Study of Dasatinib in Children and Adolescents With Relapsed or Refractory Leukemia

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Leukemia

Treatments: Drug: Dasatinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00306202

Protocol ITCC 005

CA180-018

2005-002882-35 (EudraCT Number)

Details and patient eligibility

About

The purpose of this clinical research study was to establish a recommended phase 2 once daily (QD) dose of dasatinib and to assess the efficacy of the investigational drug for relapsed or refractory (resistant to previous treatment) leukemia in children and adolescents. The side effects that this oral investigational drug may have in children, and the levels of the drug in the blood, will be studied at different doses.

Enrollment: 63 patients

Sex: All

Ages: 12 months to 20 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:

• Ph-positive (Ph+) Chronic Myelogenous Leukemia in chronic, accelerated or blast phase or Ph+ acute lymphoblastic leukemia (ALL) with imatinib-resistant disease or intolerance to imatinib.
• Ph-negative acute leukemia in second or subsequent relapse
• Age >1 and <21 years
• Lansky or Karnofsky scale >60
• Life expectancy >3 weeks
• Adequate hepatic and renal function
• Written informed consent

Exclusion Criteria:

• Subjects for whom potentially-curative therapy was available, including electing immediate [ie, planned <45 days] stem-cell transplantation. Subjects in Stratum 1 were to have had an ongoing identical HLA donor search, and may have discontinued study if a donor became available.)
• Subjects with symptomatic central nervous system (CNS) disease (eg, convulsions due to their CNS disease).
• Subjects who had not recovered from acute toxicity of previous therapy.
• Clinically-significant disorder of platelet function (eg, von Willebrand's disease) or ongoing gastrointestinal bleeding.
• Serious uncontrolled medical disorder or active infection
• Uncontrolled or significant cardiovascular disease
• Use of any investigational agent or any other anticancer agent within 14 days prior to treatment start.
• Prior therapy with dasatinib
• Subjects taking medications that irreversibly inhibit platelet function or anticoagulants.
• Subjects taking certain medications that are accepted to have a risk of causing QTc prolongation.
• Women of Child Bearing Potential with a positive pregnancy test prior to study drug administration.
• Expected noncompliance, or unable to have regular follow-up due to psychologic, social, familial, or geographic reasons.
• Subjects who are compulsorily detained for legal reasons or treatment of either a psychiatric or physical (eg, infectious disease) illness must not be enrolled into this study.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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63 participants in 3 patient groups

Stratum 1 (Ph+ CP-CML)

Experimental group

Description:

Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP)

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Stratum 2/3 (Ph+ ALL or AP/BP-CML)

Experimental group

Description:

Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML)

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib

Stratum 4 (Ph- ALL/AML)

Experimental group

Description:

Participants with second or subsequent relapse of Ph- ALL or Ph- AML

Treatment:

Drug: Dasatinib

Drug: Dasatinib

Drug: Dasatinib