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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

Primary Purpose

Leukemia

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Dasatinib
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring Leukemia, Pediatric

Eligibility Criteria

1 Day - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Local Institution
  • Local Institution - 0005
  • Phoenix Children'S Hospital
  • Jonathan Jaques Children'S Cancer Center
  • Jonathan Jaques Children'S Cancer Center
  • Local Institution - 0001
  • Children'S Hospital Of Orange County
  • Local Institution - 0024
  • Children'S Hospital
  • Local Institution - 0004
  • Children's Healthcare of Atlanta - Egleston Hospital
  • Children's Healthcare Of Atlanta - Egleston
  • Children's Hospital of Chicago
  • Local Institution - 0072
  • Local Institution
  • Dana Faber Cancer Institute
  • Dana Farber Cancer Institute.
  • Local Institution - 0040
  • Stephen D. Hassenfeld Children'S Center
  • Local Institution - 0061
  • Memorial Sloan Kettering Cancer Center
  • Memorial Sloan Kettering Nassau
  • Oregon Health & Sci Univ
  • Local Institution - 0002
  • Oregon Health & Sci Univ
  • Children'S Hospital Of Philadelphia
  • Local Institution - 0014
  • Children'S Hospital Of Pittsburgh
  • Local Institution - 0003
  • Local Institution - 0035
  • MD Anderson Cancer Center
  • Local Institution - 0048
  • Texas Children'S Cancer Center
  • Local Institution - 0028
  • Seattle Children'S
  • Local Institution - 0043
  • Local Institution
  • Hospital Nacional Profesor Alejandro Posadas
  • Local Institution - 0049
  • Local Institution - 0042
  • Local Institution
  • Local Institution - 065
  • Local Institution
  • Local Institution - 069
  • Local Institution
  • Local Institution - 0064
  • Local Institution
  • Local Institution - 067
  • Local Institution
  • Local Institution - 0066
  • Local Institution
  • Local Institution - 0021
  • Local Institution
  • Local Institution - 0022
  • Local Institution
  • Local Institution - 0019
  • Local Institution - 0020
  • Local Institution
  • Local Institution - 0039
  • Local Institution
  • Local Institution
  • Alberta Children'S Hospital
  • Local Institution - 0079
  • Local Institution - 0078
  • Stollery Children'S Hospital
  • Bc Children'S Hospital
  • Local Institution - 077
  • Iwk Health Centre
  • Local Institution - 073
  • Children'S Hospital Of Eastern Ontario
  • Local Institution - 086
  • Local Institution - 076
  • The Hospital For Sick Children
  • Chu Ste-Justine
  • Local Institution - 080
  • Local Institution - 0030
  • Local Institution
  • Local Institution - 0032
  • Local Institution
  • Local Institution
  • Local Institution - 0037
  • Local Institution
  • Local Institution - 0029
  • Local Institution
  • Local Institution - 036
  • Local Institution
  • Local Institution - 075
  • Local Institution
  • Local Institution - 0074
  • Local Institution
  • Local Institution - 0089
  • Local Institution
  • Local Institution
  • Local Institution
  • Local Institution - 0094
  • Local Institution
  • Local Institution - 0093
  • Local Institution
  • Local Institution
  • Local Institution - 0088
  • Local Institution - 0082
  • Local Institution
  • Local Institution - 0085
  • Local Institution
  • Local Institution - 0084
  • Local Institution
  • Local Institution - 038
  • Local Institution
  • Local Institution
  • Local Institution - 006
  • Local Institution - 070
  • Local Institution
  • Local Institution - 0059
  • Local Institution
  • Local Institution - 015
  • Local Institution
  • Local Institution - 0092
  • Local Institution
  • Local Institution - 0091
  • Local Institution
  • Local Institution - 0051
  • Local Institution
  • Local Institution - 0052
  • Local Institution
  • Local Institution
  • Local Institution - 0053
  • Local Institution
  • Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca
  • Local Institution - 0054
  • Local Institution - 0060
  • Local Institution
  • Local Institution - 0050
  • Local Institution
  • Local Institution - 0007
  • Local Institution
  • Local Institution - 0099
  • Local Institution - 0095
  • Local Institution
  • Local Institution - 0097
  • Local Institution - 0017
  • Local Institution
  • Local Institution - 0023
  • Local Institution
  • Local Institution - 0018
  • Local Institution
  • Local Institution - 0071
  • Local Institution
  • Local Institution - 0055
  • Local Institution
  • Local Institution - 058
  • Local Institution
  • Local Institution - 0057
  • Local Institution
  • Local Institution - 062
  • Local Institution
  • Local Institution - 0013
  • Local Institution
  • Local Institution - 0012
  • Local Institution
  • Local Institution - 0011
  • Local Institution
  • Local Institution - 0010
  • Local Institution
  • Local Institution - 0041
  • Local Institution
  • Local Institution - 0033
  • Local Institution
  • Local Institution
  • Local Institution - 0016
  • Local Institution
  • Local Institution - 0009
  • Local Institution
  • Local Institution - 0008
  • Local Institution

