Conditions: Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive) Hypereosinophilic Syndrome Systemic Mastocytosis
Keywords: CML in blast crisis CML in chronic phase CML in accelerated phase Gleevec resistance Gleevec intolerant Gleevec and CML imatinib resistance imatinib intolerant Hypereosinophilic Syndrome Systemic Mastocytosis Chronic eosinophilic syndrome Philadelphia chromosome positive acute lymphoblastic leukemia HES CEL CML SM Ph+ ALL refractory to standard therapy Ph+ALL relapsed AMN107A
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 507
Healthy volunteers: no

Brief 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)

Detailed description:

Arms:
arm 1: Imatinib-resistant / intolerant PH+ CML-CP patients arm 2: Imatinib-resistant / intolerant PH+ CML-AP patients arm 3: Imatinib-resistant / intolerant PH+ CML-CP patients

Interventions: intervention 1: Nilotinib
Intervention descriptions: intervention 1: None

Protocol document: