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NCT00306202 · OUTCOME

Number of Participants With Dose-limiting Toxicity (DLT)

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
From the date of first dose until at least 30 days after the last dose of study drug (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]; Stratum 4=1.14 [Range: 0.03-3.38])

What was measured

DLTs: AEs which were at least possibly drug-related occurring within first 3 weeks of dasatinib therapy (toxicities occurring after 21 days were also considered) and are:- --Any nonhematologic clinically-apparent toxicity of Grade(GR)≥3 occurring despite appropriate medical management and GR4 laboratory abnormality/GR3 lasting ≥7 days --GR4 neutropenia or thrombocytopenia lasting ≥7 days and not explained by the presence of leukemia after hematopoietic reconstitution --Any clinically important toxicity of GR≥2 requiring treatment discontinuation or interruption ≥7 days.

Analysis population: All treated participants: Participants who received at least 1 dose of study therapy.

Groups in this outcome

Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)

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). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)

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). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.

Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 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
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)11
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)6
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)8
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)9
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)6
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)6
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)6
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)6

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)0Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        0
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      11
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      9
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      6
    7. group Id
      OG006
      value
      6
    8. group Id
      OG007
      value
      6
    units
    Participants
description
DLTs: AEs which were at least possibly drug-related occurring within first 3 weeks of dasatinib therapy (toxicities occurring after 21 days were also considered) and are:- --Any nonhematologic clinically-apparent toxicity of Grade(GR)≥3 occurring despite appropriate medical management and GR4 laboratory abnormality/GR3 lasting ≥7 days --GR4 neutropenia or thrombocytopenia lasting ≥7 days and not explained by the presence of leukemia after hematopoietic reconstitution --Any clinically important toxicity of GR≥2 requiring treatment discontinuation or interruption ≥7 days.
groups
  1. description
    Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG000
    title
    Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)
  2. description
    Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG001
    title
    Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)
  3. 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). Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG002
    title
    Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)
  4. 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). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG003
    title
    Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
  5. description
    Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG004
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)
  6. description
    Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG005
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)
  7. description
    Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG006
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)
  8. description
    Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG007
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)
param Type
NUMBER
population Description
All treated participants: Participants who received at least 1 dose of study therapy.
reporting Status
POSTED
time Frame
From the date of first dose until at least 30 days after the last dose of study drug (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]; Stratum 4=1.14 [Range: 0.03-3.38])
title
Number of Participants With Dose-limiting Toxicity (DLT)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice