CA180226: PII childhood leukaemia dasatinib study (version 1 9/Jul/08)
Research type
Research Study
Full title
A Phase II Study of Dasatinib Therapy in Children and Adolescents with Ph+ Leukaemia with Resistance or Intolerance to Imatinib (version 1 9/Jul/08)
IRAS ID
13368
Contact name
Pamela Kearns
Sponsor organisation
Bristol Myers Squibb International Corporation
Eudract number
2008-002260-33
ISRCTN Number
N/A
Clinicaltrials.gov Identifier
Research summary
Leukaemia is a disease of the blood and is the most common childhood cancer. There are different types of leukaemia depending on how quickly it develops and the type of white blood cells affected. This study looks at specific types of childhood leukaemia where an abnormal chromosome called the Philadelphia chromosome is present. There have been major advances in the treatment of childhood leukaemia over the last 2 decades, but there??s still a need to improve treatments, particularly for those patients who don??t respond or relapse on current therapies. Targeted tyrosine kinase inhibitors, like dasatinib, that target the Philadelphia chromosome are being studied to determine if they may improve response rates. Dasatinib is currently approved for treatment of certain adult leukaemias. This Phase II study aims to find out if dasatinib can improve the treatment outcomes of certain types of childhood leukaemias: Chronic Myeloid Leukaemia (CML) and Acute Lymphoblastic Leukaemia (ALL) in different stages. Approximately 109 patients in total will be treated, all patients with the same type of leukaemia will receive the same dose of drug. Patients will receive dasatinib orally once daily. One dose escalation will be allowed for patients who are tolerating treatment but do not achieve an acceptable response. During the study patients who consent will undergo: physical examinations, blood tests, a chest x-ray, an ECG, an Echocardiogram, Bone Marrow Aspirates and in some cases a lumbar puncture. Patients will be continually monitored and their treatment stopped if they do not respond or are unable to tolerate any side effects. Patients will be followed for up to 5 years to see how they are doing after treatment. This study is funded by Bristol Myers Squibb and is being carried out approximately 80 centres worldwide. There are 3 UK centres and the study commenced in November 2009.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
09/H0405/51
Date of REC Opinion
12 Nov 2009
REC opinion
Further Information Favourable Opinion