Efficacy and Safety of Oral AMN107 in Adults With Chronic Myelogenous Leukemia Resistant and/or Intolerant to Imatinib Mesylate Therapy

Novartis Pharmaceuticals36 enrolled

Overview

This open-label, multicenter trial will evaluate the efficacy and safety of treatment with AMN107 in chronic myelogenous leukemia (CML) patients that are resistant and/or intolerant to imatinib mesylate therapy.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Leukemia, Myeloid, Chronic

Interventions

AMN107DRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Imatinib - resistant or - intolerant Philadelphia chromosome-positive CML in blast crisis, accelerated or chronic phase * Males or females ≥ 18 years of age Exclusion Criteria: * Impaired cardiac function * Acute or chronic liver or renal disease * Use of therapeutic coumadin * Central nervous system (CNS) infiltration Additional protocol-defined inclusion/exclusion criteria may apply.

Locations (4)

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Jerusalem, Israel

Novartis Investigative Site

Petah Tikva, Israel

Novartis Investigative Site

Tel Litwinsky, Israel

Outcomes

Primary Outcomes

Cytogenetic response within 12 months

Time frame: Every 6 months for 12 months

Secondary Outcomes

To determine the rate of hematologic response at 12 months

Time frame: Every Visit for 12 months

To determine the rate of molecular response at 12 months

Time frame: Every 3 months for 12 months

To evaluate the time to cytogenetic and molecular response

Time frame: At 12 months

Data from ClinicalTrials.gov

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