Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

November 8, 2021 updated by: Bristol-Myers Squibb

A Phase 2 Multi-Center, Historically Controlled Study of Dasatinib Added to Standard Chemotherapy in Pediatric Patients With Newly Diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

The purpose of this study is to determine whether Dasatinib when added to standard chemotherapy is effective and safe in the treatment of pediatric philadelphia chromosome positive acute lymphoblastic leukemia

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
106

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Sth Brisbane, Queensland, Australia, 4101
        • Local Institution
    • Victoria
      • Parkville, Victoria, Australia, 3052
        • Local Institution
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Local Institution
      • Ottawa, Ontario, Canada, K1H 8L1
        • Children's Hospital of Eastern Ontario
    • Quebec
      • Montreal, Quebec, Canada, H3T 1C5
        • CHU Ste-Justine
      • Montreal, Quebec, Canada, H4A 3J1
        • The Montreal Children's Hospital of the MUHC
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Local Institution
  • Italy
      • Bologna, Italy, 40138
        • Local Institution
      • Cagliari, Italy, 09121
        • Local Institution
      • Catania, Italy, 95123
        • Local Institution
      • Firenze, Italy, 50139
        • Local Institution
      • Genova, Italy, 16147
        • Local Institution
      • Monza, Italy, 20900
        • Local Institution
      • Napoli, Italy, 80123
        • Local Institution
      • Palermo, Italy, 90134
        • Local Institution
      • Roma, Italy, 00161
        • Local Institution
      • Roma, Italy, 00165
        • Local Institution
      • Torino, Italy, 10126
        • Local Institution
      • Trieste, Italy, 34137
        • Local Institution
  • Puerto Rico
      • San Juan, Puerto Rico, 00912
        • Local Institution
  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Local Institution
    • Avon
      • Bristol, Avon, United Kingdom, BS2 8BJ
        • Local Institution
    • Glamorgan
      • Cardiff, Glamorgan, United Kingdom, CF14 4XW
        • Local Institution
    • Grampian
      • Aberdeen, Grampian, United Kingdom, AB25 2ZG
        • Local Institution
    • Greater London
      • London, Greater London, United Kingdom, WC1N3JH
        • Local Institution
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M27 4HA
        • Local Institution
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO9 4XY
        • Local Institution
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G3 8SJ
        • Local Institution
    • Lothian
      • Edinburgh, Lothian, United Kingdom, EH9 1LF
        • Local Institution
    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L12 2AP
        • Local Institution
    • North Yorkshire
      • Leeds, North Yorkshire, United Kingdom, LS1 3EX
        • Local Institution
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
        • Local Institution
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX 39DU
        • Local Institution
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2TH
        • Local Institution
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Local Institution
    • Tyne And Wear
      • Newcastle-upon-tyne, Tyne And Wear, United Kingdom, NE1 4LP
        • Local Institution
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B4 6NH
        • Local Institution
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
        • University of Arkansas for Medical Sciences
    • California
      • Loma Linda, California, United States, 92350
        • Antranik Agop Bedros
      • Long Beach, California, United States, 90806
        • Miller Children's and Women Hospital
      • Los Angeles, California, United States, 90027
        • Southern California Permanente Medical Group
      • Los Angeles, California, United States, 90027
        • Children'S Hospital Of L.A.
      • Madera, California, United States, 93636
        • Valley Children's Hospital
      • Orange, California, United States, 92868
        • Children's Hospital of Orange County
      • Palo Alto, California, United States, 94304
        • Lpch & Sumc
      • Roseville, California, United States, 95661
        • Kaiser Medical Center
      • San Francisco, California, United States, 94143-0106
        • Ucsf - Hematology/Oncology
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Connecticut
      • Hartford, Connecticut, United States, 06106
        • Connecticut Children's Medical Center
    • Delaware
      • Wilmington, Delaware, United States, 19803
        • A. I. Dupont Hospital For Children
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Children's National Medical Center
    • Florida
      • Fort Myers, Florida, United States, 33908
        • Lee Memorial Health System
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Jacksonville, Florida, United States, 32207
        • Nemours Children's Clinic
      • Orlando, Florida, United States, 32806
        • MD Anderson Cancer Center Orlando
      • Orlando, Florida, United States, 32827
        • Nemours Childrens Hospital
      • Saint Petersburg, Florida, United States, 33629
        • All Children's Hospital
      • Tampa, Florida, United States, 33607
        • St. Joseph's Children's Hospital
      • West Palm Beach, Florida, United States, 33407
        • St. Mary's
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta
    • Hawaii
      • Honolulu, Hawaii, United States, 96826
        • Kapiolani Medical Center For Women & Children
    • Idaho
      • Boise, Idaho, United States, 83712
        • Mountain States Tumor Institute
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H Lurie Children's Hospital of Chicago
      • Maywood, Illinois, United States, 60153
        • Loyola University Medical Center
      • Springfield, Illinois, United States, 62794-9635
        • Southern Illinois University School of Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Children'S Center For Cancer And Blood Diseases
      • Indianapolis, Indiana, United States, 46202-5225
        • James Whitcomb Riley Hospital For Children
    • Kentucky
      • Lexington, Kentucky, United States, 40536-0284
        • University of Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Children's Hospital
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21231
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
      • Worcester, Massachusetts, United States, 01655
        • UMass Memorial Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Children's Hospital of Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Helen DeVos Children's Hospital
      • Lansing, Michigan, United States, 48912
        • Michigan State University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Childrens Hospitals and Clinics of Minnesota
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Univ of Mississippi Med Ctr
    • Missouri
      • Columbia, Missouri, United States, 65212
        • University of Missouri Health Care
      • Kansas City, Missouri, United States, 64108
        • Children's Mercy Hospital and Clinics
      • Saint Louis, Missouri, United States, 63110
        • Washington University Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Children's Specialty Center of Nevada
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Hackensack University Medical Center
      • Morristown, New Jersey, United States, 07962
        • Goryeb Children's Hospital
      • New Brunswick, New Jersey, United States, 08901
        • The Cancer Institute of New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Israel Medical Center
      • Paterson, New Jersey, United States, 07503
        • St. Joseph's Regional Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • University of New Mexico
    • New York
      • New York, New York, United States, 10016
        • New York University
      • New York, New York, United States, 10032
        • The Herbert Irving Pavilion
      • New York, New York, United States, 10065
        • New York Presbyterian/Weill Cornell
      • Syracuse, New York, United States, 13210
        • Suny Upstate Medical University
      • Valhalla, New York, United States, 10595
        • New York Medical College
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Levine Children's Hospital
      • Winston-Salem, North Carolina, United States, 27157-1081
        • Wake Forest University
    • Ohio
      • Cincinnati, Ohio, United States, 45229-3039
        • Cincinnati Children's Hospital Medical Center
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
      • Dayton, Ohio, United States, 45404-1815
        • The Children's Medical Center of Dayton
      • Toledo, Ohio, United States, 43608
        • Mercy Children's Hospital
      • Toledo, Ohio, United States, 43606
        • The Toledo Children'S Hospital
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Oregon
      • Portland, Oregon, United States, 97227
        • Legacy Emanuel Hospital & Health Center
      • Portland, Oregon, United States, 97239
        • Oregon Health & Sci Univ
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-1320
        • Geisinger Medical Center
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Philadelphia, Pennsylvania, United States, 19104-4318
        • Children's Hospital of Philadelphia
      • Pittsburgh, Pennsylvania, United States, 15224
        • Children's Hospital of Pittsburgh of UPMC
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • East Tennessee Children'S Hosp
      • Nashville, Tennessee, United States, 37232-6310
        • Vanderbilt University
    • Texas
      • Austin, Texas, United States, 78723
        • Dell Children's Medical Center of Central Texas
      • Corpus Christi, Texas, United States, 78411
        • Driscoll Children's Hospital
      • Dallas, Texas, United States, 75390-9063
        • UT Southwestern
      • Fort Worth, Texas, United States, 76104
        • Cook Children'S Hem/Onc Center
      • Houston, Texas, United States, 77030
        • Texas Children's Cancer Center
      • Temple, Texas, United States, 76508
        • Scott & White - McLane Children's Specialty Clinic
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Medical Center
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Inova Pediatric Specialty Center Ii
      • Norfolk, Virginia, United States, 23507
        • Children'S Hosp-Kings Daughter
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54301
        • St Vincent Hospital
      • Madison, Wisconsin, United States, 53705-2275
        • Kenneth Desantes, Md
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

