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Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

130 Participants Needed

Dasatinib for Pediatric Leukemia

Recruiting at 165 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Bristol-Myers Squibb

Must be taking: Dasatinib

Must not be taking: Proton pump inhibitors

Disqualifiers: Stem-cell transplant, CNS involvement, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Prior Safety DataThis treatment has passed at least one previous human trial

Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for children and adolescents with newly diagnosed chronic myeloid leukemia (CML) or Ph+ acute lymphoblastic leukemia (ALL) who are resistant or intolerant to imatinib. Participants must have a life expectancy of at least 12 weeks, good liver and kidney function, and provide written consent. They should not have symptomatic CNS involvement, prior dasatinib therapy, or be on certain other medications.

Inclusion Criteria

Life expectancy ≥12 weeks

Target Population for the PK substudy subjects must meet relevant inclusion criteria

I have CML and cannot tolerate or didn't respond to imatinib.

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Exclusion Criteria

Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria

I am not using proton pump inhibitors, H2 antagonists, or CYP3A4 modifiers.

My cancer is located outside the bone marrow.

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dasatinib therapy for a minimum of 24 months, with dosage adjusted based on body surface area

24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days after last dose

Long-term follow-up

Participants are followed yearly for survival for up to 5 years after treatment discontinuation

5 years

Treatment Details

Interventions

Dasatinib

Trial Overview The study tests the safety and effectiveness of dasatinib in young patients with various phases of CML or ALL who can't use imatinib. It includes three cohorts: those new to treatment, those resistant/intolerant to imatinib, and a pharmacokinetics substudy group analyzing drug levels in the body.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Cohort 3: Newly diagnosed, treatment naïve CP-CMLExperimental Treatment1 Intervention

Dasatinib 60 mg/m² tablet QD \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² PFOS QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

Group II: Cohort 2: Ph+ALL or AP- or BP-CMLExperimental Treatment1 Intervention

Dasatinib 80 mg/m² tablet QD \[with a maximum dose of 140 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 96 mg/m² PFOS QD \[with a maximum dose of 170 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

Group III: Cohort 1: Imatinib-resistant/intolerant CP-CMLExperimental Treatment1 Intervention

Dasatinib 60 mg/m² tablet every day (QD) \[with a maximum dose of 100 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit OR Dasatinib 72 mg/m² powder for oral suspension (PFOS) QD \[with a maximum dose of 120 mg QD for subjects with high BSA\] for minimum of 24 months, may continue as long as deriving clinical benefit

Dasatinib is already approved in United States, European Union, Canada for the following indications: