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A Phase I Study of Oral Asciminib (ABL001) in Patients With CML or Ph+ ALL
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.
Details
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | PHASE1 |
| Status | COMPLETED |
| Enrolment | 326 |
| Start date | Thu Apr 24 2014 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Tue Mar 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Chronic Myelogenous Leukemia
- Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia
Interventions
- Asciminib (ABL001)
- Nilotinib
- Imatinib
- Dasatinib
Countries
France, Italy, Japan, Netherlands, Germany, South Korea, Australia, Singapore, United States, Spain