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NCT02303821 · OUTCOME

Phase 1b: Percentage of Participants Who Achieved a Combined CR and CR Without Platelet Recovery (CRp) at the End of Induction Cycle

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
NUMBER
Unit
Percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day 29)

What was measured

CR was defined as the attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC \> 750 mcl and platelet count \> 75,000 mcl). CRp was defined as the attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease and with recovery of ANCs (ANC \> 750 mcl), but with insufficient recovery of platelets (\< 75,000 mcl).

Analysis population: Phase 1b Induction SAS: All participants who received any amount of the study treatment regimen during the induction period and had available data.

Groups in this outcome

Phase 1b: Dose Escalation 1 (20 mg/m^2)

Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).

Phase 1b: Dose Escalation 1 (20/27 mg/m^2)

Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).

Phase 1b: Dose Escalation 2 (20/27 mg/m^2)

Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).

Phase 1b: Dose Escalation 2 (20/36 mg/m^2)

Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).

Phase 1b: Dose Escalation 2 (20/45 mg/m^2)

Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).

Phase 1b: Dose Escalation 2 (20/56 mg/m^2)

Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional 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
Phase 1b: Dose Escalation 1 (20 mg/m^2)5
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)5
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)3
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)7
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)4
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)10

Reported measurements

Source class 1
Values in Percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1b: Dose Escalation 1 (20 mg/m^2)40.0Not reported5.385.3Not reported
Phase 1b: Dose Escalation 1 (20/27 mg/m^2)20.0Not reported0.571.6Not reported
Phase 1b: Dose Escalation 2 (20/27 mg/m^2)33.3Not reported0.890.6Not reported
Phase 1b: Dose Escalation 2 (20/36 mg/m^2)28.6Not reported3.771.0Not reported
Phase 1b: Dose Escalation 2 (20/45 mg/m^2)25.0Not reported0.680.6Not reported
Phase 1b: Dose Escalation 2 (20/56 mg/m^2)20.0Not reported2.555.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.3
        upper Limit
        85.3
        value
        40.0
      2. group Id
        OG001
        lower Limit
        0.5
        upper Limit
        71.6
        value
        20.0
      3. group Id
        OG002
        lower Limit
        0.8
        upper Limit
        90.6
        value
        33.3
      4. group Id
        OG003
        lower Limit
        3.7
        upper Limit
        71.0
        value
        28.6
      5. group Id
        OG004
        lower Limit
        0.6
        upper Limit
        80.6
        value
        25.0
      6. group Id
        OG005
        lower Limit
        2.5
        upper Limit
        55.6
        value
        20.0
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      7
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      10
    units
    Participants
description
CR was defined as the attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease and with recovery of peripheral counts (ANC \> 750 mcl and platelet count \> 75,000 mcl). CRp was defined as the attainment of M1 bone marrow status with no evidence of circulating blasts or extramedullary disease and with recovery of ANCs (ANC \> 750 mcl), but with insufficient recovery of platelets (\< 75,000 mcl).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
    id
    OG000
    title
    Phase 1b: Dose Escalation 1 (20 mg/m^2)
  2. description
    Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with R3 IV for approximately 9 weeks (1-week lead-in window, 28-day induction cycle, and 28-day optional consolidation cycle).
    id
    OG001
    title
    Phase 1b: Dose Escalation 1 (20/27 mg/m^2)
  3. description
    Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 27 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
    id
    OG002
    title
    Phase 1b: Dose Escalation 2 (20/27 mg/m^2)
  4. description
    Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 36 mg/m\^2 dose in combination with VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
    id
    OG003
    title
    Phase 1b: Dose Escalation 2 (20/36 mg/m^2)
  5. description
    Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 45 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
    id
    OG004
    title
    Phase 1b: Dose Escalation 2 (20/45 mg/m^2)
  6. description
    Participants with relapsed or refractory ALL received carfilzomib 20 mg/m\^2 for the first dose, followed by the target 56 mg/m\^2 dose in combination VXLD IV for approximately 8 weeks (28-day induction cycle, and 28-day optional consolidation cycle).
    id
    OG005
    title
    Phase 1b: Dose Escalation 2 (20/56 mg/m^2)
param Type
NUMBER
population Description
Phase 1b Induction SAS: All participants who received any amount of the study treatment regimen during the induction period and had available data.
reporting Status
POSTED
time Frame
Up to approximately Day 29 of Induction Cycle (28-days cycle, assessment on Day 29)
title
Phase 1b: Percentage of Participants Who Achieved a Combined CR and CR Without Platelet Recovery (CRp) at the End of Induction Cycle
type
SECONDARY
unit Of Measure
Percentage of participants

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Preserved source evidence · Not medical advice