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Peripheral blood stem cell (PBSC) mobilisation CYCLOPHOSPHamide

This protocol was published over 10 years ago and has been assessed by the reference committee as suitable to be reviewed as required. The review due date has been removed. If something in this protocol requires reference committee consideration, please click on the feedback button at the bottom of the page.

Read more about the as required review process in this factsheet.

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Drug Dose Route Day
Mesna 3,000 mg/m2 * IV infusion 1
CYCLOPHOSPHamide 3,000 mg/m2 * IV infusion 1
Filgrastim 10 micrograms/kg (in divided doses) Subcut 3 and continue daily until stem cells have been harvested

* Doses of cyclophosphamide range from 2 to 4 g/m2. Guidance as to which dose is most appropriate is detailed in the evidence section below. The dose in this protocol was selected by the eviQ BMT Reference Committee. Please ensure that the mesna dose is suitable for the chosen cyclophosphamide dose. 

Note: hyperhydration can be given in place of mesna as per local guidelinesrr. Please see the haemorrhagic cystitis document for more information. 

The supportive therapies (e.g. antiemetics, premedications, growth factor support etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Day 1
Mesna 3,000 mg/m2 (IV infusion) by continuous IV infusion for 5 hours, starting 1 hour before the cyclophosphamide infusion *
CYCLOPHOSPHamide 3,000 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 60 minutes *
Day 3
Filgrastim 10 micrograms/kg (Subcut) inject subcutaneously in divided doses (morning and evening) until stem cells have been harvested

* Doses of cyclophosphamide range from 2 to 4 g/m2. Guidance as to which dose is most appropriate is detailed in the evidence section below. The dose in this protocol was selected by the eviQ BMT Reference Committee. Please ensure that the mesna dose is suitable for the chosen cyclophosphamide dose. 

Note: hyperhydration can be given in place of mesna as per local guidelinesrr. Please see the haemorrhagic cystitis document for more information. 

Drug Dose Route Day
Mesna 3,000 mg/m2 * IV infusion 1
CYCLOPHOSPHamide 3,000 mg/m2 * IV infusion 1
Filgrastim 10 micrograms/kg (in divided doses) Subcut 3 and continue daily until stem cells have been harvested

* Doses of cyclophosphamide range from 2 to 4 g/m2. Guidance as to which dose is most appropriate is detailed in the evidence section below. The dose in this protocol was selected by the eviQ BMT Reference Committee. Please ensure that the mesna dose is suitable for the chosen cyclophosphamide dose. 

Note: hyperhydration can be given in place of mesna as per local guidelinesrr. Please see the haemorrhagic cystitis document for more information. 

The supportive therapies (e.g. antiemetics, premedications, growth factor support etc.), infusion times, diluents, volumes and routes of administration, if included, are listed as defaults. They may vary between institutions and can be substituted to reflect individual institutional policy.

Antiemetics if included in the treatment schedule are based upon recommendations from national and international guidelines. These are defaults only and may be substituted to reflect individual institutional policy. Select here for recommended doses of alternative antiemetics.

Day 1
Mesna 3,000 mg/m2 (IV infusion) by continuous IV infusion for 5 hours, starting 1 hour before the cyclophosphamide infusion *
CYCLOPHOSPHamide 3,000 mg/m2 (IV infusion) in 500 mL sodium chloride 0.9% over 60 minutes *
Day 3
Filgrastim 10 micrograms/kg (Subcut) inject subcutaneously in divided doses (morning and evening) until stem cells have been harvested

* Doses of cyclophosphamide range from 2 to 4 g/m2. Guidance as to which dose is most appropriate is detailed in the evidence section below. The dose in this protocol was selected by the eviQ BMT Reference Committee. Please ensure that the mesna dose is suitable for the chosen cyclophosphamide dose. 

Note: hyperhydration can be given in place of mesna as per local guidelinesrr. Please see the haemorrhagic cystitis document for more information. 

  • Autologous recipients: mobilisation of peripheral blood stem cells for future stem cell rescue following conditioning therapy
Venous access required

IV cannula (IVC) or central venous access device (CVAD) is required to administer this treatment.

Read more about central venous access device line selection
Antiemetics for multi-day protocols

Patients being treated with multi-day anticancer protocols should receive antiemetics tailored to the emetogenic risk of the drugs administered each day during treatment and for two days after completion of the anticancer protocol.

No standard antiemetic regimen exists for multi-day anticancer protocols, and as such, no antiemetics have been added to the treatment schedule, despite the availability of a PBS approved combination of an NK1 receptor antagonist, 5HT3, and a steroid for preventing nausea and vomiting associated with moderate to highly emetogenic anti-cancer therapies. 

Ensure that patients also have sufficient antiemetics for breakthrough emesis:

Metoclopramide 10 mg three times a day when necessary (maximum of 30 mg/24 hours, up to 5 days) OR

Prochlorperazine 10 mg PO every 6 hours when necessary.

Read more about preventing anti-cancer therapy induced nausea and vomiting
Haemorrhagic cystitis associated with high dose chemotherapy

Hydration regimen pre high dose cyclophosphamide or ifosfamide (as per local guidelines).
There is limited evidence and no consensus regarding hydration regimens and mesna dose, route or timing of administration.

Read more about haemorrhagic cystitis
Hydration

Hydration regimen pre high dose cyclophosphamide (as per local guidelines). Mesna dose and hydration schedule may differ per institution.
Mesna dosing and administration

There is evidence supporting variations in mesna doses and administration timings, with no clear evidence that one particular regimen is superior to another. The eviQ mesna recommendations may be based upon the individual trial/study or reference committee consensus and provide guidance on one safe way to administer the protocol. Individual institutional policy may vary and should be evidence-based.

Read more about haemorrhagic cystitis 
Serology

Baseline screens must be performed 30 days prior to stem cell mobilisation.
Biosimilar drug

Read more about biosimilar drugs on the Biosimilar Awareness Initiative opens in a new tab or window page
Blood product support

All transplant recipients are to receive irradiated blood products. Additionally, those patients who are CMV serologically negative are to receive CMV-negative or leukodepleted blood products (i.e. CMV safe), as dictated by local clinical policies.

Read more about the indications for the use of irradiated blood components opens in a new tab or window and cytomegalovirus (CMV) seronegative components opens in a new tab or window
Blood tests

FBC, EUC, eGFR and LFTs as required each day.
Hepatitis B screening and prophylaxis

Routine screening for HBsAg and anti-HBc is recommended prior to initiation of treatment. Prophylaxis should be determined according to individual institutional policy.

Read more about hepatitis B screening and prophylaxis in cancer patients requiring cytotoxic and/or immunosuppressive therapy
Vaccinations

Live vaccines are contraindicated in cancer patients receiving immunosuppressive therapy and/or who have poorly controlled malignant disease. Possible suboptimal response to inactivated vaccines.

For more information about vaccinations in people with cancer refer to the Australian Immunisation Handbook opens in a new tab or window.
Fertility, pregnancy and lactation

Cancer treatment can have harmful effects on fertility and this should be discussed with all patients of reproductive potential prior to commencing treatment. There is a risk of fetal harm in pregnant women. A pregnancy test should be considered prior to initiating treatment in females of reproductive potential if sexually active. It is important that all patients of reproductive potential use effective contraception whilst on therapy and after treatment finishes. Effective contraception methods and adequate contraception timeframe should be discussed with all patients of reproductive potential. Possibility of infant risk should be discussed with breastfeeding patients.

Read more about the impact of cancer treatment on fertility opens in a new tab or window
Evidence for dose modifications is limited, and the recommendations made on eviQ are intended as a guide only. They are generally conservative with an emphasis on safety. Any dose modification should be based on clinical judgement, and the individual patient’s situation including but not limited to treatment intent (curative vs palliative), the anti-cancer regimen (single versus combination therapy versus chemotherapy versus immunotherapy), biology of the cancer (site, size, mutations, metastases), other treatment related side effects, additional co-morbidities, performance status and patient preferences.Suggested dose modifications are based on clinical trial findings, product information, published guidelines and reference committee consensus . The dose reduction applies to each individual dose and not to the total number of days or duration of treatment cycle unless stated otherwise. Non-haematological gradings are based on Common Terminology Criteria for Adverse Events (CTCAE) opens in a new tab or window unless otherwise specified. Renal and hepatic dose modifications have been standardised where possible. For more information see dosing considerations & disclaimer.
The International Consensus Guideline for Anticancer Drug Dosing in Kidney Dysfunction (ADDIKD) guideline does not address dose adjustment for kidney dysfunction in stem cell mobilisation, bone marrow transplantation and cellular therapies. In these circumstances, the transplant team should be consulted if the patient has kidney dysfunction and is requiring one of the drugs referred to in ADDIKD as part of their treatment.
Renal impairment
Creatinine clearance (mL/min)
less than 30 Consider reducing the dose of cyclophosphamide for mobilisation

