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Home > LEU ALL precursor B-cell - UKALL14 with RITUximab [over 40 years] [not for transplant] > LEU - UKALL14 with RITUximab [not for transplant] Phase 2 Induction
This regimen is a component of LEU ALL precursor B-cell - UKALL14 with RITUximab [over 40 years] [not for transplant]

UKALL14 with RITUximab [over 40 years] [not for transplant] - Phase 2 Induction (LEU ALL precursor B-cell - UKALL14 with RITUximab [over 40 years] [not for transplant])

Treatment Overview

Starts after count recovery from Phase 1 Induction, with 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 - 28 days

Cycle length:
28

mercaptOPURine: Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.


Intrathecal metHOTREXATe:

  • Day of administration can be moved +/- 3 days.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

cytarabine: Administer by subcutaneous injection (as above) or alternatively administer intravenously as per institutional practice.


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

Cycle details

Cycle 1 - 28 days

Medication Dose Route Days Max Duration
CYCLOPHOSPHamide 1000 mg/m² intravenous 1, 15 60 minutes
mercaptOPURine 60 mg/m² Once daily oral administration 1 to 28
metHOTREXATe 12 mg flat dosing intrathecal injection 1, 8, 15,
22
cytarabine 75 mg/m² Once daily subcutaneous injection 2 to 5,
9 to 12,
16 to 19,
23 to 26
paracetamol * 1000 mg flat dosing oral administration 2, 16
loratadine * 10 mg oral administration 2, 16
RITUximab * 375 mg/m² intravenous 2, 16 6 hours

mercaptOPURine: Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.


Intrathecal metHOTREXATe:

  • Day of administration can be moved +/- 3 days.
  • For Ommaya reservoir reduce dose to 6 mg intraventricularly.

cytarabine: Administer by subcutaneous injection (as above) or alternatively administer intravenously as per institutional practice.


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

Full details

Cycle 1 - 28 days

Day: 1

Medication Dose Route Max duration Details
CYCLOPHOSPHamide 1000 mg/m² intravenous 60 minutes
Instructions:

Consider hydration with at least 2000 to 3000 ml over 24 hours as oral or IV fluid on day(s) of CYCLOPHOSPHamide and for 24 hours after or as per institutional practice.
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
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: 2

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
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: 3

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 4

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 5

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 6

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 7

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 8

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
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: 9

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 10

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 11

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 12

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 13

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 14

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 15

Medication Dose Route Max duration Details
CYCLOPHOSPHamide 1000 mg/m² intravenous 60 minutes
Instructions:

Consider hydration with at least 2000 to 3000 ml over 24 hours as oral or IV fluid on day(s) of CYCLOPHOSPHamide and for 24 hours after or as per institutional practice.
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
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: 16

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.
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: 17

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 18

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 19

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 20

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 21

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 22

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
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: 23

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 24

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 25

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 26

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.
cytarabine 75 mg/m² Once daily subcutaneous injection
Instructions:

Or administer intravenously as per institutional practice.

Day: 27

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

Day: 28

Medication Dose Route Max duration Details
mercaptOPURine 60 mg/m² Once daily oral administration
Instructions:
  • Take each dose on an empty stomach – one hour before OR three hours after food or milk.
  • Round dose to closest multiple of 25 mg.
  • Consider thiopurine methyltransferase (TPMT) testing and NUDT15 screening for specific patients.

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
Emetogenicity: Variable
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended

Emetogenicity: MEDIUM days 1 and 15; MINIMAL to LOW days 2 to 28, excluding day 15.

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.