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Leukemia, PediatricPhase 2NCT01460160

Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

A Phase 2 study testing Dasatinib in people with Leukemia, Pediatric, run by Bristol-Myers Squibb at 128 sites in 6 countries.

Completed

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

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 1 year to 17 years
Conditions the study is for
Leukemia, Pediatric
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
106 participants
Where
128 sitesin 6 countries
Study dates
13 Apr 2012to 1 Jun 2021
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 year to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

128 sites in 6 countries.

128 sites in 6 countries

United States88 sites

  • University Of New Mexico

    Albuquerque, New Mexico, 87131-0001

  • Children's Healthcare Of Atlanta

    Atlanta, Georgia, 30322

  • Children'S Hospital Colorado

    Aurora, Colorado, 80045

  • Dell Children'S Medical Center Of Central Texas

    Austin, Texas, 78723

  • Sinai Hospital Of Baltimore

    Baltimore, Maryland, 21215

  • Johns Hopkins University

    Baltimore, Maryland, 21231

  • University Of Alabama At Birmingham

    Birmingham, Alabama, 35233

  • Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Levine Children's Hospital

    Charlotte, North Carolina, 28203

  • Ann & Robert H Lurie Children's Hospital Of Chicago

    Chicago, Illinois, 60611

  • Cincinnati Children'S Hospital Medical Center

    Cincinnati, Ohio, 45229-3039

  • University Of Missouri Health Care

    Columbia, Missouri, 65212

  • Nationwide Children'S Hospital

    Columbus, Ohio, 43205

  • Driscoll Children'S Hospital

    Corpus Christi, Texas, 78411

  • Ut Southwestern

    Dallas, Texas, 75390-9063

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-1320

  • The Children'S Medical Center Of Dayton

    Dayton, Ohio, 45404-1815

  • Children'S Hospital Of Michigan

    Detroit, Michigan, 48201

  • Inova Pediatric Specialty Center Ii

    Fairfax, Virginia, 22031

  • Lee Memorial Health System

    Fort Myers, Florida, 33908

  • Cook Children'S Hem/Onc Center

    Fort Worth, Texas, 76104

  • University Of Florida

    Gainesville, Florida, 32610

  • Helen Devos Children'S Hospital

    Grand Rapids, Michigan, 49503

  • St Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Connecticut Children's Medical Center

    Hartford, Connecticut, 06106

  • Penn State Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Kapiolani Medical Center For Women & Children

    Honolulu, Hawaii, 96826

  • Texas Children'S Cancer Center

    Houston, Texas, 77030

  • James Whitcomb Riley Hospital For Children

    Indianapolis, Indiana, 46202-5225

  • Children'S Center For Cancer And Blood Diseases

    Indianapolis, Indiana, 46260

  • Univ Of Mississippi Med Ctr

    Jackson, Mississippi, 39216

  • Nemours Children'S Clinic

    Jacksonville, Florida, 32207

  • Children'S Mercy Hospital And Clinics

    Kansas City, Missouri, 64108

  • East Tennessee Children'S Hosp

    Knoxville, Tennessee, 37916

  • Michigan State University

    Lansing, Michigan, 48912

  • Children'S Specialty Center Of Nevada

    Las Vegas, Nevada, 89109

  • University Of Kentucky

    Lexington, Kentucky, 40536-0284

  • University Of Arkansas For Medical Sciences

    Little Rock, Arkansas, 72202

  • Antranik Agop Bedros

    Loma Linda, California, 92350

  • Miller Children's and Women Hospital

    Long Beach, California, 90806

  • Children'S Hospital Of L.A.

