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Home > HSCT Autologous conditioning - CBV [CYCLOPHOSPHamide, carmustine and etoposide] [lymphoma]

HSCT Autologous conditioning - CBV [CYCLOPHOSPHamide, carmustine and etoposide] [lymphoma]

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 - 60 days

Cycle length:
60

Hydration in addition to that specified is recommended as per institutional practice and may need an individualised approach.


carmustine, etoposide, and CYCLOPHOSPHamide:

  • Dose adjustment for patients weight may be required.
  • See Dosing for bodyweight in Additional details.
  • Refer to latest literature or access https://anztct.org.au (registration required).

CYCLOPHOSPHamide:

  • Monitor for syndrome of inappropriate secretion of ADH with high dose CYCLOPHOSPHamide.

filgrastim: Give filgrastim 5 microgram/kg subcutaneously ONCE daily from day 5 until engraftment.

Cycle details

Cycle 1 - 60 days

Medication / Procedure Dose Route Days Max Duration
carmustine * 450 mg/m² intravenous -6 Min: 180 minutes
etoposide (as phosphate) * 60 mg/kg intravenous -4 Min: 4 hours
sodium chloride 0.9 % intravenous -2 120 minutes
mesna 100 mg/kg intravenous -2 24 hours
CYCLOPHOSPHamide * 100 mg/kg intravenous -2 Min: 120 minutes
sodium chloride 0.9 % intravenous -2 120 minutes
paracetamol * 1000 mg flat dosing oral administration 0
proMETHazine * 12.5 mg intravenous 0 1 minutes
Autologous stem cell transplant intravenous 0
filgrastim 5 microgram/kg Once daily subcutaneous injection 5

Hydration in addition to that specified is recommended as per institutional practice and may need an individualised approach.


carmustine, etoposide, and CYCLOPHOSPHamide:

  • Dose adjustment for patients weight may be required.
  • See Dosing for bodyweight in Additional details.
  • Refer to latest literature or access https://anztct.org.au (registration required).

CYCLOPHOSPHamide:

  • Monitor for syndrome of inappropriate secretion of ADH with high dose CYCLOPHOSPHamide.

filgrastim: Give filgrastim 5 microgram/kg subcutaneously ONCE daily from day 5 until engraftment.

Full details

Cycle 1 - 60 days

Day: -6

Medication Dose Route Max duration Details
carmustine * 450 mg/m² intravenous Min: 180 minutes
Instructions:

Dose adjustment for patients weight may be required, see Dosing for bodyweight, below.

  • Do not exceed an infusion rate of 3 mg/m2 per minute.
  • Prepare solution in PVC-free bag and administer via polyethylene lined administration set.
  • Protect bag and administration line from light.
Additional details:

Day: -4

Medication Dose Route Max duration Details
etoposide (as phosphate) * 60 mg/kg intravenous Min: 4 hours
Instructions:

Dose adjustment for patients weight may be required, see Dosing for bodyweight, below.

Additional details:

Day: -2

Medication Dose Route Max duration Details
sodium chloride 0.9 % intravenous 120 minutes
Quantity:1000 mL
Instructions:

Prior to CYCLOPHOSPHamide infusion.
mesna 100 mg/kg intravenous 24 hours
Instructions:

Continuous infusion over 24 hours starting ONE hour before the CYCLOPHOSPHamide infusion, or as per institutional practice.
CYCLOPHOSPHamide * 100 mg/kg intravenous Min: 120 minutes
Instructions:

Dose adjustment for patients weight may be required, see Dosing for bodyweight, below.

  • Consider hydration with at least 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.
Additional details:
sodium chloride 0.9 % intravenous 120 minutes
Quantity:1000 mL
Instructions:

After CYCLOPHOSPHamide infusion.

Day: 0

Medication / Procedure Dose Route Max duration Details
paracetamol * 1000 mg flat dosing oral administration
Instructions:

ONE hour prior to return of autologous stem cells, or as per institutional practice.
proMETHazine * 12.5 mg intravenous 1 minutes
Instructions:

ONE hour prior to return of autologous stem cells, or as per institutional practice.
Autologous stem cell transplant intravenous
Instructions:

Administer as per institutional practice.

Day: 5

Medication Dose Route Max duration Details
filgrastim 5 microgram/kg Once daily subcutaneous injection
Instructions:

Give ONCE daily from Day 5 until engraftment.

  • Round dose to nearest prefilled syringe dose of 300 micrograms or 480 micrograms.

Additional details

Section 1: Dosing for bodyweight

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
Gastroprotection: Gastroprotection may be considered
Growth factor support: Recommended for primary prophylaxis
Hydration: Routine hydration recommended
Hypersensitivity / Infusion related reaction risk: High - routine premedication recommended
Irradiated blood components: Irradiation of blood components is recommended
Mesna uroprotection: Routine mesna uroprotection recommended
Pneumocystis jirovecii pneumonia (PJP) prophylaxis: Routine antibiotic prophylaxis recommended
Sinusoidal obstruction syndrome prophylaxis: Sinsuoidal obstruction prophylaxis may be considered
Tumour lysis syndrome prophylaxis: Tumour lysis syndrome prophylaxis may be considered

Emetogenicity: HIGH day -6 and -2; LOW day -4.

References

Chen, Y. B., A. A. Lane, B. R. Logan, et al. 2015. "Impact of conditioning regimen on outcomes for patients with lymphoma undergoing high-dose therapy with autologous hematopoietic cell transplantation." Biol Blood Marrow Transplant 21(6):1046-1053., PMID: 25687795

Salar A, Sierra J, Gandarillas M et al. 2001"Autologous stem cell transplantation for clinically aggressive non-Hodgkin's lymphoma: the role of preparative regimens" Bone Marrow Transplant. Feb;27(4):405-12., PMID: 11313670

Robertson, M. J., R. Abonour, R. Hromas, et al. 2005. "Augmented high-dose regimen of cyclophosphamide, carmustine, and etoposide with autologous hematopoietic stem cell transplantation for relapsed and refractory aggressive non-Hodgkin's lymphoma." Leuk Lymphoma 46(10):1477-1487., PMID: 16194894

Horning SJ, Chao NJ, Negrin RS, Hoppe RT, Long GD, Hu WW, Wong RM, Brown BW, Blume KG. High-dose therapy and autologous hematopoietic progenitor cell transplantation for recurrent or refractory Hodgkin's disease: analysis of the Stanford University results and prognostic indices. Blood. 1997 Feb 1;89(3):801-13., PMID: 9028311

Lazarus, H. M., F. R. Loberiza, Jr., M. J. Zhang, et al. 2001. "Autotransplants for Hodgkin's disease in first relapse or second remission: a report from the autologous blood and marrow transplant registry (ABMTR)." Bone Marrow Transplant 27(4):387-396., PMID: 11313668

Wheeler, C., A. Khurshid, J. Ibrahim, et al. 2001. "Incidence of post transplant myelodysplasia/acute leukemia in non-Hodgkin's lymphoma patients compared with Hodgkin's disease patients undergoing autologous transplantation following cyclophosphamide, carmustine, and etoposide (CBV)." Leuk Lymphoma 40(5-6):499-509., PMID: 11426523

Lane, A. A., P. Armand, Y. Feng, et al. 2012. "Risk factors for development of pneumonitis after high-dose chemotherapy with cyclophosphamide, BCNU and etoposide followed by autologous stem cell transplant." Leuk Lymphoma 53(6):1130-1136., PMID: 22132836

Puig, N., De La Rubia, J., Remigia M, et al. 2006. "Morbidity and transplant-related mortality of CBV and BEAM preparative regimens for patients with lymphoid malignancies undergoing autologous stem-cell transplantation." Leukemia and Lymphoma. Aug;47(8):1488-94., PMID: 16966258

Emcure NZ Limited BiCNU New Zealand Datasheet 29 April 2020 https://www.medsafe.govt.nz/profs/Datasheet/b/bicnuinj.pdf.

Bubalo J, Carpenter PA, et al; American Society for Blood and Marrow Transplantation practice guideline committee. Conditioning chemotherapy dose adjustment in obese patients: a review and position statement by the American Society for Blood and Marrow Transplantation practice guideline committee. Biol Blood Marrow Transplant. 2014 May;20(5):600-16. doi: 10.1016/j.bbmt.2014.01.019. Epub 2014 Jan 23., PMID: 24462742

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

New Zealand Blood Service Transfusion Medicine Handbook Third Edition, 2016 https://www.nzblood.co.nz/assets/Transfusion-Medicine/PDFs/111G122.pdf (accessed 16 June 2022).

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

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.