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Cohort 1: Imatinib-resistant/intolerant CP-CML

Cohort 2: Ph+ALL or AP- or BP-CML

Cohort 3: Newly diagnosed, treatment naïve CP-CML

Arm 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

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

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

Outcomes

Primary Outcome Measures

Major Cytogenetic Response (MCyR) Rate
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.
Complete Hematologic Response (CHR) Rate
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.
Complete Cytogenetic Response (CCyR) Rate
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.

Secondary Outcome Measures

Major Cytogenetic Response (MCyR) Rate in Cohort 2
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.
Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3
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.
Rate of Best Cytogenetic Response
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)
Time to Major Cytogenetic Response (MCyR)
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)
Duration of Major Cytogenetic Response (MCyR)
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)
Time to Complete Cytogenetic Response (CCyR)
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)
Duration of Complete Cytogenetic Response (CCyR)
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)
Progression-Free Survival (PFS) Rate at 2 Years
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. The percentages of progression-free participants at 2 years are based on Kaplan-Meier estimation. 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
Time to Complete Hematologic Response (CHR)
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.
Duration of Complete Hemotologic Response (CHR)
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.
Disease-Free Survival Rate at 2 Years
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. The percentages of disease-free participants at 2 years are based on Kaplan-Meier estimation. (CML: Chronic Myeloid Leukemia)
Overall Survival (OS) Rate at 2 Years
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. The percentages of surviving participants at 2 years are based on Kaplan-Meier estimation.
Major Molecular Response (MMR) Rate
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline was considered an MMR.
Complete Molecular Response (CMR) Rate
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.
Major Cytogenetic Response (MCyR) Rate up to 2 Years
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. The percentage of treated participants with MCyR is reported by arm.
Complete Cytogenetic Response (CCyR) Rate up to 2 Years
Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.
Major Molecular Response (MMR) Rate up to 2 Years
Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.
Complete Molecular Response (CMR) Rate up to 2 Years
Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.

