Dasatinib plus Chemotherapy in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia
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)
20 participants
Nov 7, 2008
Interventional
Conditions
Summary
This is a study of the drug Dasatinib combined with chemotherapy for treating people with acute lymphoblastic leukaemia (cancer of bone marrow and white blood cells) who also have the Philadelphia Chromosome. Who is it for? You can join this study if you: - are aged 16–70 years - have the Philadelphia Chromosome - have acute lymphoblastic leukaemia which has not yet been treated. Trial details: All participants will receive Dasatinib tablets for 7 days prior to chemotherapy. Dasatinib will then be given at 50mg twice daily in combination with intensive chemotherapy using oral and intravenous drugs. Each course of Dasatinib plus chemotherapy lasts 14 days and a maximum of 8 courses will be given. Dasatinib is used to reduce the risk of relapse by killing cells with mutations that might otherwise be resistant to the more commonly used drug in this situation, called imatinib. The trial aims to assess the effectiveness, safety and tolerability of Dasatinib plus chemotherapy.
Eligibility
Inclusion Criteria5
- Patients aged between 16 and 70 years (inclusive)
- Patients with a confirmed diagnosis of Ph+ ALL
- Female patients of childbearing potential must have a negative pregnancy test, conducted within 7 days prior to registration.
- Patient has given written informed consent.
- Previously untreated with antineoplastic therapy for Ph+ ALL
Exclusion Criteria10
- Exposure to any other investigational agents within 30 days of registration.
- Known sensitivity to dasatinib
- Eastern Cooperative Oncology Group (ECOG) performance status score > 2
- Left ventricular ejection fraction < 50%
- Creatinine >/= 1.5 x the upper limit of normal (ULN)
- Serum bilirubin >/= 2 x ULN
- AST or ALT > 2.5 x ULN
- Known HIV or hepatitis B seropositivity
- Pregnancy or breastfeeding
- Prior diagnosis or evidence of chronic myeloid leukaemia (CML)
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Interventions
Patients will receive a 7 day ‘pre-phase’ of dasatinib (70mg tablets, twice daily) prior to chemotherapy. Dasatinib will then be given at 50mg twice daily in combination with intensive chemotherapy using oral and intravenous drugs. Intensive chemotherapy consists of alternating courses of hyper-CVAD (cyclophosphamide, vincristine, Adriamycicn, and dexamethasone) with methotrexate plus cytarabine. Each course of dasatinib plus chemotherapy lasts 14 days and a maximum of 8 courses will be given.
Locations(1)
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ACTRN12607000609459