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NCT00306202 · OUTCOME

Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 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 EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])

What was measured

BCR-ABL = These are fused genes found in participants with this type of leukemia.

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

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 Dose4Not reportedNot reportedNot reportedNot reported
No Mutation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose8Not reportedNot reportedNot reportedNot reported
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose9Not reportedNot reportedNot reportedNot reported
No Data
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose9Not reportedNot reportedNot reportedNot reported
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        4
    title
    T315I
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        9
    title
    No Mutation
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        4
    title
    No Data
denoms
  1. counts
    1. group Id
      OG000
      value
      17
    2. group Id
      OG001
      value
      17
    units
    Participants
description
BCR-ABL = These are fused genes found in participants with this type of leukemia.
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 EOT (Median duration of therapy in months: Stratum 1=24.11 [Range: 2.27-50.63]; Stratum 2/3=3.02 [Range: 0.53-37.72])
title
Number of Participants With BCR-ABL Mutations at End-of-Treatment: Stratum1 Ph+ CP-CML and Stratum2/3 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