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NCT00261846 · OUTCOME

Duration of Complete Hematologic Response (CHR) - Part 2

Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias · Source last updated 2017-07-27

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

Measure
MEDIAN
Unit
weeks
Interval / dispersion
95% Confidence Interval
Time frame
From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)

What was measured

Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes less than (\<)5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10\^9 per liter (/L) , platelets \<450×10\^9/L, platelets ≥100×10\^9/L, \<20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7. NA = not estimable.

Analysis population: Subgroup of participants from evaluable population who had confirmed CHR.

Groups in this outcome

Bosutinib 500 mg, CP2L-CML IM-R (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.

Bosutinib 500 mg, CP2L-CML IM-I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.

Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.

Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.

Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.

Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.

Bosutinib 500 mg, AP-CML IM R/I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.

Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.

Bosutinib 500 mg, BP-CML IM R/I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.

Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.

Bosutinib 500 mg, Ph+ ALL (Part 2)

Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL

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

Analysis denominator · Participants

GroupSource count
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)169
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)76
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)4
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)26
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)37
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)19
Bosutinib 500 mg, AP-CML IM R/I (Part 2)17
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)7
Bosutinib 500 mg, BP-CML IM R/I (Part 2)9
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)1
Bosutinib 500 mg, Ph+ ALL (Part 2)2

Reported measurements

Source class 1
Values in weeks · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Bosutinib 500 mg, CP2L-CML IM-R (Part 2)NANot reported297.7NAKM estimate at Year 5 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, CP2L-CML IM-I (Part 2)350.4Not reported350.4NAThe upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)NANot reported9.6NAKM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)NANot reported38.3NAKM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)295.6Not reported289.0NAThe upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)NANot reported56.0NAKM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, AP-CML IM R/I (Part 2)138.0Not reported24.0NAThe upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)NANot reported102.0NAKM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, BP-CML IM R/I (Part 2)28.6Not reported20.1NAThe upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)40.0Not reportedNANA95% CIs were NA due to insufficient patients and/or follow-up.
Bosutinib 500 mg, Ph+ ALL (Part 2)NANot reportedNANAKM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        KM estimate at Year 5 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG000
        lower Limit
        297.7
        upper Limit
        NA
        value
        NA
      2. comment
        The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG001
        lower Limit
        350.4
        upper Limit
        NA
        value
        350.4
      3. comment
        KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG002
        lower Limit
        9.6
        upper Limit
        NA
        value
        NA
      4. comment
        KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG003
        lower Limit
        38.3
        upper Limit
        NA
        value
        NA
      5. comment
        The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG004
        lower Limit
        289.0
        upper Limit
        NA
        value
        295.6
      6. comment
        KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG005
        lower Limit
        56.0
        upper Limit
        NA
        value
        NA
      7. comment
        The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG006
        lower Limit
        24.0
        upper Limit
        NA
        value
        138.0
      8. comment
        KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG007
        lower Limit
        102.0
        upper Limit
        NA
        value
        NA
      9. comment
        The upper limit of 95% CI was NA due to insufficient patients and/or follow-up.
        group Id
        OG008
        lower Limit
        20.1
        upper Limit
        NA
        value
        28.6
      10. comment
        95% CIs were NA due to insufficient patients and/or follow-up.
        group Id
        OG009
        lower Limit
        NA
        upper Limit
        NA
        value
        40.0
      11. comment
        KM estimate at Year 4 was NA due to insufficient patients and/or follow-up. 95% CIs were NA due to insufficient patients and/or follow-up.
        group Id
        OG010
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      169
    2. group Id
      OG001
      value
      76
    3. group Id
      OG002
      value
      4
    4. group Id
      OG003
      value
      26
    5. group Id
      OG004
      value
      37
    6. group Id
      OG005
      value
      19
    7. group Id
      OG006
      value
      17
    8. group Id
      OG007
      value
      7
    9. group Id
      OG008
      value
      9
    10. group Id
      OG009
      value
      1
    11. group Id
      OG010
      value
      2
    units
    Participants
description
Hematologic response: if participants met all of the following criteria of CHR: White Blood Cells equal to or less than (≤) institutional upper limit of normal, no peripheral blood blasts or promyelocytes, myelocytes+metamyelocytes less than (\<)5% in blood, absolute neutrophil count greater than or equal to (≥) 1.0×10\^9 per liter (/L) , platelets \<450×10\^9/L, platelets ≥100×10\^9/L, \<20% basophils in blood and no extramedually involvement (including hepato- or splenomegaly), ≤5% BM blasts (required for ADV only and applicable to CP if BM aspirate was performed). The duration of CHR was defined as the interval from the first date of response until the first date of confirmed loss of response. Duration of response in weeks =(date of confirmed loss of attained response or last valid hematologic assessment for those censored - date of first confirmed response)/7. NA = not estimable.
dispersion Type
95% Confidence Interval
groups
  1. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-R CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    OG000
    title
    Bosutinib 500 mg, CP2L-CML IM-R (Part 2)
  2. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP2L IM-I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    OG001
    title
    Bosutinib 500 mg, CP2L-CML IM-I (Part 2)
  3. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I, D and NI R/I or IM R/I and NI-I CML.
    id
    OG002
    title
    Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)
  4. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-R CML.
    id
    OG003
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)
  5. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and D-I CML.
    id
    OG004
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)
  6. description
    Bosutinib 500 mg was administered orally once-daily in participants with CP3L IM R/I and NI-R CML.
    id
    OG005
    title
    Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)
  7. description
    Bosutinib 500 mg was administered orally once-daily in participants with AP IM R/I CML; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    OG006
    title
    Bosutinib 500 mg, AP-CML IM R/I (Part 2)
  8. description
    Bosutinib 500 mg was administered orally once-daily in participants with AP Multi-TKI: IM, D and/or NI R/I CML.
    id
    OG007
    title
    Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)
  9. description
    Bosutinib 500 mg was administered orally once-daily in participants with BP IM R/I CML ; who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
    id
    OG008
    title
    Bosutinib 500 mg, BP-CML IM R/I (Part 2)
  10. description
    Bosutinib 500 mg was administered orally once-daily in participants with BP Multi-TKI: IM, D and/or NI R/I CML.
    id
    OG009
    title
    Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)
  11. description
    Bosutinib 500 mg was administered orally once-daily in participants with Ph+ ALL
    id
    OG010
    title
    Bosutinib 500 mg, Ph+ ALL (Part 2)
param Type
MEDIAN
population Description
Subgroup of participants from evaluable population who had confirmed CHR.
reporting Status
POSTED
time Frame
From date of first confirmed CHR to loss of CHR or censoring, assessed at Day 1 and 7 of Week 1, Day 7 of Week 2, 3, 4, 8, 12, thereafter assessed every 12 weeks up to 2 years then every 24 weeks thereafter up to Year 4 (CP3L and ADV) or Year 5 (CP2L)
title
Duration of Complete Hematologic Response (CHR) - Part 2
type
SECONDARY
unit Of Measure
weeks

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Preserved source evidence · Not medical advice