Mesna dosing schedule should be repeated each day high-dose cyclophosphamide (50 mg/kg or 2 g/m2) is received. If the cyclophosphamide dose is adjusted (decreased or increased), the intravenous mesna dose should also be modified to maintain the mesna-to-cyclophosphamide ratio (1.0 - 1.5 x the daily dose of cyclophosphamide).r

The drug interactions shown below are not an exhaustive list. For a more comprehensive list and for detailed information on specific drug interactions and clinical management, please refer to the specific drug product information and the following key resources:  

For more information see References & Disclaimer.

Cyclophosphamide
  Interaction Clinical management
CYP3A4 inducers (e.g. carbamazepine, phenytoin, phenobarbitone, rifampicin, St John's wort etc.) Increased toxicity of cyclophosphamide possible due to increased conversion to active (and inactive) metabolites Avoid combination or monitor for cyclophosphamide toxicity
CYP3A4 inhibitors (e.g. aprepitant*, azole antifungals, clarithromycin, erythromycin, grapefruit juice, ritonavir etc.) Reduced efficacy of cyclophosphamide possible due to decreased conversion to active (and inactive) metabolites Avoid combination or monitor for decreased clinical response to cyclophosphamide
Nephrotoxic drugs (e.g. aminoglycosides, amphotericin, contrast dye, frusemide, NSAIDs) Additive nephrotoxicity Avoid combination or monitor kidney function closely
Amiodarone Possible additive pulmonary toxicity with high-dose cyclophosphamide (i.e. doses used prior to stem cell transplant; 60 mg/kg daily or 120 to 270 mg/kg over a few days) Avoid combination or monitor closely for pulmonary toxicity
Allopurinol, hydrochlorothiazide, indapamide Delayed effect. Increased risk of bone marrow depression; probably due to reduced clearance of active metabolites of cyclophosphamide Avoid combination, consider alternative antihypertensive therapy or monitor for myelosuppression
Ciclosporin Reduced efficacy of ciclosporin due to reduced serum concentration Monitor ciclosporin levels; adjust dosage as appropriate; monitor response to ciclosporin; observe patient for signs of acute graft versus host disease
Selective Serotonin Reuptake Inhibitors (SSRI) Combination may increase the risk of SIADH, hyponatraemia. (SIADH more common with doses > 50 mg/kg and may be aggravated by the large volume of fluids administered to prevent haemorrhagic cystitis) Monitor electrolytes and patient for fluid overload and signs of hyponatraemia (dizziness, confusion)
Suxamethonium Prolonged apnoea due to marked and persistent inhibition of cholinesterase by cyclophosphamide Alert the anaesthetist if a patient has been treated with cyclophosphamide within ten days of planned general anaesthesia
* Bubalo JS, Cherala G, McCune JS et al. 2012 "Aprepitant pharmacokinetics and assessing the impact of aprepitant on cyclophosphamide metabolism in cancer patients undergoing hematopoietic stem cell transplantation" J Clin Pharmacol. Apr;52(4):586-94.

Randomised, double-blind placebo-controlled study of 40 patients undergoing BMT with either cyclophosphamide/busulfan or cyclophosphamide/total body irradiation conditioning exposed to aprepitant or placebo 1 hour before the first chemotherapy or radiation treatment showed no significant changes in cyclophosphamide pharmacokinetics, and chemotherapy induced nausea and vomiting were well tolerated. Based on that study, we feel that aprepitant can be used safely with conditioning regimens including cyclophosphamide.
Mesna 
No specific or clinically significant drug interactions 
General
  Interaction Clinical management
Warfarin Anti-cancer drugs may alter the anticoagulant effect of warfarin. Monitor INR regularly and adjust warfarin dosage as appropriate; consider alternative anticoagulant.
Direct oral anticoagulants (DOACs) e.g. apixaban, rivaroxaban, dabigatran

Interaction with both CYP3A4 and P-gp inhibitors /inducers.

