NCT04145531 · OUTCOME

Mean Serum Asparaginase Activity Levels in First Course of JZP-458 Administration

An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) · Source last updated 2023-11-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: IU/mL
Interval / dispersion: 95% Confidence Interval
Time frame: Up to 2 weeks (6 doses)

What was measured

Serum asparaginase levels serve as a surrogate marker for asparagine depletion. Mean serum asparaginase activity levels in Course 1 are reported.

Analysis population: Serum asparaginase activity levels were assessed in participants with available data in the Efficacy Analysis Set.

Groups in this outcome

Part A: JZP-458 IM 25 mg/m^2 (MWF)

Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.

Part A: JZP-458 IM 37.5 mg/m^2 (MWF)

Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.

Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)

Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.

Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)

Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Part A: JZP-458 IM 25 mg/m^2 (MWF)	32
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)	83
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)	49
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)	59

Reported measurements

Last 48 hours

Analysis denominator · Participants

Group	Source count
Part A: JZP-458 IM 25 mg/m^2 (MWF)	32
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)	83
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)	49
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)	59

Values in IU/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Part A: JZP-458 IM 25 mg/m^2 (MWF)	0.45	Not reported	0.37	0.53	Not reported
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)	0.88	Not reported	0.76	1.01	Not reported
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)	0.66	Not reported	0.54	0.77	Not reported
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)	0.25	Not reported	0.20	0.29	Not reported

Last 72 hours

Analysis denominator · Participants

Group	Source count
Part A: JZP-458 IM 25 mg/m^2 (MWF)	28
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)	77
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)	49
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)	50

Values in IU/mL · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Part A: JZP-458 IM 25 mg/m^2 (MWF)	0.16	Not reported	0.12	0.19	Not reported
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)	0.33	Not reported	0.28	0.39	Not reported
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)	0.47	Not reported	0.35	0.59	Not reported
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)	0.10	Not reported	0.07	0.13	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.37
upper Limit
0.53
value
0.45
group Id
OG001
lower Limit
0.76
upper Limit
1.01
value
0.88
group Id
OG002
lower Limit
0.54
upper Limit
0.77
value
0.66
group Id
OG003
lower Limit
0.20
upper Limit
0.29
value
0.25
denoms
counts
group Id
OG000
value
32
group Id
OG001
value
83
group Id
OG002
value
49
group Id
OG003
value
59
units
Participants
title
Last 48 hours
categories
measurements
group Id
OG000
lower Limit
0.12
upper Limit
0.19
value
0.16
group Id
OG001
lower Limit
0.28
upper Limit
0.39
value
0.33
group Id
OG002
lower Limit
0.35
upper Limit
0.59
value
0.47
group Id
OG003
lower Limit
0.07
upper Limit
0.13
value
0.10
denoms
counts
group Id
OG000
value
28
group Id
OG001
value
77
group Id
OG002
value
49
group Id
OG003
value
50
units
Participants
title
Last 72 hours

denoms

counts
group Id
OG000
value
32
group Id
OG001
value
83
group Id
OG002
value
49
group Id
OG003
value
59
units
Participants

description

Serum asparaginase levels serve as a surrogate marker for asparagine depletion. Mean serum asparaginase activity levels in Course 1 are reported.

dispersion Type

95% Confidence Interval

groups

description
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks based on available data from the Phase 1 (JZP458-101) healthy volunteer study.
id
OG000
title
Part A: JZP-458 IM 25 mg/m^2 (MWF)
description
Participants who received an intramuscular (IM) dose of JZP-458 37.5 mg/m\^2 on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
id
OG001
title
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)
description
Participants who received an intramuscular (IM) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
id
OG002
title
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)
description
Participants who received an intravenous (IV) dose of JZP-458 25 mg/m\^2 on Mondays and Wednesdays and 50 mg/m\^2 on Fridays on a Monday/Wednesday/Friday (MWF) schedule over 2 weeks.
id
OG003
title
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)

param Type

MEAN

population Description

Serum asparaginase activity levels were assessed in participants with available data in the Efficacy Analysis Set.

reporting Status

POSTED

time Frame

Up to 2 weeks (6 doses)

title

Mean Serum Asparaginase Activity Levels in First Course of JZP-458 Administration

type

SECONDARY

unit Of Measure

IU/mL

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Preserved source evidence · Not medical advice