ACTRN12607000609459
Completed
Phase 2
A Phase II Study of Dasatinib Combined with Induction Chemotherapy in Previously Untreated de novo Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia to Assess Safety and Tolerability
Australasian Leukaemia and Lymphoma Group (ALLG)0 sites20 target enrollmentNovember 28, 2007
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Australasian Leukaemia and Lymphoma Group (ALLG)
- Enrollment
- 20
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Patients aged between 16 and 70 years (inclusive)
- •2\.Patients with a confirmed diagnosis of Ph\+ ALL
- •3\.Female patients of childbearing potential must have a negative pregnancy test, conducted within 7 days prior to registration.
- •4\.Patient has given written informed consent.
- •5\.Previously untreated with antineoplastic therapy for Ph\+ A
Exclusion Criteria
- •1\.Exposure to any other investigational agents within 30 days of registration.
- •2\.Known sensitivity to dasatinib
- •3\.Eastern Cooperative Oncology Group (ECOG) performance status score \> 2
- •4\.Left ventricular ejection fraction \< 50%
- •5\.Creatinine \>/\= 1\.5 x the upper limit of normal (ULN)
- •6\.Serum bilirubin \>/\= 2 x ULN
- •7\.AST or ALT \> 2\.5 x ULN
- •8\.Known HIV or hepatitis B seropositivity
- •9\.Pregnancy or breastfeeding
- •10\. Prior diagnosis or evidence of chronic myeloid leukaemia (CML)
Outcomes
Primary Outcomes
Not specified
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