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NCT00306202 · OUTCOME

Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML

Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia · Source last updated 2021-02-26

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
At baseline (within 3 weeks before initiation of study therapy)

What was measured

BCR-ABL, also referred to as the Philadelphia chromosome, is formed from the fusion of the BCR gene on chromosome 22 with the ABL gene on chromosome 9.

Analysis population: All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.

Groups in this outcome

Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained.

Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose

Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.

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

Analysis denominator · Participants

GroupSource count
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose17
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose17

Reported measurements

L384M
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose1Not reportedNot reportedNot reportedNot reported
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose0Not reportedNot reportedNot reportedNot reported
G250E
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose1Not reportedNot reportedNot reportedNot reported
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose0Not reportedNot reportedNot reportedNot reported
T315I
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose0Not reportedNot reportedNot reportedNot reported
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose1Not reportedNot reportedNot reportedNot reported
Y253H
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose0Not reportedNot reportedNot reportedNot reported
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose1Not reportedNot reportedNot reportedNot reported
Y253F
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose0Not reportedNot reportedNot reportedNot reported
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose1Not reportedNot reportedNot reportedNot reported
No Mutation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose15Not reportedNot reportedNot reportedNot reported
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose11Not reportedNot reportedNot reportedNot reported
No Data
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose0Not reportedNot reportedNot reportedNot reported
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    L384M
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
    title
    G250E
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    T315I
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Y253H
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Y253F
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        15
      2. group Id
        OG001
        value
        11
    title
    No Mutation
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
    title
    No Data
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      17
    units
    Participants
description
BCR-ABL, also referred to as the Philadelphia chromosome, is formed from the fusion of the BCR gene on chromosome 22 with the ABL gene on chromosome 9.
groups
  1. description
    Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. Once daily (QD), as long as clinical benefit was maintained.
    id
    OG000
    title
    Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose
  2. description
    Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML). Starting Dose Level of 60 mg/m\^2; Escalated/Dose Level 2 of 80 mg/m\^2. QD, as long as clinical benefit was maintained.
    id
    OG001
    title
    Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose
param Type
NUMBER
population Description
All treated participants in strata 1 and 2/3: Participants who received at least 1 dose of study therapy.
reporting Status
POSTED
time Frame
At baseline (within 3 weeks before initiation of study therapy)
title
Number of Participants With BCR-ABL Mutations at Baseline: Stratum1 Ph+ CP-CML and Stratum 2/3 Ph+ALL or AP/BP-CML
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice