Clinical trial · Interventional
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
A Phase II Study of Dasatinib Therapy in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia or With Ph+ Leukemias Resistant or Intolerant to Imatinib
NCT00777036CI-TRIAL-00094295completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dasatinib | Drug | Dasatinib | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1: Imatinib-resistant/intolerant CP-CML
- description
- 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
- interventionNames
- Drug: Dasatinib
- type
- EXPERIMENTAL
- label
- Cohort 2: Ph+ALL or AP- or BP-CML
- description
- 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
- interventionNames
- Drug: Dasatinib
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 18 Years
Show eligibility criteria text
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com. Inclusion Criteria: * CP-CML who prove resistant or intolerant to imatinib (Cohort 1) * Ph+ ALL, AP-CML, or BP-CML who are resistant or intolerant to or who relapse after imatinib therapy (Cohort 2) * Newly diagnosed, treatment naive CP-CML (Cohort 3) * Lansky or Karnofsky scale \>50 * Life expectancy ≥12 weeks * Adequate hepatic and renal function * Written informed consent * Target Population for the PK substudy must obtain written informed consent from subject, or from parents or legal guardians for minor subjects, according to local law and regulation * Target Population for the PK substudy subjects must have CP-CML and be taking daily dasatinib (tablets or PFOS) either as part of Cohort 1 or Cohort 3 of this protocol. Patients receiving commercial dasatinib tablets outside of this protocol may be invited to participate in this PK substudy * Target Population for the PK substudy subjects with CP-CML who are tolerating dasatinib tablet dose of at least 60 mg/m2 or dasatinib PFOS dose of at least 72 mg/m2 * Target Population for the PK substudy prior exposure to imatinib or other TKI therapy is permissible * Target Population for the PK substudy subjects must meet relevant inclusion criteria Exclusion Criteria: * Eligibility for potentially-curative therapy including hematopoietic stem-cell transplantation * Symptomatic CNS involvement (other than signs and symptoms caused by leptomeningeal disease) * Isolated extramedullary disease * Prior therapy with Dasatinib * Target Population for the PK substudy subjects participating in the PK substudy must comply with the relevant exclusion criteria * Target Population for the PK substudy subjects are not allowed to use proton pump inhibitors, H2 antagonists, CYP3A4 inhibitors and inducers when entering the PK substudy Other inclusion/exclusion criteria may apply
References
Publications (1)
- DERIVEDGore L, Kearns PR, de Martino ML, Lee, De Souza CA, Bertrand Y, Hijiya N, Stork LC, Chung NG, Cardos RC, Saikia T, Fagioli F, Seo JJ, Landman-Parker J, Lancaster D, Place AE, Rabin KR, Sacchi M, Swanink R, Zwaan CM. Dasatinib in Pediatric Patients With Chronic Myeloid Leukemia in Chronic Phase: Results From a Phase II Trial. J Clin Oncol. 2018 May 1;36(13):1330-1338. doi: 10.1200/JCO.2017.75.9597. Epub 2018 Mar 2. PMID 29498925