An Open Label, 3-arm, Randomised Phase II Study to Compare the Safety and Efficacy of Ponatinib in Combination With Either Chemotherapy or Blinatumomab With Imatinib Plus Chemotherapy as Front-line Therapy for Patients Aged 55 Years and Over With Philadelphia Chromosome Positive (Ph+ or BCR-ABL+) Acute Lymphoblastic Leukemia (ALL)
Name: Ponatinib
Name: Blinatumomab
Name: Imatinib
Description: Achievement of a molecular response in treatment arms 1 and 2 defined by a BCR-ABL1/ABL1 (B/A) transcript ratio of ≤10-4 by the time point scheduled for MRD analysis
Measure: Number of patients with a demonstrable molecular response Time: Within 5 months after start of study treatmentAllocation: Randomized
Factorial Assignment
There is one SNP
In particular, a BCR-ABL mutation known as T315I has been recognized to cause resistance to all approved 1st and 2nd generation TKI. --- T315I ---
More recently, a highly potent 3rd generation TKI called ponatinib has been developed and is the only approved TKI shown to be active against the T315I and all other resistance mutations. --- T315I ---