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NCT00306202 · OUTCOME

Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML)

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
Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; at Week 10 (only stratum 4); then every 12 weeks upto 24 months; then once/year; EOT(Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])

What was measured

Defined as participants having as best response complete hematologic response (CHR) or CHR with incomplete platelet recovery (CHRp). Criteria: CHR-WBC in Peripheral Blood (PB):≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm\^3 and ≤450,000/mm\^3; ANC:≥ 1000/mm\^3; Blasts in BM:\<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement). CHRp-CHR except platelet count (untransfused) \& ANC:20,000/mm\^3 ≤platelet \<100,000/mm\^3 \& /or 500/mm\^3 ≤ANC ≤1000/mm\^3.

Analysis population: All treated participants in strata 2/3 and 4: Participants who received at least 1 dose of study therapy.

Groups in this outcome

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 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 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)2Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)6Not reportedNot reportedNot reportedNot reported
Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)0Not 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)0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      9
    3. group Id
      OG002
      value
      6
    4. group Id
      OG003
      value
      6
    5. group Id
      OG004
      value
      6
    6. group Id
      OG005
      value
      6
    units
    Participants
description
Defined as participants having as best response complete hematologic response (CHR) or CHR with incomplete platelet recovery (CHRp). Criteria: CHR-WBC in Peripheral Blood (PB):≤ULN; Immature cells in PB:No blasts, promyelocytes, myelocytes, metamyelocytes; Platelet count (untransfused):≥100,000/mm\^3 and ≤450,000/mm\^3; ANC:≥ 1000/mm\^3; Blasts in BM:\<5%; Extra medullary disease:No extramedullary leukemia, including no hepato or splenomegaly (regardless of CNS involvement). CHRp-CHR except platelet count (untransfused) \& ANC:20,000/mm\^3 ≤platelet \<100,000/mm\^3 \& /or 500/mm\^3 ≤ANC ≤1000/mm\^3.
groups
  1. 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
    OG000
    title
    Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)
  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). Dasatinib 80 mg/m\^2 QD, as long as clinical benefit was maintained.
    id
    OG001
    title
    Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)
  3. 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
    OG002
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)
  4. 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
    OG003
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)
  5. 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
    OG004
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)
  6. 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
    OG005
    title
    Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)
param Type
NUMBER
population Description
All treated participants in strata 2/3 and 4: Participants who received at least 1 dose of study therapy.
reporting Status
POSTED
time Frame
Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; at Week 10 (only stratum 4); then every 12 weeks upto 24 months; then once/year; EOT(Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72]; Stratum 4=1.14 [Range: 0.03-3.38])
title
Number of Participants With Major Hematologic Response (MaHR) at Any Time in Stratum 2/3 (Ph+ ALL or AP/BP-CML) and Stratum 4 (Ph- ALL/AML)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice