At a glance
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A Phase I, Multicenter, Open-label Study of Oral ABL001 in Patients With Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL)
In Brief
A Phase 1 clinical trial evaluating Asciminib (ABL001), Nilotinib, and 2 other interventions for Chronic Myelogenous Leukemia and Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia. Completed, enrolled 326 participants across 18 sites in 10 countries.
Detailed Summary
The design of a phase I, open label, dose finding study was chosen in order to establish a safe and tolerated dose of single agent ABL001 in Chronic myeloid leukemia (CML) and Philadelphia chromosome positive Acute lymphoblastic leukemia (Ph+ ALL) patients who are relapsed or refractory to or are intolerant of Tyrosine kinase inhibitors (TKIs), and of ABL001+Nilotinib, ABL001+Imatinib and ABL001+Dasatinib in Ph positive CML patients who are relapsed or refractory to TKIs.
Study Details
Timeline
Interventions
Asciminib was be administered orally in a dose escalation schedule.
Asciminib and Nilotinib was administered orally in CML patients
Asciminib and imatinib was administered orally in CML patients
Asciminib and dasatinib was administered orally in CML patients