Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

Plain-language summary

This study evaluates the drug Dasatinib in children newly diagnosed with Philadelphia chromosome-positive Acute Lymphoblastic Leukemia (ALL). It included children aged 1-18 with no prior BCR-ABL inhibitor treatment. It was a Phase 2 study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Bristol-Myers Squibb

Intervention

Dasatinib

Start date

4/13/2012

Estimated completion

6/1/2021

Countries

United States, Australia, Canada, Italy, Puerto Rico, United Kingdom

Related genes

Locations

• Birmingham, United States
• Phoenix, United States
• Little Rock, United States
• Loma Linda, United States
• Long Beach, United States
• Los Angeles, United States
• Los Angeles, United States
• Madera, United States
• Orange, United States
• Palo Alto, United States
• Roseville, United States
• San Francisco, United States
• Aurora, United States
• Hartford, United States
• Wilmington, United States
• Washington D.C., United States
• Fort Myers, United States
• Gainesville, United States
• Jacksonville, United States
• Orlando, United States
• Orlando, United States
• St. Petersburg, United States
• Tampa, United States
• West Palm Beach, United States
• Atlanta, United States
• Honolulu, United States
• Boise, United States
• Chicago, United States
• Maywood, United States
• Springfield, United States
• Indianapolis, United States
• Indianapolis, United States
• Lexington, United States
• Louisville, United States
• Baltimore, United States
• Baltimore, United States
• Boston, United States
• Worcester, United States
• Detroit, United States
• Grand Rapids, United States

+88

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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