Full Information

First Posted
October 21, 2008
Last Updated
August 31, 2023
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00777036
Brief Title
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
Official Title
A Phase II Study of Dasatinib Therapy in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or With Ph+ Leukemias Resistant or Intolerant to Imatinib
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2009 (Actual)
Primary Completion Date
September 1, 2016 (Actual)
Study Completion Date
December 7, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
Leukemia, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1: Imatinib-resistant/intolerant CP-CML
Arm Type
Experimental
Arm 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
Arm Title
Cohort 2: Ph+ALL or AP- or BP-CML
Arm Type
Experimental
Arm 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
Arm Title
Cohort 3: Newly diagnosed, treatment naïve CP-CML
Arm Type
Experimental
Arm 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 Type
Drug
Intervention Name(s)
Dasatinib
Other Intervention Name(s)
Sprycel (BMS-354825)
Primary Outcome Measure Information:
Title
Major Cytogenetic Response (MCyR) Rate
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.
Time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Title
Complete Hematologic Response (CHR) Rate
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.
Time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Title
Complete Cytogenetic Response (CCyR) Rate
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.
Time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Secondary Outcome Measure Information:
Title
Major Cytogenetic Response (MCyR) Rate in Cohort 2
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.
Time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Title
Complete Hematologic Response (CHR) Rate in Cohorts 1 and 3
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.
Time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Title
Rate of Best Cytogenetic Response
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)
Time Frame
From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
Title
Time to Major Cytogenetic Response (MCyR)
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)
Time Frame
From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)
Title
Duration of Major Cytogenetic Response (MCyR)
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)
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)
Title
Time to Complete Cytogenetic Response (CCyR)
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)
Time Frame
From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)
Title
Duration of Complete Cytogenetic Response (CCyR)
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)
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)
Title
Progression-Free Survival (PFS) Rate at 2 Years
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. The percentages of progression-free participants at 2 years are based on Kaplan-Meier estimation. 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
Time Frame
2 years
Title
Time to Complete Hematologic Response (CHR)
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.
Time Frame
From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)
Title
Duration of Complete Hemotologic Response (CHR)
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.
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)
Title
Disease-Free Survival Rate at 2 Years
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. The percentages of disease-free participants at 2 years are based on Kaplan-Meier estimation. (CML: Chronic Myeloid Leukemia)
Time Frame
2 years
Title
Overall Survival (OS) Rate at 2 Years
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. The percentages of surviving participants at 2 years are based on Kaplan-Meier estimation.
Time Frame
2 years
Title
Major Molecular Response (MMR) Rate
Description
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). MMR for participants with the p210 BCR-ABL transcript variant was defined as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale. In this study, ABL was used as the control-gene. For a participant with the p190 BCR-ABL transcript variant (occurring in Cohort 2 only), on-study assessments were compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline was considered an MMR.
Time Frame
From date of first treatment to date of MMR (assessed up to September 2016, approximately 90 months)
Title
Complete Molecular Response (CMR) Rate
Description
Molecular response was assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.
Time Frame
From date of first treatment to date of CMR (assessed up to September 2016, approximately 90 months)
Title
Major Cytogenetic Response (MCyR) Rate up to 2 Years
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. The percentage of treated participants with MCyR is reported by arm.
Time Frame
24 months
Title
Complete Cytogenetic Response (CCyR) Rate up to 2 Years
Description
Complete Cytogenetic Response (CCyR) rate is defined as the proportion of all treated participants who achieve a CCyR while on-study. CCyR rate is defined as 0% Ph+ metaphases in at least 20 metaphases in bone marrow. The percentage of treated participants with CCyR is reported by arm.
Time Frame
24 months
Title
Major Molecular Response (MMR) Rate up to 2 Years
Description
Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time qPCR. MMR for participants with the p210 BCR-ABL transcript variant is defined according to the recommendations of Hughes et al. as a ratio BCR-ABL/ABL <= 10-3 or 0.1% on the international scale proposed by the authors. The standardized baseline, as established in the IRIS trial, is taken to represent 100% on the international scale and a 3-log reduction in ratio (BCR-ABL transcripts/ABL or BCR) from the standardized baseline (MMR) is fixed at 0.1%. In this study, ABL or other housekeeping gene, will be used as the control-gene. For a participant with the p190 BCR-ABL transcript variant, on-study assessments will be compared to the participant's individual baseline BCR-ABL/ABL ratio and a reduction to < 0.1% or a 3-log reduction from baseline will be considered an MMR. The percentage of treated participants with MMR is reported by arm.
Time Frame
24 months
Title
Complete Molecular Response (CMR) Rate up to 2 Years
Description
Molecular response will be assessed using BCR-ABL transcript levels measurement by real-time quantitative polymerase chain reaction (qPCR). (CMR) is defined as absence of BCR-ABL rearrangements by real-time qPCR analysis. The percentage of treated participants with CMR is reported by arm.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Local Institution - 0005
