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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00264160

Enrollment

Registered

2005-12-12

Start date

2006-05-31

Completion date

2009-08-31

Last updated

2017-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Myeloid, Chronic

Keywords

AMN107, CML, Bcr Abl, cytogenetic response, Chronic Myelogenous Leukemia (CML), imatinib mesylate

Brief summary

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.

Interventions

DRUGAMN107

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
Cytogenetic response within 12 months	Every 6 months for 12 months

Secondary

Measure	Time frame
To determine the rate of hematologic response at 12 months	Every Visit for 12 months
To determine the rate of molecular response at 12 months	Every 3 months for 12 months
To evaluate the time to cytogenetic and molecular response	At 12 months

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026