Profile of nelarabine: use in the treatment of T-cell acute lymphoblastic leukemia

Figures & data

Table 1 Pharmacokinetic parameter values (mean ± SD) for nelarabine, ara-G, ara-GTP^5,8,14

	Pediatric	Adult
Nelarabine
Vd (L)	8.511 ± 11.518	4.197 ± 5.802	NSa
CL (L/kg/h)	9.259 ± 12.794	5.875 ± 8.434	NSa
t½ (minutes)	14.1b	16.5b	NSa
ara-G
Vd (L)	1.023 ± 0.345	0.923 ± 0.231	NSa
CL (L/kg/h)	0.312 ± 0.112	0.213 ± 0.072	P < 0.0001
t½ (h)	2.1b	3.0b	P < 0.01
ara-GTP
Mean ara-GTP (μM)		435 ± 519
		746 ± 872c
t½ (h)	>24b,d

a No statistical difference.

b Harmonic mean value.

c Nelarabine following fludarabine (combination).

d Patient with T-cell disease.

Abbreviations: CL, clearance; Vd, volume of distribution.

Table 2 Neurologic adverse events in pediatric patients treated with nelarabine 650 mg/m² intravenously for 5 consecutive days, repeated every 21 days²¹

Nervous system disorders	Patient population (n = 84)
	Grade 3/4 (%)	All Grades (%)
Headache	6	17
Peripheral neurologic disorders	7	12
Lowered consciousness	2	7
Peripheral neurologic disorders	7	12
Hypoesthesia	4	6
Seizures	6	6
Motor dysfunction	1	4
Nervous system disorder	0	4
Paresthesia	1	4
Tremor	0	4
Ataxia	1	2

Table 3 Neurologic adverse events in adult patients treated with nelarabine 1500 mg/m² intravenously over 2 hours on days 1, 3, and 5 repeated every 21 days²¹

Nervous system disorders	Patient population (n = 103)
	Grade 3/4 (%)	All Grades (%)
Lowered consciousness	14	63
Dizziness	0	21
Peripheral neurologic disorders	2	18
Hypoesthesia	2	17
Headache	1	15
Paresthesia	0	15
Ataxia	2	9
Tremor	0	5
Neuropathy	0	4
Amnesia	0	3
Dysguesia	0	3
Balance disorder	0	2
Sensory loss	0	2
Seizures	1	1

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