LeukemiaPhase 2NCT00777036

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

A Phase 2 study testing Dasatinib in people with Leukemia, run by Bristol-Myers Squibb at 174 sites in 18 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 1 day to 18 years
Conditions the study is for: Leukemia
What is being tested?: Dasatinib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 133 participants
Where: 174 sitesin 18 countries
Study dates: 20 Mar 2009to 27 Jan 2025
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 day to 18 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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

Show all 12Show fewer

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

Who cannot join

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

Trial locations and contacts

174 sites in 18 countries.

Country

City, postcode or hospital

174 sites in 18 countries

United States35 sites

Children's Healthcare Of Atlanta - Egleston
Atlanta, Georgia, 30322
Local Institution - 047
Atlanta, Georgia, 30322
Children'S Hospital
Aurora, Colorado, 80045
Local Institution - 0004
Aurora, Colorado, 80045
Local Institution
Birmingham, Alabama, 35233
Dana Faber Cancer Institute
Boston, Massachusetts, 02215
Dana Farber Cancer Institute.
Boston, Massachusetts, 02215
Local Institution - 0040
Boston, Massachusetts, 02215
Children's Hospital of Chicago
Chicago, Illinois, 60611
Local Institution - 0072
Chicago, Illinois, 60611
Local Institution
Chicago, Illinois, 60611
Local Institution - 0035
Houston, Texas, 77030-4009
MD Anderson Cancer Center
Houston, Texas, 77030-4009
Local Institution - 0048
Houston, Texas, 77030
Texas Children'S Cancer Center
Houston, Texas, 77030
Jonathan Jaques Children'S Cancer Center
Long Beach, California, 90801-1428
Jonathan Jaques Children'S Cancer Center
Long Beach, California, 90806
Local Institution - 0001
Long Beach, California, 90806
Stephen D. Hassenfeld Children'S Center
New York, New York, 10016
Local Institution - 0061
New York, New York, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Memorial Sloan Kettering Nassau
New York, New York, 10065
Children'S Hospital Of Orange County
Orange, California, 92868
Local Institution - 0024
Orange, California, 92868
Children'S Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104-4318
Local Institution - 0014
Philadelphia, Pennsylvania, 19104-4318
Local Institution - 0005
Phoenix, Arizona, 85016
Phoenix Children'S Hospital
Phoenix, Arizona, 85016
Children'S Hospital Of Pittsburgh
Pittsburgh, Pennsylvania, 15224
Local Institution - 0003
Pittsburgh, Pennsylvania, 15224
Oregon Health & Sci Univ
Portland, Oregon, 97239-3098
Local Institution - 0002
Portland, Oregon, 97239
Oregon Health & Sci Univ
Portland, Oregon, 97239
Local Institution - 0028
Seattle, Washington, 98105
Seattle Children'S
Seattle, Washington, 98105

Other trials in United States

India16 sites

Local Institution
Bangalore, Karnataka, 560027
Local Institution - 0088
Bangalore, 560027
Local Institution - 0082
Kolkata, 700 016
Local Institution
Kolkata, 700 016
Local Institution - 0093
Madurai, Tamil Nadu, 625107
Local Institution
Madurai, Tamil Nadu, 625107
Local Institution
Mumbai, Maharashtra, 400010
Local Institution - 0085
Mumbai, 400010
Local Institution
Mumbai, 400010
Local Institution - 0089
Navrangpura, Ahmedabad, Gujarat, 380009
Local Institution
Navrangpura, Ahmedabad, Gujarat, 380009
Local Institution - 0094
Pune, Maharashtra, 411001
Local Institution
Pune, Maharashtra, 411001
Local Institution - 0084
Trivandrum, 695011
Local Institution
Trivandrum, 695011
Local Institution
Vellore, Tamil Nadu, 632004

Other trials in India

Canada14 sites

Alberta Children'S Hospital
Calgary, Alberta, T3B 6A8
Local Institution - 0079
Calgary, Alberta, T3B 6A8
Local Institution - 0078
Edmonton, Alberta, T6G 2B7
Stollery Children'S Hospital
Edmonton, Alberta, T6G 2B7
Iwk Health Centre
Halifax, Nova Scotia, B3K 6R8
Local Institution - 073
Halifax, Nova Scotia, B3K 6R8
Chu Ste-Justine
Montreal, Quebec, H3T 1C5
Local Institution - 080
Montreal, Quebec, H3T 1C5
Children'S Hospital Of Eastern Ontario
Ottawa, Ontario, K1H 8L1
Local Institution - 086
Ottawa, Ontario, K1H 8L1
Local Institution - 076
Toronto, Ontario, M5G 1X8
The Hospital For Sick Children
Toronto, Ontario, M5G 1X8
Bc Children'S Hospital
Vancouver, British Columbia, V6H 3V4
Local Institution - 077
Vancouver, British Columbia, V6H 3V4

Other trials in Canada

Mexico13 sites

Local Institution - 0051
Cuauhtémoc, Mexico City, 06720
Local Institution
Df, Mexico City, 06720
Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca
Guadalajara, Jalisco, 44340
Local Institution - 0054
Guadalajara, Jalisco, 44340
Local Institution - 0053
Mexico City, Mexico City, 04530
Local Institution
Mexico City, Mexico City, 04530
Local Institution - 0052
Mexico City, Mexico City, 06726
Local Institution
Mexico City, Mexico City, 06726
Local Institution
Mexico, D. F., Mexico City, 06726
Local Institution - 0050
Monterrey, Nuevo León, 64460
Local Institution
Monterrey, Nuevo León, 64460
Local Institution - 0060
Monterrey, N.l., Nuevo León, 64180
Local Institution
Monterrey, N.l., Nuevo León, 64180

Other trials in Mexico

Spain13 sites

Local Institution - 0013
Barcelona, 08025
Local Institution
Barcelona, 08025
Local Institution - 0012
Barcelona, 08035
Local Institution
Barcelona, 08035
Local Institution - 0011
Madrid, 28009
Local Institution
Madrid, 28009
Local Institution - 0010
Madrid, 28046
Local Institution
Madrid, 28046
Local Institution - 0041
Málaga, 29010
Local Institution
Málaga, 29010
Local Institution - 0033
Valencia, 46009
Local Institution
Valencia, 46009
Local Institution
Valencia

Other trials in Spain

France11 sites

Local Institution - 0030
Lyon, 69008
Local Institution
Lyon, 69008
Local Institution - 0032
Nantes, 44093
Local Institution
Nantes, 44093
Local Institution - 0037
Paris, 75012
Local Institution
Paris, 75012
Local Institution
Paris, 75571
Local Institution - 0029
Paris, 75935
Local Institution
Paris, 75935
Local Institution - 036
Poitiers, 86000
Local Institution
Poitiers, 86000

Other trials in France

Australia10 sites

Local Institution - 067
North Adelaide, South Australia, 5006
Local Institution
North Adelaide, South Australia, 5006
Local Institution - 0066
Parkville, Victoria, 3052
Local Institution
Parkville, Victoria, 3052
Local Institution - 065
Randwick, New South Wales, 2031
Local Institution
Randwick, New South Wales, 2031
Local Institution - 0064
Sth Brisbane, Queensland, 4101
Local Institution
Sth Brisbane, Queensland, 4101
Local Institution - 069
Westmead, New South Wales, 2145
Local Institution
Westmead, New South Wales, 2145

Other trials in Australia

Brazil10 sites

Local Institution - 0020
Campinas, 13083-970
Local Institution
Campinas, 13083-970
Local Institution - 0021
Curitiba, Paraná, 80060-900
Local Institution
Curitiba, Paraná, 80060-900
Local Institution - 0022
Porto Alegre, Rio Grande do Sul, 90035-003
Local Institution
Porto Alegre, Rio Grande do Sul, 90035-003
Local Institution - 0019
São Paulo, São Paulo, 04520-013
Local Institution - 0039
São Paulo, 01401-000
Local Institution
São Paulo, 01401-000
Local Institution
São Paulo, 04023-062

Other trials in Brazil

Italy10 sites

Local Institution - 038
Bologna, 40138
Local Institution
Bologna, 40138
Local Institution - 006
Monza, 20900
Local Institution
Monza (MB), 20900
Local Institution - 070
Roma, 00161
Local Institution
Roma, 00161
Local Institution - 0059
Roma, 00165
Local Institution
Roma, 00165
Local Institution - 015
Torino, 10126
Local Institution
Torino, 10126

Other trials in Italy

South Africa8 sites

Local Institution - 0055
Bloemfontein, Free State, 9301
Local Institution
Bloemfontein, Free State, 9301
Local Institution - 0057
Cape Town, Western Cape, 7925
Local Institution
Cape Town, Western Cape, 7925
Local Institution - 058
Pretoria, Gauteng, 0001
Local Institution
Pretoria, Gauteng, 0001
Local Institution - 062
Tygerberg, Western Cape, 7505
Local Institution
Tygerberg, Western Cape, 7505

