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Home > LEU HCL - cladribine and RITUximab

LEU HCL - cladribine and RITUximab

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 - 42 days

Cycle length:
42

RITUximab:

  • First dose: Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • Subsequent doses: Consider administering corticosteroid premedication before RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.
  • This regimen includes 6 doses of RITUximab to align with Pharmac Special Authority criteria.

Cycle details

Cycle 1 - 42 days

Medication Dose Route Days Max Duration
paracetamol 1000 mg flat dosing oral administration 1, 8, 15,
22, 29, 36
loratadine * 10 mg oral administration 1, 8, 15,
22, 29, 36
dexamethasone * 12 mg flat dosing intravenous 1 15 minutes
RITUximab * 375 mg/m² intravenous 1, 8, 15,
22, 29, 36		 6 hours
cladribine * 0.15 mg/kg Once daily intravenous 1 to 5 120 minutes

RITUximab:

  • First dose: Consider withholding routine anti-hypertensives for 12 hours prior to first RITUximab dose.
  • Subsequent doses: Consider administering corticosteroid premedication before RITUximab if previous doses not well tolerated or if clinically indicated as per institutional practice.
  • This regimen includes 6 doses of RITUximab to align with Pharmac Special Authority criteria.

Full details

Cycle 1 - 42 days

Day: 1

Medication Dose Route Max duration Details
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.
dexamethasone * 12 mg flat dosing intravenous 15 minutes
Instructions:

30 to 60 minutes prior to RITUximab, or as per institutional practice.
RITUximab * 375 mg/m² intravenous 6 hours
Instructions:
  • Consider withholding routine anti-hypertensives for 12 hours prior to RITUximab.
  • 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.
cladribine * 0.15 mg/kg Once daily intravenous 120 minutes

Day: 2

Medication Dose Route Max duration Details
cladribine * 0.15 mg/kg Once daily intravenous 120 minutes

Day: 3

Medication Dose Route Max duration Details
cladribine * 0.15 mg/kg Once daily intravenous 120 minutes

Day: 4

Medication Dose Route Max duration Details
cladribine * 0.15 mg/kg Once daily intravenous 120 minutes

Day: 5

Medication Dose Route Max duration Details
cladribine * 0.15 mg/kg Once daily intravenous 120 minutes

Day: 8

Medication Dose Route Max duration Details
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: 15

Medication Dose Route Max duration Details
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: 22

Medication Dose Route Max duration Details
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: 29

Medication Dose Route Max duration Details
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: 36

Medication Dose Route Max duration Details
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.

Supportive Care Factors

Factor Value
Antifungal prophylaxis: Routine antifungal prophylaxis may be considered
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: Minimal
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Irradiated blood components: Irradiation of blood components is recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis may be considered

References

Chihara D, Arons E, Stetler-Stevenson M, et al. Randomized Phase II Study of First-Line Cladribine With Concurrent or Delayed Rituximab in Patients With Hairy Cell Leukemia. J Clin Oncol. 2020;38(14):1527-1538. , PMID: 32109194

Kreitman RJ, Wilson W, et al. Cladribine with immediate rituximab for the treatment of patients with variant hairy cell leukemia. Clin Cancer Res. 2013 Dec 15;19(24):6873-81. doi: 10.1158/1078-0432.CCR-13-1752. Epub 2013 Nov 25., PMID: 24277451

Goodman, G. R., C. Burian, J. A. Koziol, et al. 2003. "Extended follow-up of patients with hairy cell leukemia after treatment with cladribine." J Clin Oncol 21(5):891-896. , PMID: 12610190

Hoffman, M. A., D. Janson, E. Rose, et al. 1997. "Treatment of hairy-cell leukemia with cladribine: response, toxicity, and long-term follow-up." J.Clin Oncol. 15(3):1138-1142. , PMID: 9060556

