The primary objective of the trial is to estimate the activity of BMS-354825 (Dasatinib) in de novo adult Ph+ ALL patients in terms of hematological complete remission (HCR) rate.
This open label phase II study of Dasatinib will enroll adult de novo Ph+ ALL patients. A minimum of 48 cases will be required to complete the study. Accrual is expected to be completed in 18 months. The study will be considered completed for patients in HCR after completion of a total of 12 weeks of treatment. After completion patients will go off study and will be treated according to the best treatment option for Ph+ ALL patients in 1st HCR. The enrollment in the post-remissional phase of the current GIMEMA LAL protocol will be suggested.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Rate of Hematological Complete Remission (HCR) Obtained During the BMS Induction Treatment Within Day +85 From the Start of BMS (i.e., Whenever Achieved From the Start of the Experimental Drug).
Time frame: End of the study, up to day 85
The Incidence of Grade >2 CTC-NCI Side Effects and Toxicities;
Time frame: End of study
The Best Cytogenetic Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;
Time frame: End of study
the Best Molecular Response Obtained During BMS Treatment Within Day +85, Whenever Achieved From the Start of the Experimental Drug;
Time frame: End of study
DFS, Defined as the Time Interval Between the Evaluation of HCR and Hematological Relapse of the Disease or Death in First HCR;
Time frame: End of study
the Cumulative Incidence of Relapse;
Time frame: End of study
OS, Defined as the Time Interval Between Inclusion and Death for Any Cause.
Time frame: End of study
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Bari, Bari, Italy
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Catanzaro, Catanzaro, Italy
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
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...and 26 more locations