Other trials in South Africa

Argentina6 sites

Local Institution - 0043
Bunos Aires, Buenos Aires, 1425
Local Institution
Bunos Aires, Buenos Aires, 1425
Local Institution - 0042
Córdoba, 5016
Local Institution
Córdoba, 5016
Hospital Nacional Profesor Alejandro Posadas
El Palomar, Buenos Aires, 1684
Local Institution - 0049
El Palomar, Buenos Aires, 1684

Other trials in Argentina

Russia6 sites

Local Institution - 0017
Moscow, 115478
Local Institution
Moscow, 115478
Local Institution - 0023
Moscow, 117198
Local Institution
Moscow, 117198
Local Institution - 0018
Saint Petersburg, 197022
Local Institution
Saint Petersburg, 197022

Other trials in Russia

United Kingdom6 sites

Local Institution - 0008
Birmingham, West Midlands, B4 6NH
Local Institution
Birmingham, West Midlands, B4 6NH
Local Institution - 0016
Glasgow, Central, G3 8SJ
Local Institution
Glasgow, Central, G3 8SJ
Local Institution - 0009
Sutton, Surrey, SM2 5PT
Local Institution
Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Germany4 sites

Local Institution - 075
Frankfurt, 60590
Local Institution
Frankfurt, 60590
Local Institution - 0074
Hanover, 30625
Local Institution
Hanover, 30625

Other trials in Germany

South Korea4 sites

Local Institution - 0092
Seoul, 05505
Local Institution
Seoul, 05505
Local Institution - 0091
Seoul, 137-701
Local Institution
Seoul, 137-701

Other trials in South Korea

Netherlands3 sites

Local Institution - 0007
Rotterdam, 3015 GJ
Local Institution
Rotterdam, 3015 GJ
Local Institution - 0099
Utrecht, 3584 CS

Other trials in Netherlands

Romania3 sites

Local Institution - 0095
Bucharest, 022322
Local Institution
Bucharest, 022322
Local Institution - 0097
Sector 2, 022328

Other trials in Romania

Singapore2 sites

Local Institution - 0071
Singapore, 119074
Local Institution
Singapore, 119228

Other trials in Singapore

About this study

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

Conditions: Leukemia
Being tested: Dasatinib
Keywords: Leukemia, Pediatric
Medical subject headings: Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DasatinibDrug
Also called Sprycel (BMS-354825)

Study groups in NCT00777036
Study group	Role	What they receive
Cohort 1: Imatinib-resistant/intolerant CP-CML	Experimental	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 Receives: Drug: Dasatinib
Cohort 2: Ph+ALL or AP- or BP-CML	Experimental	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 Receives: Drug: Dasatinib
Cohort 3: Newly diagnosed, treatment naïve CP-CML	Experimental	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 Receives: Drug: Dasatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
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.
Measured: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
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.
Measured: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)

Secondary outcomes (18)

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.
Measured: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
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.
Measured: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
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)
Measured: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
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)
Measured: From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)
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)
Measured: From first day criteria are met for MCyR until the date PD is reported or death (assessed up to September 2016, approximately 90 months)
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)
Measured: From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)
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)
Measured: From first day criteria are met for CCyR until the date of progressive disease or death (assessed up to September 2016, approximately 90 months)
Progression-Free Survival (PFS)
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.
Measured: 174 Months
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.
Measured: From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)
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.
Measured: From first day criteria are met for CHR until date of disease progression or death (assessed up to September 2016, approximately 90 months)
Disease-Free Survival
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).
Measured: 168 Months
Overall Survival (OS)
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.
Measured: 174 Months
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.
Measured: From date of first treatment to date of MMR (assessed up to Jan 2025, approximately 15 years and 10 months)
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.
Measured: From date of first treatment to date of CMR (assessed up to Jan 2025, approximately 15 years and 10 months)
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.
Measured: 24 months
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.
Measured: 24 months
Major Molecular Response (MMR) Rate up to 7.5 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.
Measured: 90 months
Complete Molecular Response (CMR) Rate up to 7.5 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.
Measured: 90 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 200927 Jan 2025

First posted22 Oct 2008 (estimated)
Study start20 Mar 2009
Primary completion1 Sep 2016
Study completion27 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for LeukemiaStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00777036
Sponsor's protocol ID: CA180-226
Other IDs: 2008-002260-33, 2008
Status last verified: Aug 2025
First submitted: 21 Oct 2008
Last updated: 29 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 29498925

