NCT00306202 · OUTCOME

Progression Free Survival (PFS)

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: MEDIAN
Unit: months
Interval / dispersion: 95% Confidence Interval
Time frame: From the date of randomization to date of progression, death, last tumor assessment, or 5 years after 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]; Stratum 4=1.14 [Range: 0.03-3.38])

What was measured

Time in months from 1st first dose until progression (resistance or refractory disease) or death was first documented by investigator. Progressive disease: Resistant disease for which investigator may electively stop treatment or refractory disease requiring cessation of study treatment. The PFS was estimated using the Kaplan-Meier product-limit method, and a two-sided 95% CI for the median PFS time was computed using the method of Brookmeyer and Crowley.

Analysis population: All treated participants: Participants who received at least 1 dose of study therapy. If no progression or death was reported, PFS was censored at the last assessment date done on-study (i.e., up to 30 days after last dosing date) at which non-progression was reported.

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. 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.

Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose

Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2, Escalated/Dose level 3 of 100 mg/m\^2, and Escalated/Dose level 4 of 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

Group	Source count
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose	17
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose	17
Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose	24

Reported measurements

Source class 1

Values in months · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose	53.6	Not reported	11.4	NA	Upper limit not reached
Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose	4.9	Not reported	0.6	8.4	Not reported
Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose	1.4	Not reported	0.4	1.6	Not reported

Complete source fields

classes

categories
measurements
comment
Upper limit not reached
group Id
OG000
lower Limit
11.4
upper Limit
NA
value
53.6
group Id
OG001
lower Limit
0.6
upper Limit
8.4
value
4.9
group Id
OG002
lower Limit
0.4
upper Limit
1.6
value
1.4

denoms

counts
group Id
OG000
value
17
group Id
OG001
value
17
group Id
OG002
value
24
units
Participants

description

dispersion Type

95% Confidence Interval

groups

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. QD, as long as clinical benefit was maintained.
id
OG000
title
Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose
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
description
Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m\^2; Escalated/Dose level 2 of 80 mg/m\^2, Escalated/Dose level 3 of 100 mg/m\^2, and Escalated/Dose level 4 of 120 mg/m\^2. QD, as long as clinical benefit was maintained.
id
OG002
title
Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose

param Type

MEDIAN

population Description

All treated participants: Participants who received at least 1 dose of study therapy. If no progression or death was reported, PFS was censored at the last assessment date done on-study (i.e., up to 30 days after last dosing date) at which non-progression was reported.

reporting Status

POSTED

time Frame

From the date of randomization to date of progression, death, last tumor assessment, or 5 years after 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]; Stratum 4=1.14 [Range: 0.03-3.38])

title

Progression Free Survival (PFS)

type

SECONDARY

unit Of Measure

months

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Preserved source evidence · Not medical advice