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Flag V7 3.15

This document provides treatment guidelines for a chemotherapy regimen containing fludarabine, cytarabine, and G-CSF for relapsed or refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) in patients who have had previous anthracycline exposure or are not suitable for anthracycline. The regimen consists of 5 daily doses of fludarabine and cytarabine given over 7 days, along with daily G-CSF support. Dose modifications are specified for renal or hepatic impairment. Main toxicities include myelosuppression, mucositis, and alopecia.

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64 views

Flag V7 3.15

This document provides treatment guidelines for a chemotherapy regimen containing fludarabine, cytarabine, and G-CSF for relapsed or refractory acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) in patients who have had previous anthracycline exposure or are not suitable for anthracycline. The regimen consists of 5 daily doses of fludarabine and cytarabine given over 7 days, along with daily G-CSF support. Dose modifications are specified for renal or hepatic impairment. Main toxicities include myelosuppression, mucositis, and alopecia.

Uploaded by

Gabriel
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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FLAG

For treatment of relapsed, refractory AML and ALL, and for high risk AML
For patients with previous anthracycline exposure or not considered suitable for an anthracycline
Drugs/Dosage/Administration:
Day
1 7,
then according to
clinical situation and
Consultant decision
26
(5 doses)
26
(5 doses)

28

Other drugs:

Drug
G-CSF (see
Comments)

Dose
Lenograstim
263mcg or
Filgrastim 300mcg

Fludarabine

30mg/m2
diluted in 0.9%
sodium chloride
2000mg/m2
in 500ml 0.9%
sodium chloride
(If age > 60, give
1000mg/m2)
One drop

Cytarabine

Corticosteroid eye
drops e.g. Maxidex

Route
s/c bolus

Frequency
Once daily

IV in 100 250ml 0.9%


Once daily
sodium chloride over 30
minutes
IV over 4 hours, starting Once daily
exactly 4 hours after start
of Fludarabine infusion
To each eye

Every 4 hours,
increasing to 2
hourly if eyes
become sore

For patients with potential for tumour lysis syndrome, ensure initiation of prophylactic
measures according to Alliance guidelines for management of TLS.
PCP prophylaxis - prescribe according to unit practice/protocol (generally until 6 months after
completion of treatment, or according to CD4 counts)
Posaconazole to be taken during each cycle of chemotherapy, only when neutrophils drop*
to < 0.5x109/L and until they are > 0.5x109/L.
*In

the first cycle of treatment, give prophylaxis from the start of the cycle regardless of the
initial neutrophil count.
Frequency:

1 - 2 cycles as specified above, with the second cycle given only if the following criteria are
met: 15% blasts in bone marrow after Cycle 1
not considered to have adverse genetic abnormalities
neutrophils > 1.0 x 109/L and platelets > 100 x 109/L

Main Toxicities:

myelosuppression;
alopecia;
mucositis;
conjunctivitis (cytarabine);
prolonged T cell immunosuppression (fludarabine);
encephalopathy (fludarabine); ovarian failure; infertility

Anti-emetics:

highly emetogenic on Days 2 - 6

Extravasation:

non-vesicants

Reason for Update: posaconazole tablets available; suspension dose


removed
Version: 7
Supersedes: Version 6
Prepared by: S Taylor

Approved by Chair of Alliance TSSG: Dr A Laurie


Date: 16.3.15
Review date: April 2017
Checked by: C Tucker

Page 1 of 2

Regular
Investigations:

FBC

alternate days until neutropenia or thrombocytopenia occur,


then daily to recovery
Day 1, then three times weekly
Day 1, then once weekly
Day 1
baseline
if serum creatinine > 150mol/L

U&Es
LFTs
Mg2+ & Ca2+
Uric acid
Cr51-EDTA/24 hour urine
Comments:

Sperm banking if appropriate and time allows.


It is important that patient receives G-CSF one day before starting chemotherapy.
All patients must receive irradiated blood products for all future transfusions - inform patient
and blood bank.

Dose Modifications
Haematological
Toxicity:

Cycle 1:
Cycle 2:

There are no modifications for myelosuppression


Proceed once neutrophils > 1.0 x 109/L and platelets > 100 x 109/L

If low counts are thought to be due to marrow infiltration, discuss with Consultant.
Renal Impairment:
CrCl (ml/min)
> 70
30 70
< 30

Fludarabine Dose
Give 100% dose
Give 50% dose
Contra-indicated

Bilirubin (mol/L)
> 34

Cytarabine Dose
Give 50% dose

Hepatic Impairment:

Patient Information:

Macmillan leaflets for Cytarabine and Fludarabine

References:

Estey, E at al; JCO (1994); 671 678


AML 15 trial, MRC 2004
AML 17 trial, V5 May 2010

Reason for Update: posaconazole tablets available; suspension dose


removed
Version: 7
Supersedes: Version 6
Prepared by: S Taylor

Approved by Chair of Alliance TSSG: Dr A Laurie


Date: 16.3.15
Review date: April 2017
Checked by: C Tucker

Page 2 of 2

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