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Clinical Trials (PDQ®)

A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase CML or With Ph+ Leukemias Resistant or Intolerant to Imatinib

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IITreatmentActive1 to 21Pharmaceutical / IndustryCA180-226
2008-002260-33, NCT00777036

Trial Description

Summary

The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL), accelerated or blast phases CML who relapse after imatinib or who are resistant or intolerant to imatinib. The side effects of this oral investigational drug in children and adolescents will be evaluated

Further Study Information

Cohort 2 is closed to enrollment

Eligibility Criteria

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

Inclusion Criteria:

  • CP-CML who prove resistant or intolerant to imatinib (cohort #1)
  • Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (cohort #2)
  • Newly diagnosed, treatment naive CP-CML (cohort #3)
  • Lansky or Karnofsky scale >50
  • Life expectancy ≥12 weeks
  • Adequate hepatic and renal function
  • Written informed consent

Exclusion Criteria:

  • Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation
  • Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease)
  • Isolated extramedullary disease
  • Prior therapy with Dasatinib

Trial Contact Information

Trial Lead Organizations/Sponsors

Bristol-Myers Squibb Company - New York

Bristol-Myers SquibbStudy Director

Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
  Email: Clinical.Trials@bms.com

Trial Sites

U.S.A.
Arizona
  Phoenix
 Phoenix Children's Hospital
 Jessica Boklan, Site 005 Ph: 602-546-5004
California
  Long Beach
 Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
 Amanda Termuhlen, Site 001 Ph: 562-933-8621
  Orange
 Children's Hospital of Orange County
 Ivan Kirov, Site 024 Ph: 714-516-4203
Colorado
  Aurora
 Children's Hospital Colorado Center for Cancer and Blood Disorders
 Lia Gore, Site 004 Ph: 720-777-2879
Georgia
  Atlanta
 Aflac Cancer Center & Blood Disorders Service
 Todd M Cooper, Site 047 Ph: 404-785-3535
Illinois
  Chicago
 Ann and Robert H. Lurie Children's Hospital of Chicago
 Nobuko Hijiya, Site 072 Ph: 773-880-3443
Massachusetts
  Boston
 Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
 Andrew Place, Site 040
New York
  New York
 Memorial Sloan-Kettering Cancer Center
 Neerav Shukla, Site 061 Ph: 212-639-5158
 NYU Cancer Institute at New York University Medical Center
 Linda Granowetter, Site 063
Oregon
  Portland
 Knight Cancer Institute at Oregon Health and Science University
 Linda Stork, Site 002 Ph: 503-494-3358
Pennsylvania
  Philadelphia
 Children's Hospital of Philadelphia
 Richard Aplenc, Site 014 Ph: 267-426-9293
  Pittsburgh
 Children's Hospital of Pittsburgh of UPMC
 A. Kim Ritchey, Site 003 Ph: 412-692-6815
Texas
  Houston
 Texas Children's Cancer Center and Hematology Service at Texas Children's Hospital
 Karen Rabin, Site 048 Ph: 832-824-6835
Argentina
  Cordoba
 Local Institution
 Site 042
Buenos Aires
  Bunos Aires
 Local Institution
 Site 043
  El Palomar
 Local Institution
 Site 049
Australia
New South Wales
  Randwick
 Local Institution
 Site 065
  Westmead
 Local Institution
 Site 069
Queensland
  Herston
 Local Institution
 Site 064
South Australia
  North Adelaide
 Local Institution
 Site 067
Victoria
  Parkville
 Local Institution
 Site 066
Brazil
  Campinas
 Local Institution
 Site 020
  Curitiba
 Local Institution
 Site 021
  Porto Alegre
 Local Institution
 Site 022
  Sao Paulo
 Local Institution
 Site 019
 Site 039
Canada
Alberta
  Calgary
 Alberta Children's Hospital
 Aru Narendran, Site 079 Ph: 403-210-6418
  Edmonton
 Stollery Children'S Hospital
 Sunil Desai, Site 078 Ph: 780-407-8790
British Columbia
  Vancouver
 Children's and Women's Hospital of British Columbia
 Kirk Schultz, Site 077 Ph: 604-875-2345 Ext.5975
Nova Scotia
  Halifax
 IWK Health Centre
 Mark L Bernstein, Site 073 Ph: 902-470-8669
Ontario
  Ottawa
 Children's Hospital of Eastern Ontario
 Donna Johnston, Site 086 Ph: 613-737-7600 Ext.3783
  Toronto
 Hospital for Sick Children
 Sylvain Baruchel, Site 076 Ph: 416-813-5861
Quebec
  Montreal
 Chu Ste-Justine
 Yvan Samson, Site 080 Ph: 514-345-4969
Germany
  Frankfurt
 Local Institution
 Site 075
  Hannover
 Local Institution
 Site 074
India
  Bangalore
 Local Institution
 Site 088
  Kolkatta
 Local Institution
 Site 082
  Mumbai
 Local Institution
 Site 085
  Navrangpura, Ahmedabad
 Local Institution
 Site 089
  Pune
 Local Institution
 Site 094
  Trivandrum
 Local Institution
 Site 084
  Vellore
 Local Institution
 Site 087
Tamil Nadu
  Madurai
 Local Institution
 Site 093
Italy
  Bologna
 Local Institution
 Site 038
  Monza (mi)
 Local Institution
 Site 006
  Roma
 Local Institution
 Site 059
 Site 070
  Torino
 Local Institution
 Site 015
Mexico
  Df
 Local Institution
 Site 051
  Mexico
 Local Institution
 Site 053
  Mexico, D. F.
 Local Institution
 Site 052
  Monterrey
 Local Institution
 Site 050
  Monterrey, N.l.
 Local Institution
 Site 060
Jalisco
  Guadalajara
 Local Institution
 Site 054
Netherlands
  Rotterdam
 Local Institution
 Site 007
Republic of Korea
  Seoul
 Local Institution
 Site 091
 Site 092
Republic of South Africa
  Bloemfontein
 Local Institution
 Site 055
  Cape Town
 Local Institution
 Site 057
  Pretoria
 Local Institution
 Site 058
Romania
  Bucharest
 Local Institution
 Site 095
Russia
  Moscow
 Local Institution
 Site 017
 Site 023
  Saint-petersburg
 Local Institution
 Site 018
Spain
  Barcelona
 Local Institution
 Site 013
 Site 012
  Madrid
 Local Institution
 Site 011
 Site 010
  Malaga
 Local Institution
 Site 041
  Valencia
 Local Institution
 Site 033
United Kingdom
  Birmingham
 Local Institution
 Site 008
  Glasgow
 Local Institution
 Site 016
  Sutton
 Local Institution
 Site 009

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00777036
ClinicalTrials.gov processed this data on September 16, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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