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NCT02303821 · OUTCOME

Phase 2: Cmax 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
ng/mL
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

Cmax is the maximum concentration of a drug in the bloodstream after administration.

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 Cycle83
Carfilzomib - Day 1 Consolidation Cycle34

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Carfilzomib - Day 8 Induction Cycle959027800Not reportedNot reportedNot reported
Carfilzomib - Day 1 Consolidation Cycle1380044200Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        27800
        value
        9590
      2. group Id
        OG001
        spread
        44200
        value
        13800
denoms
  1. counts
    1. group Id
      OG000
      value
      83
    2. group Id
      OG001
      value
      34
    units
    Participants
description
Cmax is the maximum concentration of a drug in the bloodstream after administration.
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: Cmax of Carfilzomib
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice