Systemic Anti-Cancer Therapy Regimen Library
UKALL14 with RITUximab and daSATinib [not for transplant] - Consolidation/delayed intensification [Cycle 3] (LEU ALL precursor B-cell BCR-ABL1+ - UKALL14 with RITUximab and daSATinib [not for transplant])
Treatment Overview
Starts after count recovery from Consolidation Cycle 2. Day 29 should be delayed if necessary until count recovery.
Count recovery is defined as:
- Neutrophils greater than 0.75 x 109/L, and
- Platelets greater than 75 x 109/L.
This regimen contains a medicine where one or more biosimilars may exist. Any biosimilars used have been reviewed by the regulator (Medsafe) and relevant specialists were consulted nationally. Where regulators, in consultation with relevant specialists, have agreed that there are no clinically significant differences in either safety or effectiveness between a biosimilar and originator product, these drugs may be used interchangeably.
Cycle 1 - 42 days
Day 29 should be delayed if necessary until count recovery, with neutrophils greater than 0.75 x 109/L and platelets greater than 75 x 109/L.
daSATinib: Take continuously during treatment, an increase or reduction of dose is recommended based on individual patient response and tolerability.
Intrathecal metHOTREXATe:
- Day of administration can be moved +/- 3 days.
- For Ommaya reservoir reduce dose to 6 mg intraventricularly.
mercaptOPURine: Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine: Administer by subcutaneous injection (as above) or alternatively administer intravenously as per institutional practice.
Cycle details
Cycle 1 - 42 days
Medication | Dose | Route | Days | Max Duration |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration | 1 to 42 | |
DAUNOrubicin * | 25 mg/m² | intravenous | 1, 8, 15, 22 |
20 minutes |
vinCRISTine | 1.4 mg/m² Cap dose per administration at: 2 mg | intravenous | 1, 8, 15, 22 |
10 minutes |
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration | 1 to 4, 8 to 11, 15 to 18, 22 to 25 |
|
paracetamol * | 1000 mg flat dosing | oral administration | 2 | |
loratadine * | 10 mg | oral administration | 2 | |
RITUximab * | 375 mg/m² | intravenous | 2 | 6 hours |
metHOTREXATe | 12 mg flat dosing | intrathecal injection | 2, 17 | |
CYCLOPHOSPHamide | 1000 mg/m² | intravenous | 29 | 60 minutes |
mercaptOPURine | 60 mg/m² Once daily | oral administration | 29 to 42 | |
cytarabine | 75 mg/m² Once daily | subcutaneous injection | 30 to 33, 37 to 40 |
Day 29 should be delayed if necessary until count recovery, with neutrophils greater than 0.75 x 109/L and platelets greater than 75 x 109/L.
daSATinib: Take continuously during treatment, an increase or reduction of dose is recommended based on individual patient response and tolerability.
Intrathecal metHOTREXATe:
- Day of administration can be moved +/- 3 days.
- For Ommaya reservoir reduce dose to 6 mg intraventricularly.
mercaptOPURine: Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine: Administer by subcutaneous injection (as above) or alternatively administer intravenously as per institutional practice.
Full details
Cycle 1 - 42 days
Day: 1
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
DAUNOrubicin * | 25 mg/m² | intravenous | 20 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. |
vinCRISTine | 1.4 mg/m² Cap dose per administration at: 2 mg | intravenous | 10 minutes |
Instructions:
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 2
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
|
paracetamol * | 1000 mg flat dosing | oral administration |
Instructions:
30 to 60 minutes prior to RITUximab. |
|
loratadine * | 10 mg | oral administration |
Instructions:
30 to 60 minutes prior to RITUximab. |
|
RITUximab * | 375 mg/m² | intravenous | 6 hours |
Instructions:
Start infusion at 100 mg/hour. If tolerated, rate can be increased by 100 mg/hour every 30 minutes to a maximum rate of 400 mg/hour, or as per institutional practice. |
metHOTREXATe | 12 mg flat dosing | intrathecal injection |
Instructions:
|
Day: 3
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 4
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 5
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 6
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 7
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 8
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
DAUNOrubicin * | 25 mg/m² | intravenous | 20 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. |
vinCRISTine | 1.4 mg/m² Cap dose per administration at: 2 mg | intravenous | 10 minutes |
Instructions:
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 9
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 10
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 11
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 12
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 13
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 14
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 15
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
DAUNOrubicin * | 25 mg/m² | intravenous | 20 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. |
vinCRISTine | 1.4 mg/m² Cap dose per administration at: 2 mg | intravenous | 10 minutes |
Instructions:
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 16
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 17
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
|
metHOTREXATe | 12 mg flat dosing | intrathecal injection |
Instructions:
|
Day: 18
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 19
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 20
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 21
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 22
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
DAUNOrubicin * | 25 mg/m² | intravenous | 20 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. |
vinCRISTine | 1.4 mg/m² Cap dose per administration at: 2 mg | intravenous | 10 minutes |
Instructions:
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 23
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 24
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 25
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
dexamethasone | 10 mg/m² Once daily Cap dose per administration at: 20 mg | oral administration |
Instructions:
Take in the morning with food. |
Day: 26
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 27
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 28
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
Day: 29
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
CYCLOPHOSPHamide | 1000 mg/m² | intravenous | 60 minutes |
Instructions:
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
Day: 30
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
|
cytarabine | 75 mg/m² Once daily | subcutaneous injection |
Instructions:
Or administer intravenously as per institutional practice. |
Day: 31
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
|
cytarabine | 75 mg/m² Once daily | subcutaneous injection |
Instructions:
Or administer intravenously as per institutional practice. |
Day: 32
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
|
cytarabine | 75 mg/m² Once daily | subcutaneous injection |
Instructions:
Or administer intravenously as per institutional practice. |
Day: 33
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
|
cytarabine | 75 mg/m² Once daily | subcutaneous injection |
Instructions:
Or administer intravenously as per institutional practice. |
Day: 34
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
Day: 35
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
Day: 36
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
Day: 37
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
|
cytarabine | 75 mg/m² Once daily | subcutaneous injection |
Instructions:
Or administer intravenously as per institutional practice. |
Day: 38
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
|
cytarabine | 75 mg/m² Once daily | subcutaneous injection |
Instructions:
Or administer intravenously as per institutional practice. |
Day: 39
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
|
cytarabine | 75 mg/m² Once daily | subcutaneous injection |
Instructions:
Or administer intravenously as per institutional practice. |
Day: 40
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
|
cytarabine | 75 mg/m² Once daily | subcutaneous injection |
Instructions:
Or administer intravenously as per institutional practice. |
Day: 41
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
Day: 42
Medication | Dose | Route | Max duration | Details |
---|---|---|---|---|
daSATinib | 140 mg Once daily | oral administration |
Instructions:
|
|
mercaptOPURine | 60 mg/m² Once daily | oral administration |
Instructions:
|
Supportive Care Factors
Factor | Value |
---|---|
Antifungal prophylaxis: | Routine antifungal prophylaxis recommended |
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 |
Gastroprotection: | Gastroprotection is recommended |
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 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.
Emetogenicity: MEDIUM days 1, 8, 15, 22 and 29; MINIMAL to LOW days 2 to 42 excluding days 8, 15, 22 and 29.
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
* 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.