostic lumbar puncture (up to 72 hours prior to start of Induction), or on day 1.
Intrathecal cytarabine 40 mg:
- For 2 doses, administer 1 dose on day 4 or 5 or 6 and 1 dose on day 11 or 12.
- If CSF remains positive for blasts, additional twice weekly doses are required (excluding days 8 and 29 when intrathecal metHOTREXATe is given). Continued until 3 consecutive CSF are clear of blasts. Consult protocol for 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.
Intrathecal metHOTREXATe: For Ommaya reservoir reduce dose to 6 mg intraventricularly.
daSATinib: Dose increase or reduction is recommended based on patient response and tolerability.
Full details
Cycle 1 - 35 days
Day: 1
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| cytarabine | 70 mg flat dosing | intrathecal injection |
Instructions:
|
|
| vinCRISTine * | 1.5 mg/m² Cap dose per administration at: 2 mg | intravenous | 10 minutes |
Instructions:
|
| DAUNOrubicin * | 25 mg/m² | intravenous | 15 minutes |
Instructions:
Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration. |
Day: 2
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
Day: 3
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
Day: 4
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| 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:
Additional details:
|
| cytarabine * | 40 mg flat dosing | intrathecal injection |
Instructions:
|
Day: 5
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
Day: 6
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
Day: 7
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
Day: 8
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| vinCRISTine * | 1.5 mg/m² Cap dose per administration at: 2 mg | intravenous | 10 minutes |
Instructions:
|
| DAUNOrubicin * | 25 mg/m² | intravenous | 15 minutes |
Instructions:
Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration. |
| metHOTREXATe * | 15 mg | intrathecal injection |
Instructions:
|
Day: 9
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
Day: 10
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
Day: 11
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| cytarabine * | 40 mg flat dosing | intrathecal injection |
Instructions:
|
Day: 12
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
Day: 13
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
Day: 14
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
Day: 15
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| vinCRISTine * | 1.5 mg/m² Cap dose per administration at: 2 mg | intravenous | 10 minutes |
Instructions:
|
| DAUNOrubicin * | 25 mg/m² | intravenous | 15 minutes |
Instructions:
Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration. |
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 16
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 17
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 18
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 19
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 20
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 21
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 22
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| vinCRISTine * | 1.5 mg/m² Cap dose per administration at: 2 mg | intravenous | 10 minutes |
Instructions:
|
| DAUNOrubicin * | 25 mg/m² | intravenous | 15 minutes |
Instructions:
Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration. |
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 23
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 24
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 25
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 26
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 27
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 28
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| prEDNISone | 30 mg/m² Twice daily | oral administration |
Instructions:
Take with food. Do not taper. |
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 29
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| metHOTREXATe * | 15 mg | intrathecal injection |
Instructions:
|
|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 30
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 31
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 32
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 33
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 34
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 35
| Medication | Dose | Route | Max duration | Details |
|---|---|---|---|---|
| daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
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.
- 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: | Variable |
| Diarrhoea risk: | Variable |
| Emetogenicity: | Variable |
| Gastroprotection: | Gastroprotection is recommended |
| Hypersensitivity / Infusion related reaction risk: | High - routine premedication recommended |
| Pneumocystis jirovecii pneumonia (PJP) prophylaxis: | Routine antibiotic prophylaxis recommended |
| Tumour lysis syndrome prophylaxis: | Tumour lysis syndrome prophylaxis is recommended |
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.
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.
Diarrhoea/Constipation risk: daSATinib may cause diarrhoea and vinCRISTine may cause constipation. Monitor gastrointestinal symptoms.
Emetogenicity:
- MEDIUM days 1, 8, 15, 22;
- MINIMAL day 4;
- MINIMAL to LOW (daSATinib).
Gastroprotection:
- Gastroprotective agents are only intended for short term use while patient is receiving corticosteroid treatment doses.
- 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.
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.