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00777036
Acronym / sponsor ID: CA180-226
Conditions: Leukemia
Keywords: Leukemia, Pediatric
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 20 Mar 2009 (actual)
Primary completion: 1 Sep 2016 (actual)
Study completion: 27 Jan 2025 (actual)
First posted: 22 Oct 2008 (estimated)
Results: Posted 5 Jan 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Cohort 1: Imatinib-resistant/intolerant CP-CML	Experimental	Drug: DasatinibDasatinib 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
Cohort 2: Ph+ALL or AP- or BP-CML	Experimental	Drug: DasatinibDasatinib 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
Cohort 3: Newly diagnosed, treatment naïve CP-CML	Experimental	Drug: DasatinibDasatinib 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

Who may qualify

Ages: 1 day to 18 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (12 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DasatinibAlso: Sprycel (BMS-354825)	Drug	Cohort 1: Imatinib-resistant/intolerant CP-CML, Cohort 2: Ph+ALL or AP- or BP-CML, Cohort 3: Newly diagnosed, treatment naïve CP-CML

Primary outcome

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)
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
Time frame: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
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
Time frame: From first dose of study therapy until 30 days after last dose (Assessed up to September 2016, approximately 90 months)
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.

18 secondary outcomes

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)
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)
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)
Time to Major Cytogenetic Response (MCyR)
Time frame: From first dose until MCyR criteria are met (assessed up to September 2016, approximately 90 months)
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)
Time to Complete Cytogenetic Response (CCyR)
Time frame: From first dose until CCyR criteria are met, assessed up to September 2016 (approximately 90 months)
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)
Progression-Free Survival (PFS)
Time frame: 174 Months
Time to Complete Hematologic Response (CHR)
Time frame: From first dose until CHR criteria are met, assessed up to September 2016 (approximately 90 months)
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)
Disease-Free Survival
Time frame: 168 Months
Overall Survival (OS)
Time frame: 174 Months
Major Molecular Response (MMR) Rate
Time frame: From date of first treatment to date of MMR (assessed up to Jan 2025, approximately 15 years and 10 months)
Complete Molecular Response (CMR) Rate
Time frame: From date of first treatment to date of CMR (assessed up to Jan 2025, approximately 15 years and 10 months)
Major Cytogenetic Response (MCyR) Rate up to 2 Years
Time frame: 24 months
Complete Cytogenetic Response (CCyR) Rate up to 2 Years
Time frame: 24 months
Major Molecular Response (MMR) Rate up to 7.5 Years
Time frame: 90 months
Complete Molecular Response (CMR) Rate up to 7.5 Years
Time frame: 90 months

Results and safety

Results posted to the registry on 5 Jan 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 1	29	0
Cohort 2	17	0
Cohort 3	84	0
PK Sub-Study	0	0

Primary outcome: 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). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort 1 n = 29
Value	89.7 (72.6 to 97.8)

Population analysed: Primary efficacy endpoint pre-specified only for participants treated in Cohort 1

Primary outcome: 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). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort 2 n = 17
Value	29.4 (10.3 to 56.0)

Population analysed: Primary efficacy endpoint pre-specified only for participants treated in Cohort 2

Primary outcome: 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). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Cohort 3 n = 84
Value	94.0 (86.7 to 98.0)

Population analysed: Primary efficacy endpoint pre-specified only for participants treated in Cohort 3

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were assessed for All-Cause Mortality, Serious adverse events (SAEs) and Other adverse events (AEs) in all treated participants (up to approximately 14 years 6 months). The participants who crossed over from Cohort 3 to PK Sub-study are accounted for in both arms. PK Sub-study only for the duration of the PK Sub-study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1	16 of 29 (55.2%)	27 of 29 (93.1%)	1 of 29
Cohort 2: BP-CML Only	7 of 8 (87.5%)	7 of 8 (87.5%)	4 of 8
Cohort 2: Ph + ALL Only	6 of 9 (66.7%)	9 of 9 (100%)	7 of 9
Cohort 3a	21 of 51 (41.2%)	50 of 51 (98%)	0 of 51
Cohort 3b	12 of 33 (36.4%)	33 of 33 (100%)	0 of 33
PK Sub-Study	0 of 7 (0%)	0 of 7 (0%)	0 of 7

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29498925Gore 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.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

174 sites in 18 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib in people with Leukemia, run by Bristol-Myers Squibb at 174 sites in 18 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 174 sites in United States, India, Canada, Mexico, Spain and 13 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jan 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00777036, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.