    Los Angeles, California, 90027

  • Southern California Permanente Medical Group

    Los Angeles, California, 90027

  • Norton Children's Hospital

    Louisville, Kentucky, 40202

  • Valley Children's Hospital

    Madera, California, 93636

  • Kenneth Desantes, Md

    Madison, Wisconsin, 53705-2275

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Childrens Hospitals And Clinics Of Minnesota

    Minneapolis, Minnesota, 55404

  • Goryeb Children'S Hospital

    Morristown, New Jersey, 07962

  • Vanderbilt University

    Nashville, Tennessee, 37232-6310

  • The Cancer Institute Of New Jersey

    New Brunswick, New Jersey, 08901

  • New York University

    New York, New York, 10016

  • The Herbert Irving Pavilion

    New York, New York, 10032

  • New York Presbyterian/Weill Cornell

    New York, New York, 10065

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Children'S Hosp-Kings Daughter

    Norfolk, Virginia, 23507

  • University Of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Children's Hospital of Orange County

    Orange, California, 92868

  • Md Anderson Cancer Center Orlando

    Orlando, Florida, 32806

  • Nemours Childrens Hospital

    Orlando, Florida, 32827

  • Lpch & Sumc

    Palo Alto, California, 94304

  • St. Joseph's Regional Medical Center

    Paterson, New Jersey, 07503

  • Children'S Hospital Of Philadelphia

    Philadelphia, Pennsylvania, 19104-4318

  • Phoenix Children'S Hospital/Ctr. For Cancer & Blood Ctr.

    Phoenix, Arizona, 85016

  • Children's Hospital Of Pittsburgh Of UPMC

    Pittsburgh, Pennsylvania, 15224

  • Legacy Emanuel Hospital & Health Center

    Portland, Oregon, 97227

  • Oregon Health & Sci Univ

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Kaiser Medical Center

    Roseville, California, 95661

  • Primary Children's Medical Center

    Salt Lake City, Utah, 84113

  • Ucsf - Hematology/Oncology

    San Francisco, California, 94143-0106

  • Seattle Children'S

    Seattle, Washington, 98105

  • Southern Illinois University School Of Medicine

    Springfield, Illinois, 62794-9635

  • Washington University Medical Center

    St Louis, Missouri, 63110

  • All Children'S Hospital

    St. Petersburg, Florida, 33629

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • St. Joseph's Children's Hospital