Piro, L. D., C. J. Carrera, D. A. Carson, et al. 1990. "Lasting remissions in hairy-cell leukemia induced by a single infusion of 2-chlorodeoxyadenosine." N Engl J Med 322(16):1117-1121. , PMID: 1969613

Saven, A., C. Burian, J. A. Koziol, et al. 1998. "Long-term follow-up of patients with hairy cell leukemia after cladribine treatment." Blood. 92(6):1918-1926. , PMID: 9731048

Zenhausern, R., S. F. Schmitz, M. Solenthaler, et al. 2009. "Randomized trial of daily versus weekly administration of 2-chlorodeoxyadenosine in patients with hairy cell leukemia: a multicenter phase III trial (SAKK 32/98)." Leuk Lymphoma 50(9):1501-1511. , PMID: 19672771

Zinzani, P. L., M. Tani, E. Marchi, V. Stefoni, L. Alinari, G. Musuraca, A. Gabriele, S. Pileri and M. Baccarani. 2004. "Long-term follow-up of front-line treatment of hairy cell leukemia with 2-chlorodeoxyadenosine." Haematologica 89(3):309-313. , PMID: 15020269

Lauria, F., M. Bocchia, G. Marotta, D. Raspadori, P. L. Zinzani and D. Rondelli. 1999. "Weekly administration of 2-chlorodeoxyadenosine in patients with hairy-cell leukemia is effective and reduces infectious complications." Haematologica. 84(1):22-25. , PMID: 10091389

Juliusson, G., D. Heldal, E. Hippe, et al. 1995. "Subcutaneous injections of 2-chlorodeoxyadenosine for symptomatic hairy cell leukemia." J.Clin Oncol. 13(4):989-995. , PMID: 7707128

Grever, M. R., O. Abdel-Wahab, L. A. Andritsos, et al. 2017. "Consensus guidelines for the diagnosis and management of patients with classic hairy cell leukemia." Blood 129(5):553-560. , PMID: 27903528

Liliemark, J., F. Albertioni, M. Hassan, et al. 1992. "On the bioavailability of oral and subcutaneous 2-chloro-2'-deoxyadenosine in humans: alternative routes of administration." J.Clin Oncol. 10(10):1514-1518. , PMID: 1357107

Ravandi, F., S. O'Brien, J. Jorgensen, et al. 2011. "Phase 2 study of cladribine followed by rituximab in patients with hairy cell leukemia." Blood 118(14):3818-3823. , PMID: 21821712

New Zealand Blood Service Transfusion Medicine Handbook Third Edition, 2016 https://www.nzblood.co.nz/assets/Transfusion-Medicine/PDFs/111G122.pdf (accessed 3/2/2022).

Novartis New Zealand Limited Riximyo New Zealand Datasheet 6 July 2020 https://www.medsafe.govt.nz/profs/datasheet/r/riximyoinf.pdf (Accessed 29 March 2022).

Clinect NZ Pty Limited New Zealand datasheet 23 March 2022 https://www.medsafe.govt.nz/profs/Datasheet/l/Leustatininf.pdf (Accessed 13 April 2022).

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

Laudati C, Clark C, Knezevic A, Zhang Z, Barton-Burke M. Hypersensitivity Reactions: Priming Practice Change to Reduce Incidence in First-Dose Rituximab Treatment. Clin J Oncol Nurs. 2018 Aug 1;22(4):407-414. doi: 10.1188/18.CJON.407-414. , PMID: 30035788

Doyle J, Raggatt M, Slavin M, McLachlan SA, Strasser SI, Sasadeusz JJ, Howell J, Hajkowicz K, Nandurkar H, Johnston A, Bak N, Thompson AJ. Hepatitis B management during immunosuppression for haematological and solid organ malignancies: an Australian consensus statement. Med J Aust. 2019 Jun;210(10):462-468. doi: 10.5694/mja2.50160. Epub 2019 May 19., PMID: 31104328

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

Regimen details sometimes vary slightly from the published literature after recommendation by expert committee consensus.

* 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.