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



Status:Active, not recruiting
Conditions:Blood Cancer, Leukemia
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 18
Updated:1/31/2018
Start Date:February 19, 2009
End Date:September 23, 2021

Use our guide to learn which trials are right for you!

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

Cohort 2 was closed early to enrollment based on insufficient treatment response and poor
enrollment

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
We found this trial at
16
sites
1201 W La Veta Ave
Orange, California 92868
(714) 997-3000
Children's Hospital of Orange County For more than 45 years, CHOC Children’s has been steadfastly...
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Orange, CA
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South 34th Street
Philadelphia, Pennsylvania 19104
 215-590-1000
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Philadelphia, PA
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3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Portland, OR
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Atlanta, GA
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Aurora, Colorado 80045
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Aurora, CO
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Boston, Massachusetts 02115
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Boston, MA
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Bunos Aires, Buenos Aires
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Bunos Aires,
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Chicago, Illinois 60611
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Chicago, IL
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Houston, Texas 77030
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Houston, TX
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Houston, Texas 77030
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Houston, TX
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Long Beach, California 90806
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Long Beach, CA
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1275 York Ave
New York, New York 10021
(212) 639-2000
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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New York, NY
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New York, New York 10016
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New York, NY
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Phoenix, AZ
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3414 Fifth Avenue
Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Seattle, Washington 98115
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Seattle, WA
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