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Home > LEU ALL precursor B-cell BCR-ABL1+ - UKALL14 with RITUximab and daSATinib [not for transplant] > LEU - UKALL14 with RITUximab and daSATinib Phase 1 Induction
This regimen is a component of LEU ALL precursor B-cell BCR-ABL1+ - UKALL14 with RITUximab and daSATinib [not for transplant]

UKALL14 with RITUximab and daSATinib [not for transplant] - Phase 1 Induction (LEU ALL precursor B-cell BCR-ABL1+ - UKALL14 with RITUximab and daSATinib [not for transplant])

Treatment Overview

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 - 28 days

Cycle length:
28

daSATinib: Take continuously during treatment, an increase or reduction of dose is recommended based on individual patient response and tolerability.


RITUximab, first dose:

  • Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • For patients at high risk of infusion-related reaction, consider additional pre-medications such as an extra antihistamine dose the day before, an H2 receptor antagonist and montelukast.

RITUximab, Day 24:

  • Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.

Intrathecal metHOTREXATe:

  • As per regimen above (1 dose, Day 14 +/- 3 days) is for CNS prophylaxis, escalation to a treatment strategy will be required for CNS disease or traumatic lumbar puncture.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Cycle details

Cycle 1 - 28 days

Medication Dose Route Days Max Duration
daSATinib 140 mg Once daily oral administration 1 to 28
DAUNOrubicin * 30 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
paracetamol * 1000 mg flat dosing oral administration 3, 10, 17,
24
loratadine * 10 mg oral administration 3, 10, 17,
24
RITUximab * 375 mg/m² intravenous 3, 10, 17,
24		 6 hours
metHOTREXATe 12 mg flat dosing intrathecal injection 14

daSATinib: Take continuously during treatment, an increase or reduction of dose is recommended based on individual patient response and tolerability.


RITUximab, first dose:

  • Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • For patients at high risk of infusion-related reaction, consider additional pre-medications such as an extra antihistamine dose the day before, an H2 receptor antagonist and montelukast.

RITUximab, Day 24:

  • Consider administering corticosteroid premedication prior to RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.

Intrathecal metHOTREXATe:

  • As per regimen above (1 dose, Day 14 +/- 3 days) is for CNS prophylaxis, escalation to a treatment strategy will be required for CNS disease or traumatic lumbar puncture.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Full details

Cycle 1 - 28 days

Day: 1

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
DAUNOrubicin * 30 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:
  • Diluted in a minibag.
  • FOR INTRAVENOUS USE ONLY – fatal if given by any other routes.
  • Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.
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:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
dexamethasone 10 mg/m² Once daily Cap dose per administration at: 20 mg oral administration
Instructions:

Take in the morning with food.

Day: 3

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
dexamethasone 10 mg/m² Once daily Cap dose per administration at: 20 mg oral administration
Instructions:

Take in the morning with food, at least 30 to 60 minutes prior to RITUximab.
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:

First administration: 

  • Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • For patients at high risk of infusion-related reaction, consider additional pre-medications such as an extra antihistamine dose the day before, an H2 receptor antagonist and montelukast.
  • Start infusion at 50 mg/hour. If tolerated, rate can be increased by 50 mg/hour every 30 minutes to a maximum rate of 400 mg/hour.

Day: 4

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
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:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 6

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 7

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 8

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
DAUNOrubicin * 30 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:
  • Diluted in a minibag.
  • FOR INTRAVENOUS USE ONLY – fatal if given by any other routes.
  • Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.
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:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
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:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
dexamethasone 10 mg/m² Once daily Cap dose per administration at: 20 mg oral administration
Instructions:

Take in the morning with food, at least 30 to 60 minutes prior to RITUximab.
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.

Day: 11

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
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:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 13

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 14

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
metHOTREXATe 12 mg flat dosing intrathecal injection
Instructions:
  • Day of administration can be moved +/- 3 days.
  • Adhere to local institution policy for intrathecal administration.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

Day: 15

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
DAUNOrubicin * 30 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:
  • Diluted in a minibag.
  • FOR INTRAVENOUS USE ONLY – fatal if given by any other routes.
  • Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.
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:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
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:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
dexamethasone 10 mg/m² Once daily Cap dose per administration at: 20 mg oral administration
Instructions:

Take in the morning with food, at least 30 to 60 minutes prior to RITUximab.
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.

Day: 18

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
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:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 20

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 21

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 22

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
DAUNOrubicin * 30 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:
  • Diluted in a minibag.
  • FOR INTRAVENOUS USE ONLY – fatal if given by any other routes.
  • Warning vesicant—ensure vein is patent prior to administration, administer vesicant as per institutional policy and monitor for signs of extravasation throughout administration.

Day: 23

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 24

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.
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:
  • Consider administering corticosteroid premedication before RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.
  • 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.

Day: 25

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 26

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 27

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

Day: 28

Medication Dose Route Max duration Details
daSATinib 140 mg Once daily oral administration
Instructions:
  • Swallow whole, do not crush or chew with a large glass of water. Take at the same time each day.
  • Grapefruit or grapefruit juice may interact with this medicine. Discuss with your pharmacist.
  • Dose increase or reduction is recommended based on individual patient response and tolerability.

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
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 

 

Constipation/Diarrhoea risk: vinCRISTine may cause constipation and daSATinib may cause diarrhoea. Monitor gastrointestinal symptoms. 


Emetogenicity: MEDIUM days 1, 8, 15 and 22; MINIMAL to LOW (daSATinib).


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

Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AMM, Eniu A, Jassem J, Pentheroudakis G, Peters S, Rauh S, Zielinski CC, Stahel RA, Voest E, Douillard JY, McGregor K, Ciardiello F. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142., PMID: 28848668

Lyman GH, Balaban E, Diaz M, Ferris A, Tsao A, Voest E, Zon R, Francisco M, Green S, Sherwood S, Harvey RD, Schilsky RL. American Society of Clinical Oncology Statement: Biosimilars in Oncology. J Clin Oncol. 2018 Apr 20;36(12):1260-1265. doi: 10.1200/JCO.2017.77.4893. Epub 2018 Feb 14., PMID: 29443651

* 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.