  • Newly diagnosed Philadelphia chromosome positive Acute Lymphoblastic Leukemia (ALL)
  • Age >1 year and < less than 18 years old
  • Induction chemotherapy ≤ 14 days according to institutional standard of care
  • Adequate liver, renal and cardiac function

Exclusion Criteria:

  • Prior treatment with a Oncogene fusion protein (BCR-ABL) inhibitor
  • Extramedullary involvement of the testicles
  • Active systemic bacterial, fungal or viral infection
  • Down syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Dasatinib
Drug: Dasatinib
Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
Other Names:
  • Sprycel

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
3-year Event-free Survival (EFS) Rate
Time Frame: From first dose to 3 years following first dose

3-year EFS rate is defined as the percentage of participants without event after 3 years since the start of study treatment.

Events for EFS are defined as ANY first one of the following:

  • Lack of complete response in bone marrow
  • Relapse at any site
  • Development of second malignant neoplasm
  • Death from any cause
From first dose to 3 years following first dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Adverse Events
Time Frame: From first dose to 100 days following last dose (up to approximately 23 months)
Number of participants experiencing different types of all causality all grade adverse events
From first dose to 100 days following last dose (up to approximately 23 months)
Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)
Time Frame: From first dose to 3 years or 5 years following first dose
Overall estimation of the EFS of dasatinib plus chemotherapy was performed utilizing the Kaplan-Meier (KM) Product Limit method. The 3-year and 5-year EFS rates were computed with the corresponding 95% CI's using Greenwood's formula. Analyses of EFS included KM plots with number of patients at risk. Participants who neither relapse nor die or who are lost to follow-up were censored on the date of their last bone marrow, CSF assessment or physical exam, whichever occurred last.
From first dose to 3 years or 5 years following first dose
Complete Remission Rate
Time Frame: From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)
Complete Remission rate is defined as the percentage of participants achieving a complete remission, i.e. < 5% lymphoblasts in bone marrow and in CSF, with no evidence of other extramedullary disease. Complete remission will be assessed at the end of Induction IA, end of induction IB and end of the consolidation period for all treated participants.
From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)
Percentage of Participants Negative for Minimal Residual Disease (MRD)
Time Frame: From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)
MRD was by real-time qPCR for clone-specific immunoglobulin and T-cell receptor gene rearrangements (IG/TCR). Participants were declared as MRD negative if the MRD level is undetectable providing the assay lower limit of quantification is at least 0.1%
From first dose to End of Induction Period Ia (up to 5 weeks) or Ib (up to 9 weeks) or End of Consolidation Period (up to 22 weeks)
Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse
Time Frame: At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years)
A BCR-ABL mutation is defined as the presence of a detectable amino acid substitution in the ABL kinase domain, assessed by Real-time quantitative PCR.
At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bristol-Myers Squibb

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Oncology Group
EsPhALL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 25, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 26, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CA180-372
  • 2011-001123-20 (EudraCT Number)
  • AALL1122 (Other Identifier: COG)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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