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

COMPLETEDPHASE2/PHASE3

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

NCT00264160•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (4)

Novartis Investigative Site

Haifa, Israel

Novartis Investigative Site

Jerusalem, Israel

Novartis Investigative Site

Petah Tikva, Israel

Novartis Investigative Site

Tel Litwinsky, Israel

Key Dates

Start Date

May 1, 2006

Primary Completion Date

November 1, 2008

Completion Date

August 1, 2009

Last Updated

March 6, 2017

Enrollment

ACTUAL participants

Conditions

Leukemia, Myeloid, Chronic

Interventions

AMN107

DRUG

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TERMINATEDPHASE2

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TERMINATEDPHASE1/PHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Treatment Patterns and Key Endpoints Among Patients With Chronic-Phase Chronic Myeloid Leukemia in a Community Oncology Setting

Efficacy and Safety of LBH589B in Adult Patients With Refractory Chronic Myeloid Leukemia in Accelerated or Blast Phase

Transplantation of Umbilical Cord Blood Following Chemotherapy for Blood Cancers

Safety Assessment of Two Schedules of Intravenous Infusions of SNS-595 for the Treatment of Hematologic Malignancies

High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML)

Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance