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NCT04145531 · OUTCOME

Response Rate During the 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline up to 2 weeks

What was measured

The response rate was defined as the number (proportion) of patients with the last 72-hour nadir serum asparaginase activity (NSAA) level ≥ 0.1 IU/mL during the first course of IM JZP-458. Blood samples were collected for serum asparaginase activity level determination.

Analysis population: Response rates were assessed in the Efficacy Analysis Set in participants with available data.

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

GroupSource 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

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part A: JZP-458 IM 25 mg/m^2 (MWF)18Not reportedNot reportedNot reportedNot reported
Part A: JZP-458 IM 37.5 mg/m^2 (MWF)70Not reportedNot reportedNot reportedNot reported
Part A: JZP-458 IM 25 (MW)/50 mg/m^2 (F)44Not reportedNot reportedNot reportedNot reported
Part B: JZP-458 IV 25 (MW)/50 mg/m^2 (F)20Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        70
      3. group Id
        OG002
        value
        44
      4. group Id
        OG003
        value
        20
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      77
    3. group Id
      OG002
      value
      49
    4. group Id
      OG003
      value
      50
    units
    Participants
description
The response rate was defined as the number (proportion) of patients with the last 72-hour nadir serum asparaginase activity (NSAA) level ≥ 0.1 IU/mL during the first course of IM JZP-458. Blood samples were collected for serum asparaginase activity level determination.
groups
  1. 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)
  2. 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)
  3. 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)
  4. 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
COUNT_OF_PARTICIPANTS
population Description
Response rates were assessed in the Efficacy Analysis Set in participants with available data.
reporting Status
POSTED
time Frame
Baseline up to 2 weeks
title
Response Rate During the First Course of JZP-458 Administration
type
PRIMARY
unit Of Measure
Participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice