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NCT02268253 · OUTCOME

Objective Response Rate (ORR)

Tagraxofusp (SL-401) in Participants With Chronic Myelomonocytic Leukemia (CMML) and Myelofibrosis (MF) · Source last updated 2025-01-06

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

Measure
NUMBER
Unit
participants
Interval / dispersion
95% Confidence Interval
Time frame
1145 days

What was measured

ORR was defined as the percentage of participants (responders) who achieved disease-specific complete response (CR) or partial response (PR) after treatment. For response assessment of myelofibrosis during both Stage 1 and Stage 2, the International Working Group-Myeloproliferative Neoplasms Research and Treatment and European LeukemiaNet (IWG-MRT/ELN 2013) criteria were used. For chronic myelomonocytic leukemia, during both Stage 1 and Stage 2, the International Working Group 2006 response criteria for myelodysplastic syndromes (IWG MDS 2006) were used for response assessment while the Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) 2015 criteria were used for response assessment during Stage 3A.

Analysis population: Modified Intent-to-Treat (mITT): Any participant who received at least 1 dose of study intervention and was evaluable for efficacy assessment. Presentation of reporting groups based upon shared criteria used for response assessment and prior treatment history (previously untreated \[treatment naive\]; previously treated \[relapsed/refractory\]). Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.

Groups in this outcome

Stages 1-2: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Myelofibrosis

Treatment-naive participants with myelofibrosis treated with tagraxofusp 12 µg/kg/day.

Stages 1-2: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Myelofibrosis

Relapsed/refractory participants with myelofibrosis treated with tagraxofusp 12 µg/kg/day.

Stages 1-2: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Chronic Myelomonocytic Leukemia

Treatment-naive participants with chronic myelomonocytic leukemia treated with tagraxofusp 12 µg/kg/day.

Stages 1-2: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Chronic Myelomonocytic Leukemia

Relapsed/refractory participants with chronic myelomonocytic leukemia treated with tagraxofusp 12 µg/kg/day.

Stage 3A: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Chronic Myelomonocytic Leukemia

Treatment-naive participants with chronic myelomonocytic leukemia treated with tagraxofusp 12 µg/kg/day

Stage 3A: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Chronic Myelomonocytic

Relapsed/refractory participants with chronic myelomonocytic leukemia treated with tagraxofusp 12 µg/kg/day.

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

Analysis denominator · Participants

GroupSource count
Stages 1-2: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Myelofibrosis5
Stages 1-2: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Myelofibrosis25
Stages 1-2: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Chronic Myelomonocytic Leukemia8
Stages 1-2: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Chronic Myelomonocytic Leukemia17
Stage 3A: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Chronic Myelomonocytic Leukemia7
Stage 3A: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Chronic Myelomonocytic5

Reported measurements

Source class 1
Values in participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Stages 1-2: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Myelofibrosis0Not reportedNANANot estimable due to no responders
Stages 1-2: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Myelofibrosis1Not reported0.120.4Not reported
Stages 1-2: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Chronic Myelomonocytic Leukemia0Not reportedNANANot estimable due to no responders
Stages 1-2: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Chronic Myelomonocytic Leukemia0Not reportedNANANot estimable due to no responders
Stage 3A: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Chronic Myelomonocytic Leukemia1Not reported0.457.9Not reported
Stage 3A: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Chronic Myelomonocytic0Not reportedNANANot estimable due to no responders
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Not estimable due to no responders
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      2. group Id
        OG001
        lower Limit
        0.1
        upper Limit
        20.4
        value
        1
      3. comment
        Not estimable due to no responders
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      4. comment
        Not estimable due to no responders
        group Id
        OG003
        lower Limit
        NA
        upper Limit
        NA
        value
        0
      5. group Id
        OG004
        lower Limit
        0.4
        upper Limit
        57.9
        value
        1
      6. comment
        Not estimable due to no responders
        group Id
        OG005
        lower Limit
        NA
        upper Limit
        NA
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      5
    2. group Id
      OG001
      value
      25
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      17
    5. group Id
      OG004
      value
      7
    6. group Id
      OG005
      value
      5
    units
    Participants
description
ORR was defined as the percentage of participants (responders) who achieved disease-specific complete response (CR) or partial response (PR) after treatment. For response assessment of myelofibrosis during both Stage 1 and Stage 2, the International Working Group-Myeloproliferative Neoplasms Research and Treatment and European LeukemiaNet (IWG-MRT/ELN 2013) criteria were used. For chronic myelomonocytic leukemia, during both Stage 1 and Stage 2, the International Working Group 2006 response criteria for myelodysplastic syndromes (IWG MDS 2006) were used for response assessment while the Myelodysplastic/Myeloproliferative Neoplasms (MDS/MPN) 2015 criteria were used for response assessment during Stage 3A.
dispersion Type
95% Confidence Interval
groups
  1. description
    Treatment-naive participants with myelofibrosis treated with tagraxofusp 12 µg/kg/day.
    id
    OG000
    title
    Stages 1-2: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Myelofibrosis
  2. description
    Relapsed/refractory participants with myelofibrosis treated with tagraxofusp 12 µg/kg/day.
    id
    OG001
    title
    Stages 1-2: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Myelofibrosis
  3. description
    Treatment-naive participants with chronic myelomonocytic leukemia treated with tagraxofusp 12 µg/kg/day.
    id
    OG002
    title
    Stages 1-2: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Chronic Myelomonocytic Leukemia
  4. description
    Relapsed/refractory participants with chronic myelomonocytic leukemia treated with tagraxofusp 12 µg/kg/day.
    id
    OG003
    title
    Stages 1-2: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Chronic Myelomonocytic Leukemia
  5. description
    Treatment-naive participants with chronic myelomonocytic leukemia treated with tagraxofusp 12 µg/kg/day
    id
    OG004
    title
    Stage 3A: Tagraxofusp 12 µg/kg/Day - Treatment Naive - Chronic Myelomonocytic Leukemia
  6. description
    Relapsed/refractory participants with chronic myelomonocytic leukemia treated with tagraxofusp 12 µg/kg/day.
    id
    OG005
    title
    Stage 3A: Tagraxofusp 12 µg/kg/Day - Relapsed/Refractory - Chronic Myelomonocytic
param Type
NUMBER
population Description
Modified Intent-to-Treat (mITT): Any participant who received at least 1 dose of study intervention and was evaluable for efficacy assessment. Presentation of reporting groups based upon shared criteria used for response assessment and prior treatment history (previously untreated \[treatment naive\]; previously treated \[relapsed/refractory\]). Here, 'Overall Number of Participants Analyzed' signifies those participants who were evaluable for this outcome measure.
reporting Status
POSTED
time Frame
1145 days
title
Objective Response Rate (ORR)
type
PRIMARY
unit Of Measure
participants

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice