At a glance
ClinicalIndex Comparison Record- ✓CML in chronic, accelerated, or blast crisis phase with imatinib resistance (progressive disease on ≥600 mg/day or presence of resistance-conferring mutation) OR imatinib intolerance
- ✓Relapsed or refractory Ph+ ALL
- ✓Hypereosinophilic syndrome/chronic eosinophilic leukemia
- ✓Systemic mastocytosis with clinical indication for treatment
- ✕Impaired cardiac function
- ✕Severe/chronic or uncontrolled medical conditions (diabetes, infections, GI impairment, CNS infiltration, liver and kidney disease)
- ✕Prior or concomitant warfarin, chemotherapy, hematopoietic colony-stimulating growth factors, or other investigational drugs
- ✕Pregnancy or breastfeeding
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase IA/II Multicenter, Dose-escalation Study of Oral AMN107 on a Continuous Daily Dosing Schedule in Adult Patients With Imatinib-resistant/Intolerant CML in Chronic or Accelerated Phase or Blast Crisis, Relapsed/Refractory Ph+ ALL, and Other Hematologic Malignancies.
In Brief
A Phase 2 clinical trial evaluating Nilotinib for Chronic Myelogenous Leukemia and 3 related conditions. Completed, enrolled 507 participants across 101 sites in 22 countries.
Detailed Summary
The purpose of this trial is to assess the efficacy, safety, tolerability, biologic activity, and pharmacokinetics of AMN107 in six groups of patients with one of the following conditions: Relapsed/refractory Ph+ Acute lymphoblastic leukemia (ALL) (arm 1) Group A - Imatinib failure only (arms 2, 3 and 4) * imatinib-resistant or intolerant CML - Chronic Phase (CP) * imatinib-resistant or intolerant CML - Accelerated Phase (AP) * imatinib-resistant or intolerant CML - Blast Crisis (BC) Group B - Imatinib and other TKI failure (arms 2, 3 and 4) * imatinib-resistant or intolerant CML - Chronic Phase (CP) * imatinib-resistant or intolerant CML - Accelerated Phase (AP) * imatinib-resistant or intolerant CML - Blast Crisis (BC) Hypereosinophilic syndrome/chronic eosinophilic leukemia (HES/CEL) (arm 5) Systemic mastocytosis (Sm) (arm 6)