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Phoenix Children'S Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Jonathan Jaques Children'S Cancer Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90801-1428
Country
United States
Facility Name
Jonathan Jaques Children'S Cancer Center
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Local Institution - 0001
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Children'S Hospital Of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Local Institution - 0024
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Children'S Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Local Institution - 0004
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Children's Healthcare of Atlanta - Egleston Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Children's Healthcare Of Atlanta - Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Local Institution - 0072
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Local Institution
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Dana Faber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana Farber Cancer Institute.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Local Institution - 0040
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Stephen D. Hassenfeld Children'S Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Local Institution - 0061
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Memorial Sloan Kettering Nassau
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Oregon Health & Sci Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Local Institution - 0002
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Oregon Health & Sci Univ
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Children'S Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4318
Country
United States
Facility Name
Local Institution - 0014
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4318
Country
United States
Facility Name
Children'S Hospital Of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Local Institution - 0003
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Local Institution - 0035
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Local Institution - 0048
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children'S Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution - 0028
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Seattle Children'S
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Local Institution - 0043
City
Bunos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Local Institution
City
Bunos Aires
State/Province
Buenos Aires
ZIP/Postal Code
1425
Country
Argentina
Facility Name
Hospital Nacional Profesor Alejandro Posadas
City
El Palomar
State/Province
Buenos Aires
ZIP/Postal Code
1684
Country
Argentina
Facility Name
Local Institution - 0049
City
El Palomar
State/Province
Buenos Aires
ZIP/Postal Code
1684
Country
Argentina
Facility Name
Local Institution - 0042
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Local Institution
City
Cordoba
ZIP/Postal Code
5016
Country
Argentina
Facility Name
Local Institution - 065
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Local Institution
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Local Institution - 069
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Local Institution - 0064
City
Sth Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Local Institution
City
Sth Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Local Institution - 067
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Local Institution
City
North Adelaide
State/Province
South Australia
ZIP/Postal Code
5006
Country
Australia
Facility Name
Local Institution - 0066
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Local Institution
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Facility Name
Local Institution - 0021
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Local Institution
City
Curitiba
State/Province
Parana
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Local Institution - 0022
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Local Institution
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Local Institution - 0019
City
São Paulo
State/Province
SAO Paulo
ZIP/Postal Code
04520-013
Country
Brazil
Facility Name
Local Institution - 0020
City
Campinas
ZIP/Postal Code
13083-970
Country
Brazil
Facility Name
Local Institution
City
Campinas
ZIP/Postal Code
13083-970
Country
Brazil
Facility Name
Local Institution - 0039
City
Sao Paulo
ZIP/Postal Code
01401-000
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
01401-000
Country
Brazil
Facility Name
Local Institution
City
Sao Paulo
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Alberta Children'S Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Local Institution - 0079
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
Local Institution - 0078
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Stollery Children'S Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Bc Children'S Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
Local Institution - 077
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
Iwk Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
Local Institution - 073
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
Children'S Hospital Of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Local Institution - 086
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
Local Institution - 076
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
The Hospital For Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Chu Ste-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Local Institution - 080
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Local Institution - 0030
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Local Institution
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Local Institution - 0032
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Local Institution
City
Paris Cedex 12
ZIP/Postal Code
75571
Country
France
Facility Name
Local Institution - 0037
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75012
Country
France
Facility Name
Local Institution - 0029
City
Paris
ZIP/Postal Code
75935
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75935
Country
France
Facility Name
Local Institution - 036
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Local Institution
City
Poitiers
ZIP/Postal Code
86000
Country
France
Facility Name
Local Institution - 075
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Local Institution - 0074
