Dasatinib for Pediatric Leukemia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether dasatinib, an oral medication, is safe and effective for children and teens with certain types of leukemia. It targets those newly diagnosed with chronic myeloid leukemia (CML) or those with specific leukemia types who have stopped responding to or cannot tolerate imatinib, a current treatment. Participants should have CML or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) and have experienced issues with imatinib treatment, such as resistance or side effects. As a Phase 2 trial, it measures how well the treatment works in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that participants in a specific part of the study cannot use certain stomach acid reducers and drugs that affect liver enzymes. It's best to discuss your current medications with the trial team.
Is there any evidence suggesting that dasatinib is likely to be safe for children and adolescents?
Research shows that dasatinib has undergone safety testing in children with leukemia. In studies involving children with chronic myeloid leukemia (CML), dasatinib has proven to be a safe and effective treatment. However, serious side effects can occur, such as severe bleeding, including in the brain, which can be life-threatening.
Despite these risks, real-world safety data indicate that children generally tolerate dasatinib well. The largest study to date in children with chronic phase CML supports its safety and effectiveness. Potential participants should discuss the possible benefits and risks with their healthcare provider to make an informed decision.12345Why do researchers think this study treatment might be promising for leukemia?
Researchers are excited about dasatinib for pediatric leukemia because it offers a targeted approach that differs from traditional chemotherapies. Unlike standard treatments that broadly attack cancer cells, dasatinib specifically targets proteins involved in the growth of leukemia cells, potentially leading to more effective outcomes with fewer side effects. This precision makes dasatinib particularly promising for treating children with forms of leukemia that are resistant or intolerant to other therapies. Additionally, its flexibility in dosing, catering to different body sizes, allows for personalized treatment, which is crucial in pediatric care.
What evidence suggests that dasatinib could be an effective treatment for pediatric leukemia?
Research has shown that dasatinib effectively treats chronic myeloid leukemia (CML) in children. In studies, 78% of children with newly diagnosed CML experienced a significant drop in cancer markers within three months. Participants in this trial who are newly diagnosed and treatment-naïve will receive dasatinib as part of Cohort 3. Additionally, 93% of these children remained disease-free after four years. For children who did not respond to imatinib, an earlier treatment, 78% did not see their disease worsen over four years. These participants will be part of Cohort 1, receiving dasatinib for imatinib-resistant/intolerant CP-CML. Dasatinib also shows promise for children with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL), although less information is available. Participants with Ph+ ALL or advanced phases of CML will be part of Cohort 2. Overall, dasatinib offers hope as a treatment for pediatric leukemia.36789
Who Is on the Research Team?
Bristol-Myers Squibb
Principal Investigator
Bristol-Myers Squibb
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dasatinib therapy for a minimum of 24 months, with dosage adjusted based on body surface area
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are followed yearly for survival for up to 5 years after treatment discontinuation
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
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
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
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:
- Chronic myeloid leukemia (CML)
- Acute lymphoblastic leukemia (ALL)
- Chronic myeloid leukemia (CML)
- Acute lymphoblastic leukemia (ALL)
- Chronic myeloid leukemia (CML)
- Acute lymphoblastic leukemia (ALL)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Bristol-Myers Squibb
Lead Sponsor
Christopher Boerner
Bristol-Myers Squibb
Chief Executive Officer since 2023
PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis
Deepak L. Bhatt
Bristol-Myers Squibb
Chief Medical Officer since 2024
MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania
Citations
SPRYCEL® (dasatinib) Pediatric Efficacy | HCP
SPRYCEL was evaluated in 97 pediatric patients with newly diagnosed or imatinib-resistant/ intolerant CP-CML in 2 studies.
Dasatinib in Pediatric Patients With Chronic Myeloid ...
Dasatinib is approved for treatment of adults and children with CML-CP. A phase I study determined suitable dosing for children with Philadelphia chromosome– ...
Dasatinib in the Management of Pediatric Patients With ...
In this manuscript, we will discuss the role of this drug in pediatric Ph+ALL, analyzing the available data published to date.
International pediatric CML expert panel recommendations
Phase II trial of hyper CVAD and dasatinib in patients with relapsed Philadelphia chromosome positive acute lymphoblastic leukemia or blast ...
Early, Durable Responses Seen with Sprycel (dasatinib) in ...
Cohort 2 evaluated Sprycel in pediatric patients with accelerated/blast phase CML or Philadelphia chromosome-positive acute lymphoblastic ...
SPRYCEL® (dasatinib) Pediatric Safety | HCP
SPRYCEL can cause serious and fatal bleeding. In all CML or Ph+ ALL clinical studies, Grade ≥3 central nervous system (CNS) hemorrhages, including fatalities, ...
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lymphoblastic-hub.com
lymphoblastic-hub.com/medical-information/dasatinib-real-world-safety-profiles-in-pediatric-patientsDasatinib real-world safety profiles in pediatric patients
A real-world study analyzing the safety data of dasatinib in pediatric patients with malignancies, including Philadelphia ...
SPRYCEL® (dasatinib) - Official Patient Website
SPRYCEL® (dasatinib) is used to treat adults and children 1 year of age and older with newly diagnosed Ph+ CML (Philadelphia chromosome-positive chronic ...
Safety profiles of dasatinib in pediatric patients: a real-world ...
This study provides a comprehensive evaluation of the safety profile of dasatinib in pediatric patients using real-world data from the FAERS ...
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