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
Leukemia
About this trial
This is an interventional treatment trial for Leukemia focused on measuring Leukemia, Pediatric
Eligibility Criteria
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
Sites / Locations
- Local Institution
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- Phoenix Children'S Hospital
- Jonathan Jaques Children'S Cancer Center
- Jonathan Jaques Children'S Cancer Center
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- Children'S Hospital Of Orange County
- Local Institution - 0024
- Children'S Hospital
- Local Institution - 0004
- Children's Healthcare of Atlanta - Egleston Hospital
- Children's Healthcare Of Atlanta - Egleston
- Children's Hospital of Chicago
- Local Institution - 0072
- Local Institution
- Dana Faber Cancer Institute
- Dana Farber Cancer Institute.
- Local Institution - 0040
- Stephen D. Hassenfeld Children'S Center
- Local Institution - 0061
- Memorial Sloan Kettering Cancer Center
- Memorial Sloan Kettering Nassau
- Oregon Health & Sci Univ
- Local Institution - 0002
- Oregon Health & Sci Univ
- Children'S Hospital Of Philadelphia
- Local Institution - 0014
- Children'S Hospital Of Pittsburgh
- Local Institution - 0003
- Local Institution - 0035
- MD Anderson Cancer Center
- Local Institution - 0048
- Texas Children'S Cancer Center
- Local Institution - 0028
- Seattle Children'S
- Local Institution - 0043
- Local Institution
- Hospital Nacional Profesor Alejandro Posadas
- Local Institution - 0049
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- Alberta Children'S Hospital
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- Stollery Children'S Hospital
- Bc Children'S Hospital
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- Iwk Health Centre
- Local Institution - 073
- Children'S Hospital Of Eastern Ontario
- Local Institution - 086
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- The Hospital For Sick Children
- Chu Ste-Justine
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- Hospital Civil De Guadalajara - Nuevo Dr. Juan I. Menchaca
- Local Institution - 0054
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- Local Institution
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- Local Institution
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Cohort 1: Imatinib-resistant/intolerant CP-CML
Cohort 2: Ph+ALL or AP- or BP-CML
Cohort 3: Newly diagnosed, treatment naïve CP-CML
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 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 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