DOAC and anti-cancer drug levels may both be altered, possibly leading to loss of efficacy or toxicity (i.e. increased bleeding).

Apixaban: avoid concurrent use with strong CYP3A4 opens in a new tab or window and P‑gp opens in a new tab or window inhibitors. If treating VTE, avoid use with strong CYP3A4 opens in a new tab or window and P‑gp opens in a new tab or window inducers. 

Rivaroxaban: avoid concurrent use with strong CYP3A4 opens in a new tab or window and P‑gp opens in a new tab or window  inhibitors.

Dabigatran: avoid combination with strong P‑gp opens in a new tab or window inducers and inhibitors.

If concurrent use is unavoidable, monitor closely for efficacy/toxicity of both drugs.
Digoxin Anti-cancer drugs can damage the lining of the intestine; affecting the absorption of digoxin. Monitor digoxin serum levels; adjust digoxin dosage as appropriate.
Antiepileptics Both altered antiepileptic and anti-cancer drug levels may occur, possibly leading to loss of efficacy or toxicity. Where concurrent use of an enzyme-inducing antiepileptic cannot be avoided, monitor antiepileptic serum levels for toxicity, as well as seizure frequency for efficacy; adjust dosage as appropriate.
Also monitor closely for efficacy of the anti-cancer therapy.
Antiplatelet agents and NSAIDs Increased risk of bleeding due to treatment related thrombocytopenia. Avoid or minimise combination.
If combination deemed essential, (e.g. low dose aspirin for ischaemic heart disease) monitor for signs of bleeding.
Serotonergic drugs, including selective serotonin reuptake inhibitors (SSRIs e.g. paroxetine) and serotonin noradrenaline reuptake inhibitors (SNRIs e.g. venlafaxine) Increased risk of serotonin syndrome with concurrent use of 5-HT3 receptor antagonists (e.g. palonosetron, ondansetron, granisetron, tropisetron, dolasetron, etc.) Avoid combination.
If combination is clinically warranted, monitor for signs and symptoms of serotonin syndrome (e.g. confusion, agitation, tachycardia, hyperreflexia).
For more information link to TGA Medicines Safety Update opens in a new tab or window

eviQ provides safe and effective instructions on how to administer cancer treatments. However, eviQ does not provide every treatment delivery option, and is unable to provide a comprehensive list of cancer treatment agents and their required IV line giving set/filter or address chemical compatibilities related to IV drug preparation and administration. There may be alternative methods of treatment administration, and alternative supportive treatments that are also appropriate. Please refer to the individual product information monographs via the TGA opens in a new tab or window and Australian Injectable Drugs Handbook opens in a new tab or window websites for further information.

eviQ is currently updating the way information is presented in the administration section, if you notice any discrepancies please let us know, via feedback@eviq.org.au.

Day 1

Approximate treatment time: 6 hours

Pre treatment assessment

Anti-cancer drug patient assessment tool prior to each day of treatment.

Weigh patient.

Dipstick urinalysis to check for haematuria.

The administration of mesna will cause a false positive for ketonuria.

Pre treatment medication

Verify antiemetics taken or administer as prescribed.

Prior to administration

Prime IV line(s).

Insert IV cannula or access TIVAD or CVAD.

Prehydration

Administer 1000 mL sodium chloride 0.9% via IV infusion over 2 hours.

Mesna

Mesna is to commence 60 minutes before the first dose of cyclophosphamide.

Hyperhydration can be given in place of mesna as per local guidelines.rr Please see the haemorrhagic cystitis document for more information. 

Administer mesna:
  • via IV infusion over 5 hours.

Cyclophosphamide

Administer cyclophosphamide: 
  • via IV infusion over 60 minutes
  • flush with ~ 50 mL of sodium chloride 0.9%.
Potential adverse events:
  • rapid infusion can cause dizziness, rhinitis, nausea and perioral numbness, if symptoms develop slow infusion rate.

Post hydration

Administer 1000 mL sodium chloride 0.9% via IV infusion over 3 hours.

Post administration

Remove IV cannula and/or deaccess TIVAD or CVAD. 

Continue safe handling precautions until 7 days after completion of drug(s).

Day 3

Subcutaneous injection

Filgrastim

Administer filgrastim:
  • via subcutaneous injection TWICE daily, in divided doses (morning and evening), and continue until CD34+ stem cell collection target is reached.

The person/s responsible for monitoring the CD34+ counts are responsible for notifying the patient and all other appropriate healthcare professionals when stem cell collection is anticipated. Arrangements regarding leukopheresis are usually made by the BMT Coordinator or designated nurse.

Discharge information

Discharge medications

Growth factor support and arrangements for administration and detailed instructions of when to present for blood tests/monitoring.

Antiemetics - as/if prescribed.

Patient information

Ensure patient receives protocol patient information sheet.

The side effects listed below are not a complete list of all possible side effects for this treatment. Side effects are categorised into the approximate onset of presentation and should only be used as a guide.

Immediate (onset hours to days)
Bone pain

Bone pain, usually in the lower back or pelvis, associated with G-CSF.
Haemorrhagic cystitis

An inflammatory process, characterised by diffuse bladder mucosal inflammation resulting in haemorrhage. Patients are at risk following blood and marrow transplant (BMT) or treatment with cyclophosphamide, ifosfamide and/or radiation therapy.

Read more about haemorrhagic cystitis
Nausea and vomiting

Read more about prevention of treatment induced nausea and vomiting
Taste and smell alteration

Read more about taste and smell changes

Early (onset days to weeks)
Neutropenia

Abnormally low levels of neutrophils in the blood. This increases the risk of infection. Any fever or suspicion of infection should be investigated immediately and managed aggressively. 

Read more about immediate management of neutropenic fever
Thrombocytopenia

A reduction in the normal levels of functional platelets, increasing the risk of abnormal bleeding.  

Read more about thrombocytopenia
Diarrhoea

Read more about treatment induced diarrhoea
Fatigue

Read more about fatigue
Fluid retention and oedema

An excess amount of fluid around the cells, tissues or serous cavities of the body, leading to swelling.
Nephrotoxicity

Kidney dysfunction resulting from damage to the glomeruli, tubules or renal vasculature.
Oesophagitis

Inflammation of the mucosal lining of the oesophagus.  It can progress to ulceration, haemorrhage, secondary infection and pain.
Oral mucositis and stomatitis

Erythematous and ulcerative lesions of the gastrointestinal tract (GIT). It commonly develops following anti-cancer treatment, radiation therapy to the head, neck or oesophagus, and high-dose chemotherapy followed by a blood and marrow transplant (BMT).

Read more about oral mucositis and stomatitis
Skin rash

Anti-cancer drugs can cause a number of changes in the skin with maculo-papular rash the most common type of drug-induced skin reaction. 

Read more about skin rash

Late (onset weeks to months)
Anaemia

Abnormally low levels of red blood cells (RBCs) or haemoglobin in the blood. 

Read more about anaemia
Alopecia

Hair loss may occur from all parts of the body. Patients can also experience mild to moderate discomfort of the hair follicles, and rarely pain as the hair is falling out.

Read more about alopecia and scalp cooling
Cognitive changes (chemo fog)

Changes in cognition characterised by memory loss, forgetfulness and feeling vague. This is also referred to as 'chemo brain' or 'chemo fog'.

Read more about cognitive changes (chemo fog) 

Delayed (onset months to years)
Pulmonary toxicity

Pulmonary toxicity may include damage to the lungs, airways, pleura and pulmonary circulation. 

Read more about pulmonary toxicity associated with anti-cancer drugs

eviQ is currently updating the way information is presented in the evidence section to improve usability, consistency and facilitate easier update and maintenance. An updated evidence template is being implemented in a staged approach, first across new protocols, then existing protocols as they are reviewed. Find out more

Autologous stem cell transplant (ASCT) is only possible where sufficient numbers of CD34+ stem cells are available for re-infusion following high-dose therapy. As a consequence, it is important to establish both those factors that predict successful stem cell mobilisation and the optimal regimen for stem cell mobilisation.

A number of factors have been shown to influence mobilisation and stem cell collection including:

  • the number of cycles of prior chemotherapy
  • the number of prior chemotherapy regimens
  • pelvic radiation therapy
  • exposure to chemotherapeutic agents that are ‘stem cell toxic’ e.g. melphalan, carmustine
  • lenalidomide, although current evidence suggests the effect of prolonged lenalidomide exposure on successful harvest is less than previously thought, and the majority of individuals can be collected with the addition of plerixaforrr
  • age (decreasing yield with advancing age)
  • platelet count at the time of apheresis (platelet count greater than 200 x 109/L is associated with successful mobilisation).rrrrr

The expert reference panel supported publication of this protocol on the basis of the information summarised in the tables below. The committee was most strongly influenced by a number of studies, including meta-analyses, that demonstrate superiority of cyclophosphamide (CY) + granulocyte colony-stimulating factor (G-CSF) versus G-CSF alone regarding the number of CD34+ stem cells mobilised and the number of apheresis procedures required. Like mobilisation using G-CSF, the CY/G-CSF regimen also allows predictable mobilisation (10-14 days post treatment).rrrrrrrrr

Whilst the use of CY facilitates increased stem cell collection and reduces the risk of collection failure, it does prolong the collection process and increase the risk of infectious complications including febrile neutropenia. There is no evidence of cyclophosphamide impacting the overall transplant outcome, irrespective of dose. Utilisation of additional chemotherapeutic does not appear to be superior to CY aloner. There is a suggestion in the era of novel agent induction that the use of CY vs G-CSF alone may impair engraftment, but further confirmatory studies are needed.rr

Evidence for cyclophosphamide dosage

A number of studies have compared the effectiveness (measured in terms of the likelihood of achieving sufficient CD34+ stem cells for a single or tandem ASCT) and toxicity of high-dose (7 g/m2), intermediate-dose (3 to 4 g/m2) and low-dose (1.2 to 2 g/m2) cyclophosphamide.rrrr

The results of these studies suggest that intermediate-dose (3 to 4 g/m2) cyclophosphamide is as effective as high-dose (7 g/m2) cyclophosphamide but is associated with less clinical toxicity.rrr While lower doses of cyclophosphamide (1.2 to 2 g/m2) may be associated with less toxicity and fewer episodes of febrile neutropenia, data regarding the efficacy of stem cell mobilisation with lower doses of cyclophosphamide is less clear, with some studies suggesting equivalent effectiveness in mobilisation, while a number of studies suggest that lower doses of cyclophosphamide may yield lower numbers of CD34+ stem cells and require more apheresis procedures. The expert committee agrees that any intermediate dose of CY is appropriate (e.g. 3-4 g/m2) and that lower doses may be more appropriate in certain populationrrrr

Evidence level (NHMRC) Study
(Author/ref nos.)		 Study design Disease Is the mobilisation regimen* consistent with the protocol? Comments
I Luo et al.r Meta-analysis MM and NHL Variable doses utilised  
III-2 Hiwase et al.r Retrospective cohort MM CY 3-4 g/m2 + G-CSF Compared vs CY 1-2 g/m2
III-2 Hamadani et al.r Retrospective cohort MM CY 3-4 g/m2 + G-CSF Compared vs CY 1.5 g/m2
III-2 Alegre et al.r Retrospective cohort MM CY 4 g/m2 + G-CSF Compared vs G-CSF alone
III-2 Jantunen et al.r Retrospective cohort MM CY 4 g/m2 + G-CSF Compared vs CY 1.2-2 g/m2
III-2 Gojo et al.r Prospective, non-randomised MM CY 4.5 g/m2 + G-CSF Compared vs CY + etoposide
III-1 Silvennoinen et al.r Prospective, randomised MM CY 2 g/m2 + G-CSF Compared vs G-CSF alone
III-2 Fitoussi et al.r Retrospective cohort MM CY 4 g/m2 + G-CSF/GM-CSF Compared vs CY 7 g/m2
III-1 Narayanasami et al.r Prospective, randomised NHL and HL CY 5 g/m2 + G-CSF Compared vs G-CSF alone

* Chemotherapy ONLY; MM - multiple myeloma; NHL - non-Hodgkin lymphoma; HL - Hodgkin lymphoma

Efficacy

Study No. of patients Median CD34+ cell yield (x106kg) Median no. of apheresis % pts obtaining sufficient CD34+ for ASCT % pts proceeding to ASCT Median days to neutrophil engraftment Median days to platelet engraftment