    Tampa, Florida, 33607

  • Scott & White - McLane Children's Specialty Clinic

    Temple, Texas, 76508

  • The Toledo Children'S Hospital

    Toledo, Ohio, 43606

  • Mercy Children's Hospital

    Toledo, Ohio, 43608

  • New York Medical College

    Valhalla, New York, 10595

  • Children'S National Medical Center

    Washington D.C., District of Columbia, 20010

  • St. Mary'S

    West Palm Beach, Florida, 33407

  • A. I. Dupont Hospital For Children

    Wilmington, Delaware, 19803

  • Wake Forest University

    Winston-Salem, North Carolina, 27157-1081

  • UMass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

United Kingdom17 sites

  • Local Institution

    Aberdeen, Grampian, AB25 2ZG

  • Local Institution

    Birmingham, West Midlands, B4 6NH

  • Local Institution

    Bristol, Avon, BS2 8BJ

  • Local Institution

    Cambridge, CB2 2QQ

  • Local Institution

    Cardiff, Glamorgan, CF14 4XW

  • Local Institution

    Edinburgh, Lothian, EH9 1LF

  • Local Institution

    Glasgow, Lanarkshire, G3 8SJ

  • Local Institution

    Leeds, North Yorkshire, LS1 3EX

  • Local Institution

    Liverpool, Merseyside, L12 2AP

  • Local Institution

    London, Greater London, WC1N3JH

  • Local Institution

    Manchester, Greater Manchester, M27 4HA

  • Local Institution

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP

  • Local Institution

    Nottingham, Nottinghamshire, NG7 2UH

  • Local Institution

    Oxford, Oxfordshire, OX 39DU

  • Local Institution

    Sheffield, South Yorkshire, S10 2TH

  • Local Institution

    Southampton, Hampshire, SO9 4XY

  • Local Institution

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

Italy12 sites

  • Local Institution

    Bologna, 40138

  • Local Institution

    Cagliari, 09121

  • Local Institution

    Catania, 95123

  • Local Institution

    Florence, 50139

  • Local Institution

    Genova, 16147

  • Local Institution

    Monza, 20900

  • Local Institution

    Naples, 80123

  • Local Institution

    Palermo, 90134

  • Local Institution

    Roma, 00161

  • Local Institution

    Roma, 00165

  • Local Institution

    Torino, 10126

  • Local Institution

    Trieste, 34137

Other trials in Italy

Canada7 sites

  • Alberta Children'S Hospital

    Calgary, Alberta, T3B 6A8

  • Stollery Children'S Hospital

    Edmonton, Alberta, T6G 2B7

  • Local Institution

    London, Ontario, N6A 5W9

  • Chu Ste-Justine

    Montreal, Quebec, H3T 1C5

  • The Montreal Children's Hospital of the MUHC

    Montreal, Quebec, H4A 3J1

  • Children'S Hospital Of Eastern Ontario

    Ottawa, Ontario, K1H 8L1

  • Local Institution

    Saskatoon, Saskatchewan, S7N 4H4

Other trials in Canada

Australia3 sites

  • Local Institution

    Nedlands, Western Australia, 6009

  • Local Institution

    Parkville, Victoria, 3052

  • Local Institution

    Sth Brisbane, Queensland, 4101

Other trials in Australia

Puerto Rico1 site

  • Local Institution

    San Juan, 00912

Other trials in Puerto Rico

About this study

Official title: 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

Being tested
Dasatinib
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

    Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity

Study groups in NCT01460160
Study groupRoleWhat they receive
Arm 1: DasatinibExperimentalNot described
Receives: Drug: Dasatinib

What is being measured

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

  1. 3-year Event-free Survival (EFS) Rate

    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

    Measured: From first dose to 3 years following first dose

Secondary outcomes (5)

  1. Number of Participants Experiencing Adverse Events

    Number of participants experiencing different types of all causality all grade adverse events

    Measured: From first dose to 100 days following last dose (up to approximately 23 months)

  2. Event-Free Survival (EFS) Rate (Kaplan-Meier Estimates)

    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.

    Measured: From first dose to 3 years or 5 years following first dose

  3. Complete Remission Rate

    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.

    Measured: 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)

  4. Percentage of Participants Negative for Minimal Residual Disease (MRD)

    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%

    Measured: 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)

  5. Percentage of Participants With BCR-ABL Mutations at Baseline and at Time of Disease Progression or Relapse

    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.

    Measured: At baseline (prior to start of study treatment) and at disease progression or relapse (up to approximately 3 years)

Timeline

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

  1. First posted26 Oct 2011 (estimated)
  2. Study start13 Apr 2012
  3. Primary completion28 May 2017
  4. Study completion1 Jun 2021

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01460160
Sponsor's protocol ID
CA180-372
Other IDs
2011-001123-20, AALL1122
Status last verified
Nov 2021
First submitted
25 Oct 2011
Last updated
8 Dec 2021
Data monitoring committee
Yes

Publications

  • Hunger SP, Tran TH, Saha V, Devidas M, Valsecchi MG, Gastier-Foster JM, Cazzaniga G, Reshmi SC, Borowitz MJ, Moorman AV, Heerema NA, Carroll AJ, Martin-Regueira P, Loh ML, Raetz EA, Schultz KR, Slayton WB, Cario G, Schrappe M, Silverman LB, Biondi A. Dasatinib with intensive chemotherapy in de novo paediatric Philadelphia chromosome-positive acute lymphoblastic leukaemia (CA180-372/COG AALL1122): a single-arm, multicentre, phase 2 trial. Lancet Haematol. 2023 Jul;10(7):e510-e520. doi: 10.1016/S2352-3026(23)00088-1.

    PubMed 37407142

  • Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available.

    PubMed 33242441

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dasatinib in people with Leukemia, Pediatric, run by Bristol-Myers Squibb at 128 sites in 6 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 4 inclusion and 4 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 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 128 sites in United States, United Kingdom, Italy, Canada, Australia and 1 more country. 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 21 Aug 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?

3-year Event-free Survival (EFS) Rate (time frame: From first dose to 3 years following first dose). 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 NCT01460160, which also lists 2 linked publications.

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 8 Dec 2021.

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