Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02303821 · OUTCOME

Phase 2: Terminal Half-life (t1/2,z) of Carfilzomib

Study of Carfilzomib in Combination With Induction Chemotherapy in Children With Relapsed or Refractory Acute Lymphoblastic Leukemia · Source last updated 2025-06-04

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

Measure
MEAN
Unit
hour
Interval / dispersion
Standard Deviation
Time frame
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)

What was measured

T1/2,z refers to the time required for the plasma concentration of a drug to decrease by half during the final phase of elimination from the body.

Analysis population: Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell.

Groups in this outcome

Carfilzomib - Day 8 Induction Cycle

Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 8 of the induction cycle.

Carfilzomib - Day 1 Consolidation Cycle

Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 1 of the consolidation cycle.

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

Analysis denominator · Participants

GroupSource count
Carfilzomib - Day 8 Induction Cycle46
Carfilzomib - Day 1 Consolidation Cycle23

Reported measurements

Source class 1
Values in hour · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib - Day 8 Induction Cycle0.3710.162Not reportedNot reportedNot reported
Carfilzomib - Day 1 Consolidation Cycle0.3320.0894Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.162
        value
        0.371
      2. group Id
        OG001
        spread
        0.0894
        value
        0.332
denoms
  1. counts
    1. group Id
      OG000
      value
      46
    2. group Id
      OG001
      value
      23
    units
    Participants
description
T1/2,z refers to the time required for the plasma concentration of a drug to decrease by half during the final phase of elimination from the body.
dispersion Type
Standard Deviation
groups
  1. description
    Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 8 of the induction cycle.
    id
    OG000
    title
    Carfilzomib - Day 8 Induction Cycle
  2. description
    Eligible participants with relapsed or refractory acute lymphoblastic leukemia who had PK assessments on Day 1 of the consolidation cycle.
    id
    OG001
    title
    Carfilzomib - Day 1 Consolidation Cycle
param Type
MEAN
population Description
Phase 2 PK analysis set: All participants who received at least 1 dose of carfilzomib, had 1 PK sample collected and a quantifiable number of observations. Per SAP, analysis was not planned to compare T-cell and B-cell.
reporting Status
POSTED
time Frame
Day 8 of induction cycle (28-days cycle) and Day 1 of consolidation cycle (28-days cycle)
title
Phase 2: Terminal Half-life (t1/2,z) of Carfilzomib
type
SECONDARY
unit Of Measure
hour

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

Preserved source evidence · Not medical advice