No. pts graft failure
Hiwase et al.r CY 3-4 g/m2 26 7.71 1 92 92 16 24 0
CY 1-2 g/m2  61 5.17 1 89 85 14 19 0
Hamadani et al.r CY 3-4 g/m2 55 16 (day 1) 2.2 100 100 10 17 0
CY 1.5 g/m2 68 4 (day 1) 2.5 94 100 14 18 0
Alegre et al.r CY 4 g/m2 18 6.8 5 100 NR 12 11 0
Jantunen et al.r CY 4 g/m2 32 4.8 NR (84% achieved 2x106/kg after 1 apheresis) 100 100 11 11.5 0
Gojo et al.r CY 4.5 g/m2 28 21.38 1 86 100 11.5 14 0
Silvennoinen et al.r CY 2 g/m2 34 6.7 1 94 NR 14 12 0
Fitoussi et al.r CY 4 g/m2 42 13.4 3 93 NR NR NR NR
Narayanasami et al.r CY 5 g/m2 24 7.2 1 96 100 11 13 0

ASCT - autologous stem cell transplant; CY - cyclophosphamide; NR - not reported

Toxicity

Study % febrile neutropenia % anaemia requiring RBC transfusion/therapy* % thrombocytopenia requiring platelet transfusion* % infection*
Hiwase et al.r CY 3-4 g/m2 13 19 3 38
CY 1-2 g/m2  8 11 1.6 13
Hamadani et al.r CY 3-4 g/m2 16.3 34.5 21.8 16.3
CY 1.5 g/m2 5.8 8.8 2.9 7.3
Alegre et al.r CY 4 g/m2 11 27.7 33.3 11
Jantunen et al.r CY 4 g/m2  72 53 34 72
Gojo et al.r CY 4.5 g/m2  25 NR NR 25
Silvennoinen et al.r CY 2 g/m2 90 (during ASCT) NR NR NR
Fitoussi et al.r CY 4 g/m2 16.7 52.4 26.2 16.7
Narayanasami et al.r CY 5 g/m2 NR NR NR NR

*Studies did not differentiate between numbers in mobilisation vs numbers in subsequent ASCT; RBC - red blood cell

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Version 7

Date Summary of changes
31/01/2024

Protocol assessed by eviQ BMT Reference Committee and deemed suitable to be reviewed as required. Flag added, review date removed and version number increased to V.7. Read more about as required review protocol status in this factsheet.

Version 6

Date Summary of changes
21/09/2020 Biosimilar drug added to clinical information. Version number changed to v.6
27/05/2022 Protocol title updated to reflect eviQ naming convention.
28/08/2022 Reviewed by the BMT Reference Committee. Protocol evidence section updated to align with BMT template. Review in 2 years.

Version 5

Date Summary of changes
16/04/2020 'Mesna dosing and administration' block added to clinical information. Version number changed to v.5
31/07/2020 Reviewed by BMT Reference Committee, no changes made. Review in 2 years.

Version 4

Date Summary of changes
17/11/2010 New protocol taken to BMT Reference Committee meeting.
18/02/2011 Approved and published on eviQ.
4/10/2011 New format to allow for export of protocol information.
Protocol version number changed to V.2.
Antiemetics and premedications added to the treatment schedule.
Additional clinical information, key prescribing table and key administration table combined into new section titled Clinical Considerations.
Drug specific information placed behind the drug name link.
29/04/2016

Protocol reviewed at the BMT Reference Committee meeting:

- note added re the dose range of cyclophosphamide
- evidence updated
31/05/2017

Transferred to new eviQ website.
10/10/2017 Dose (3 g/m2) removed from the title following discussion from September 2017 BMT Reference Committee meeting. 
11/05/2018 Protocol information updated to include the option of hyper-hydration with high dose cyclophosphamide. 

The information contained in this protocol is based on the highest level of available evidence and consensus of the eviQ reference committee regarding their views of currently accepted approaches to treatment. Any clinician (medical oncologist, haematologist, radiation oncologist, medical physicist, radiation therapist, pharmacist or nurse) seeking to apply or consult this protocol is expected to use independent clinical judgement in the context of individual clinical circumstances to determine any patient's care or treatment. While eviQ endeavours to link to reliable sources that provide accurate information, eviQ and the Cancer Institute NSW do not endorse or accept responsibility for the accuracy, currency, reliability or correctness of the content of linked external information sources. Use is subject to eviQ’s disclaimer available at www.eviQ.org.au

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Review due:
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The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/707

05 Jul 2025