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Local Institution - 0089
City
Navrangpura, Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380009
Country
India
Facility Name
Local Institution
City
Navrangpura, Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380009
Country
India
Facility Name
Local Institution
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560027
Country
India
Facility Name
Local Institution
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400010
Country
India
Facility Name
Local Institution - 0094
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Local Institution
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411001
Country
India
Facility Name
Local Institution - 0093
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625107
Country
India
Facility Name
Local Institution
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625107
Country
India
Facility Name
Local Institution
City
Vellore
State/Province
Tamilnadu
ZIP/Postal Code
632004
Country
India
Facility Name
Local Institution - 0088
City
Bangalore
ZIP/Postal Code
560027
Country
India
Facility Name
Local Institution - 0082
City
Kolkatta
ZIP/Postal Code
700 016
Country
India
Facility Name
Local Institution
City
Kolkatta
ZIP/Postal Code
700 016
Country
India
Facility Name
Local Institution - 0085
City
Mumbai
ZIP/Postal Code
400010
Country
India
Facility Name
Local Institution
City
Mumbai
ZIP/Postal Code
400010
Country
India
Facility Name
Local Institution - 0084
City
Trivandrum
ZIP/Postal Code
695011
Country
India
Facility Name
Local Institution
City
Trivandrum
ZIP/Postal Code
695011
Country
India
Facility Name
Local Institution - 038
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution
City
Bologna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Local Institution
City
Monza (MB)
ZIP/Postal Code
20900
Country
Italy
Facility Name
Local Institution - 006
City
Monza
ZIP/Postal Code
20900
Country
Italy
Facility Name
Local Institution - 070
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution - 0059
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00165
Country
Italy
Facility Name
Local Institution - 015
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution - 0092
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Local Institution - 0091
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
137-701
Country
Korea, Republic of
Facility Name
Local Institution - 0051
City
Cuauhtémoc
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Local Institution
City
Df
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Local Institution - 0052
City
Mexico D.f.
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Local Institution
City
Mexico D.f.
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Local Institution
City
Mexico, D. F.
State/Province
Distrito Federal
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Local Institution - 0053
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Local Institution
City
Mexico
State/Province
Distrito Federal
ZIP/Postal Code
04530
Country
Mexico
Facility Name
Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Local Institution - 0054
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44340
Country
Mexico
Facility Name
Local Institution - 0060
City
Monterrey, N.l.
State/Province
Nuevo Leon
ZIP/Postal Code
64180
Country
Mexico
Facility Name
Local Institution
City
Monterrey, N.l.
State/Province
Nuevo Leon
ZIP/Postal Code
64180
Country
Mexico
Facility Name
Local Institution - 0050
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Local Institution - 0007
City
Rotterdam
ZIP/Postal Code
3015 GJ
Country
Netherlands
Facility Name
Local Institution
City
Rotterdam
ZIP/Postal Code
3015 GJ
Country
Netherlands
Facility Name
Local Institution - 0099
City
Utrecht
ZIP/Postal Code
3584 CS
Country
Netherlands
Facility Name
Local Institution - 0095
City
Bucharest
ZIP/Postal Code
022322
Country
Romania
Facility Name
Local Institution
City
Bucharest
ZIP/Postal Code
022322
Country
Romania
Facility Name
Local Institution - 0097
City
Sector 2
ZIP/Postal Code
022328
Country
Romania
Facility Name
Local Institution - 0017
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Local Institution - 0023
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
Local Institution - 0018
City
Saint-petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution
City
Saint-petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Local Institution - 0071
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Local Institution
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Facility Name
Local Institution - 0055
City
Bloemfontein
State/Province
FREE State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Local Institution
City
Bloemfontein
State/Province
FREE State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Local Institution - 058
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Local Institution
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0001
Country
South Africa
Facility Name
Local Institution - 0057
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Local Institution
City
Cape Town
State/Province
Western CAPE
ZIP/Postal Code
7925
Country
South Africa
Facility Name
Local Institution - 062
City
Tygerberg
State/Province
Western CAPE
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Local Institution
City
Tygerberg
State/Province
Western CAPE
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Local Institution - 0013
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Local Institution - 0012
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Local Institution - 0011
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Local Institution - 0010
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution - 0041
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Local Institution - 0033
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Local Institution
City
Valencia
Country
Spain
Facility Name
Local Institution - 0016
City
Glasgow
State/Province
Central
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
State/Province
Central
ZIP/Postal Code
G3 8SJ
Country
United Kingdom
Facility Name
Local Institution - 0009
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Local Institution
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Local Institution - 0008
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B4 6NH
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
29498925
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/us/en/home.html
Description
BMS Clinical Trial Patient Recruiting

Learn more about this trial

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

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