NCT00777036 · CITED IN SOURCE DOCUMENTS

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2025-08-29

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Major Cytogenetic Response (MCyR) Rate

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outcome · POSTED

Complete Hematologic Response (CHR) Rate

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outcome · POSTED

Complete Cytogenetic Response (CCyR) Rate

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outcome · POSTED

Major Cytogenetic Response (MCyR) Rate in Cohort 2

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outcome · POSTED

Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3

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outcome · POSTED

Rate of Best Cytogenetic Response

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outcome · POSTED

Time to Major Cytogenetic Response (MCyR)

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outcome · POSTED

Duration of Major Cytogenetic Response (MCyR)

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outcome · POSTED

Time to Complete Cytogenetic Response (CCyR)

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outcome · POSTED

Duration of Complete Cytogenetic Response (CCyR)

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outcome · POSTED

Progression-Free Survival (PFS)

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outcome · POSTED

Time to Complete Hematologic Response (CHR)

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outcome · POSTED

Duration of Complete Hemotologic Response (CHR)

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outcome · POSTED

Disease-Free Survival

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Major Molecular Response (MMR) Rate

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outcome · POSTED

Complete Molecular Response (CMR) Rate

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outcome · POSTED

Major Cytogenetic Response (MCyR) Rate up to 2 Years

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outcome · POSTED

Complete Cytogenetic Response (CCyR) Rate up to 2 Years

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outcome · POSTED

Major Molecular Response (MMR) Rate up to 7.5 Years

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outcome · POSTED

Complete Molecular Response (CMR) Rate up to 7.5 Years

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * CP-CML who prove resistant or intolerant to imatinib (Cohort 1) * Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (Cohort 2) * Newly diagnosed, treatment naive CP-CML (Cohort 3) * Lansky or Karnofsky scale \>50 * Life expectancy ≥12 weeks * Adequate hepatic and renal function * Written informed consent * Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation * Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy * Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2 * Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible * Target Population for the PK substudy subjects must meet relevant inclusion criteria Exclusion Criteria: * Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation * Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease) * Isolated extramedullary disease * Prior therapy with Dasatinib * Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria * Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy Other inclusion/exclusion criteria may apply
healthy Volunteers: false
maximum Age: 18 Years
minimum Age: 1 Day
sex: ALL
std Ages: CHILD
ADULT

Treatment arms and interventions

arm Groups

description
Dasatinib 60 mg/m² tablet every day (QD) \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² powder for oral suspension (PFOS) QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit
intervention Names
Drug: Dasatinib
label
Cohort 1: Imatinib-resistant/intolerant CP-CML
type
EXPERIMENTAL
description
Dasatinib 80 mg/m² tablet QD \[with a maximum dose of 140 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 96 mg/m² PFOS QD \[with a maximum dose of 170 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit
intervention Names
Drug: Dasatinib
label
Cohort 2: Ph+ALL or AP- or BP-CML
type
EXPERIMENTAL
description
Dasatinib 60 mg/m² tablet QD \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² PFOS QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit
intervention Names
Drug: Dasatinib
label
Cohort 3: Newly diagnosed, treatment naïve CP-CML
type
EXPERIMENTAL

interventions

arm Group Labels
Cohort 1: Imatinib-resistant/intolerant CP-CML
Cohort 2: Ph+ALL or AP- or BP-CML
Cohort 3: Newly diagnosed, treatment naïve CP-CML
name
Dasatinib
other Names
Sprycel (BMS-354825)
type
DRUG

Study design

allocation

NON_RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 133
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Major Cytogenetic Response (MCyR) rate is defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response, expressed as percentage. The denominator of the MCyR response rate consists of all treated participants in Cohort 1, and the numerator is all participants in Cohort 1 achieving MCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.
measure
Major Cytogenetic Response (MCyR) Rate
time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
description
Complete Hematologic Response (CHR) rate is defined as the proportion of all treated participants who achieve a confirmed CHR while on-study, expressed as percentage. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood, expressed as percentage. The denominator of the CHR response rate consists of all treated participants in Cohort 2, and the numerator is all participants in Cohort 2 achieving CHR. 95% confidence interval was calculated by Clopper-Pearson exact method.
measure
Complete Hematologic Response (CHR) Rate
time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
description
Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study, expressed as a percentage. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The denominator of the CCyR response rate consists of all treated participants in Cohort 3, and the numerator is all participants in Cohort 3 achieving CCyR. 95% confidence interval was calculated by Clopper-Pearson exact method.
measure
Complete Cytogenetic Response (CCyR) Rate
time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

secondary Outcomes

description
Major Cytogenetic Response (MCyR) rate was defined as the proportion of all treated participants who achieved a complete (0%) or partial (1%-35% Ph+ metaphases in at least 20 metaphases in bone marrow) cytogenetic response. The percentage of treated participants in each arm with MCyR is reported.
measure
Major Cytogenetic Response (MCyR) Rate in Cohort 2
time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
description
Complete Hematologic Response (CHR) rate defined as the proportion of all treated participants who achieve a confirmed CHR while on-study. CHR is defined as including no more than 5% blasts in bone marrow and normal white blood cell count without blasts in peripheral blood. The percentage of treated participants in each arm with CHR is reported.
measure
Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3
time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
description
The number of participants achieving their best on-study cytogenetic response was reported as a percentage of all treated participants in that arm. (Based on \>=20 Metaphases)
measure
Rate of Best Cytogenetic Response
time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
description
Time to MCyR is defined as the time from first dose of dasatinib until the first day MCyR criteria are met, computed only for participants whose best response is MCyR. (Based on \>=20 Metaphases)
measure
Time to Major Cytogenetic Response (MCyR)
time Frame
From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)
description
Duration of MCyR will be computed from the first day criteria are met for MCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on \>=20 Metaphases)
measure
Duration of Major Cytogenetic Response (MCyR)
time Frame
From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)
description
Time to CCyR is defined as the time from first dose of dasatinib until the first day CCyR criteria are met, computed only for participants whose best response is CCyR. (Based on \>=20 Metaphases)
measure
Time to Complete Cytogenetic Response (CCyR)
time Frame
From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)
description
Duration of CCyR will be computed from the first day criteria are met for CCyR until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic or cytogenetic assessment, whichever comes last. (Based on \>=20 Metaphases)
measure
Duration of Complete Cytogenetic Response (CCyR)
time Frame
From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)
description
PFS is defined as time from the first dosing date until the time PD is first documented by the investigator or death. Participants who die without a reported date of progression will be considered to have progressed on the date of death. Participants who neither progress nor die will be censored on the date of their last cytogenetic or hematologic assessment. Based on Kaplan-Meier methodology. Disease Progression was defined as any of the following criteria: -For CP-CML, progression to AP-CML or BP-CML while at highest tolerated dose -Increasing WBC -Loss of CHR (defined as any of the following: WBC count rises to \>20.0x10\^9/L; Platelet count rises to \>600x10\^9/L; appearance of extramedullary disease; appearance of \>5% myelocytes+metamyelocytes in blood; appearance of blasts/promyelocytes in peripheral blood) -Loss of MCyR or increase in Ph+ bone marrow cells by \>=30% from nadir -Death from any case during treatment.
measure
Progression-Free Survival (PFS)
time Frame
174 Months
description
Time to CHR is defined as the time from first dose of dasatinib until the first day CHR criteria are met, provided they are confirmed 4 weeks later, computed only for participants whose best response is CHR.
measure
Time to Complete Hematologic Response (CHR)
time Frame
From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)
description
Duration of CHR will be computed from the first day all criteria are met for CHR, provided they are confirmed 4 weeks later, until the date progressive disease (PD) is reported (or treatment is discontinued for PD) or death. Participants who neither discontinue due to PD nor die will be censored on the date of their last hematologic assessment.
measure
Duration of Complete Hemotologic Response (CHR)
time Frame
From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)
description
Disease free survival is defined as time from CCyR for participants with newly diagnosed chronic phase CML and for participants with chronic phase CML who are resistant or intolerant to imatinib (cohort 3 and cohort 1), and as time from CHR for participants with advanced phase CML and PH + ALL (cohort 2) until the time progression is first documented by the investigator or death from any cause. Based on Kaplan-Meier methodology. (CML: Chronic Myeloid Leukemia).
measure
Disease-Free Survival
time Frame
168 Months
description
OS is defined as time from the first dosing date until the time of death. All participants will be followed yearly for survival for up to 5 years after treatment discontinuation. Participants who have not died or who are lost to follow-up will be censored on the last date the participant is known to be alive. Based on Kaplan-Meier methodology using graphs.
measure
Overall Survival (OS)
time Frame
174 Months

Full study description

brief Summary: The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Source references

references

citation
Gore L, Kearns PR, de Martino ML, Lee, De Souza CA, Bertrand Y, Hijiya N, Stork LC, Chung NG, Cardos RC, Saikia T, Fagioli F, Seo JJ, Landman-Parker J, Lancaster D, Place AE, Rabin KR, Sacchi M, Swanink R, Zwaan CM. Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Phase II Trial. J Clin Oncol. 2018 May 1;36(13):1330-1338. doi: 10.1200/JCO.2017.75.9597. Epub 2018 Mar 2.
pmid
29498925
type
DERIVED