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NCT05038800 · OUTCOME

Composite CR Rate

A Study to Evaluate MK-0482 for Relapsed/Refractory Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia (CMML) (MK-0482-002) · Source last updated 2025-05-21

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 10 months

What was measured

Composite CR rate was assessed by the investigator per 2017 ELN Response Criteria for AML and was defined as CR plus CR with incomplete recovery (CRi). CR was defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10\^9/L (1000/µL); and platelet count ≥100 × 10\^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (\<1.0 × 10\^9/L \[1000/µL\]) or thrombocytopenia (\<100 × 10\^9/L \[100,000/µL\]). The percentage of participants with Composite CR (Composite CR Rate) was reported for each arm.

Analysis population: All allocated participants who received at least 1 dose of study intervention and had a baseline assessment were analyzed.

Groups in this outcome

MK-0482 7.5 mg Q3W

Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for up to 35 cycles (approximately 24 months).

MK-0482 25 mg Q3W

Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

MK-0482 75 mg Q3W

Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

MK-0482 225 mg Q3W

Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

MK-0482 750 mg Q3W

Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).

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

Analysis denominator · Participants

GroupSource count
MK-0482 7.5 mg Q3W1
MK-0482 25 mg Q3W1
MK-0482 75 mg Q3W5
MK-0482 225 mg Q3W3
MK-0482 750 mg Q3W1

Reported measurements

Source class 1
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
MK-0482 7.5 mg Q3W0.0Not reported0.097.5Not reported
MK-0482 25 mg Q3W0.0Not reported0.097.5Not reported
MK-0482 75 mg Q3W0.0Not reported0.052.2Not reported
MK-0482 225 mg Q3W0.0Not reported0.070.8Not reported
MK-0482 750 mg Q3W0.0Not reported0.097.5Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        97.5
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        97.5
        value
        0.0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        52.2
        value
        0.0
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        70.8
        value
        0.0
      5. group Id
        OG004
        lower Limit
        0.0
        upper Limit
        97.5
        value
        0.0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      1
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      1
    units
    Participants
description
Composite CR rate was assessed by the investigator per 2017 ELN Response Criteria for AML and was defined as CR plus CR with incomplete recovery (CRi). CR was defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC ≥1.0 × 10\^9/L (1000/µL); and platelet count ≥100 × 10\^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (\<1.0 × 10\^9/L \[1000/µL\]) or thrombocytopenia (\<100 × 10\^9/L \[100,000/µL\]). The percentage of participants with Composite CR (Composite CR Rate) was reported for each arm.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were to receive 7.5 mg of MK-0482 via intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks \[Q3W\]) for up to 35 cycles (approximately 24 months).
    id
    OG000
    title
    MK-0482 7.5 mg Q3W
  2. description
    Participants were to receive 25 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG001
    title
    MK-0482 25 mg Q3W
  3. description
    Participants were to receive 75 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG002
    title
    MK-0482 75 mg Q3W
  4. description
    Participants were to receive 225 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG003
    title
    MK-0482 225 mg Q3W
  5. description
    Participants were to receive 750 mg of MK-0482 via IV infusion on Day 1 of each 21-day cycle (Q3W) for up to 35 cycles (approximately 24 months).
    id
    OG004
    title
    MK-0482 750 mg Q3W
param Type
NUMBER
population Description
All allocated participants who received at least 1 dose of study intervention and had a baseline assessment were analyzed.
reporting Status
POSTED
time Frame
Up to approximately 10 months
title
Composite CR Rate
type
SECONDARY
unit Of Measure
Percentage of Participants

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Preserved source evidence · Not medical advice