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NCT00306202 · OUTCOME

Best Hematologic Response (HR) At Any Time: 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
Days 8, 15, 22, 29, 36, 43; Weeks 4, 7, 13, 19, 25, 31, 37; then every 12 weeks up to 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])

What was measured

HR was determined by CBC, differential, and platelet count. Refer to outcome measure 15 for criteria for CHR and CHRp. Criteria for minor hematologic response (MiHR): CHRp except blasts in BM-≥5% and ≤15% blasts in BM. Unconfirmed HR = All criteria met. periph=peripheral. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.

Analysis population: All treated participants in Stratum 2/3: 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.

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

Reported measurements

Best Confirmed HR-Complete
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)5Not reportedNot reportedNot reportedNot reported
Best Confirmed HR-Complete except periph. recovery
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Best Confirmed HR-No Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)6Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)3Not reportedNot reportedNot reportedNot reported
Best Unconfirmed HR-Complete
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)3Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)7Not reportedNot reportedNot reportedNot reported
Best Unconfirmed HR-Minor
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
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)1Not reportedNot reportedNot reportedNot reported
Best Unconfirmed HR-No Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)5Not reportedNot reportedNot reportedNot reported
Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        5
    title
    Best Confirmed HR-Complete
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Best Confirmed HR-Complete except periph. recovery
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
    title
    Best Confirmed HR-No Response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        7
    title
    Best Unconfirmed HR-Complete
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
    title
    Best Unconfirmed HR-Minor
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        1
    title
    Best Unconfirmed HR-No Response
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      9
    units
    Participants
description
HR was determined by CBC, differential, and platelet count. Refer to outcome measure 15 for criteria for CHR and CHRp. Criteria for minor hematologic response (MiHR): CHRp except blasts in BM-≥5% and ≤15% blasts in BM. Unconfirmed HR = All criteria met. periph=peripheral. Confirmed HR = Criteria for HR fulfilled again at least 28 days after they first met with no concomitant use of anagrelide or hydroxyurea during this interval.
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)
param Type
NUMBER
population Description
All treated participants in Stratum 2/3: 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; then every 12 weeks up to 24 months; then once/year; EOT (Median duration of therapy in months: Stratum 2/3=3.02 [Range: 0.53-37.72])
title
Best Hematologic Response (HR) At Any Time: 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