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Pediatric Philadelphia Positive Acute Lymphoblastic Leukemia

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Completed
Phase 2

Conditions

Leukemia, Pediatric

Treatments

Drug: Dasatinib

Study type

Interventional

Funder types

Other
NETWORK
Industry

Identifiers

NCT01460160
CA180-372
2011-001123-20 (EudraCT Number)
AALL1122 (Other Identifier)

Details and patient eligibility

About

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

Enrollment

106 patients

Sex

All

Ages

1 to 17 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

106 participants in 1 patient group

Arm 1: Dasatinib
Experimental group
Treatment:
Drug: Dasatinib

Trial documents
2

Trial contacts and locations

128

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Data sourced from clinicaltrials.gov

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