CompletedPhase 2ACTRN12607000609459

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


Sponsor

Australasian Leukaemia and Lymphoma Group (ALLG)

Enrollment

20 participants

Start Date

Nov 7, 2008

Study Type

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

Sex: Both males and femalesMin Age: 16 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates dasatinib plus Chemotherapy in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukaemia. It is open to aged 16 to 70. To join, participants should meet criteria including: patients aged between 16 and 70 years (inclusive). People who have exposure to any other investigational agents within 30 days of registration.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 us

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)

New Zealand

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ACTRN12607000609459