Leukemia Clinical Trial
Official title:
A Phase II Study of the Combination of Ponatinib With Mini-hyper CVD Chemotherapy and Venetoclax in Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia
The addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia
OBJECTIVES The addition of ponatinib to mini-hyper-CVD chemotherapy and venetoclax will improve the complete remission rate in patients with relapsed or refractory T-cell acute lymphoblastic leukemia. Primary Objective: To assess complete remission (CR) / CR with incomplete count recovery (CRi) rate with the combination of Ponatinib and mini-hyper-CVD chemotherapy and venetoclax. Secondary Objectives: To assess the safety of the regimen To assess rate of measurable residual disease (MRD) negative remission To assess duration of response (DOR), progression-free survival (PFS) and overall survival (OS) Exploratory Objectives: To assess the level of phospho-LCK in pretreatment samples and correlation with the To assess expression of BCL-2 family proteins ;
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