AzTrials
AzTrials

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.

Official record
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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.

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

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

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 groupRoleWhat they receive
Cohort 1: Imatinib-resistant/intolerant CP-CMLExperimentalDasatinib 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-CMLExperimentalDasatinib 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-CMLExperimentalDasatinib 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.

  1. 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)

  2. 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)

  3. 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)

  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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)

  6. 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)

  7. 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)

  8. 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

  9. 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)

  10. 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)

  11. 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

  12. 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

  13. 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)

  14. 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)

  15. 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

  16. 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

  17. 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

  18. 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.

  1. First posted22 Oct 2008 (estimated)
  2. Study start20 Mar 2009
  3. Primary completion1 Sep 2016
  4. Study completion27 Jan 2025

Resources

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
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

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.

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