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A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies

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.

NCT00109707•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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)

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients with CML in blast crisis, CML in accelerated phase defined as never in blast crisis phase, or CML in chronic phase defined as never been in blast crisis phase or accelerated phase who have: \*developed progressive disease during therapy with at least 600 mg of imatinib per day, -OR- \*patients with CML on imatinib therapy, at any dose, developing progressive disease and the presence of a genetic mutation likely to result in imatinib resistance -OR- \*have developed an intolerance to imatinib
•Relapsed or refractory Ph+ ALL
•Hypereosinophilic syndrome/chronic eosinophilic leukemia.
•Systemic mastocytosis who have a clinical indication for treatment.
•Prior imatinib therapy for patients with Ph+ ALL, HES/CEL and SM is permitted but is not required
•CML patients who have been treated with an investigational tyrosine kinase inhibitor who otherwise meet the definition of imatinib-resistance or intolerance are eligible
•Written informed consent prior to any study procedures being performed

Exclusion Criteria

•Impaired cardiac function
•Patients with severe/chronic or uncontrolled medical conditions (including but not limited to diabetes, infections, GI impairment, CNS infiltration, liver and kidney disease)
•Prior and concomitant use of certain medications (including but not limited to warfarin, chemotherapy, hematopoietic colony-stimulating growth factors, medications that can affect electrocardiogram test results, other investigational drugs )
•Women who are pregnant or breastfeeding
•Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention.
•Patients unwilling to comply with the protocol.
•Known diagnosis of human immunodeficiency virus (HIV) infection

Locations (101)

City of Hope National Medical Center

Duarte, California, United States

Stanford University Medical Center

Stanford, California, United States

University of Colorado Hospital

Aurora, Colorado, United States

H. Lee Moffitt Cancer Center & Research Institute Dept.of H. Lee Moffitt

Tampa, Florida, United States

University of Chicago Medical Center Dept. of U. of Chicago Hosp(3)

Chicago, Illinois, United States

University of Illinois at Chicago Divisionof Hematology/Oncology

Chicago, Illinois, United States

Indiana Blood and Marrow Institute Dept of Indiana Blood&Mar (2)

Beech Grove, Indiana, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Sidney Kimmel Comprehensive Cancer Center/Johns Hopkins Med. Div.of Hematologic Malignancie

Baltimore, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Key Dates

Start Date

April 1, 2005

Primary Completion Date

September 1, 2012

Completion Date

September 1, 2012

Last Updated

June 29, 2021

Enrollment

507

ACTUAL participants

Conditions

Chronic Myelogenous LeukemiaAcute Lymphoblastic Leukemia (Philadelphia Chromosome Positive)Hypereosinophilic SyndromeSystemic Mastocytosis

Interventions

Nilotinib

DRUG

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

NCT06859424

AML (Acute Myelogenous Leukemia)Acute Lymphoid Leukemia (ALL)+9 more

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RECRUITING

Natural History of Hypereosinophilia and Hypereosinophilic Syndromes

NCT04018118

EosinophiliaHypereosinophilic Syndrome

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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: June 29, 2021Data 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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A Study of Oral AMN107 in Adults With Chronic Myelogenous Leukemia (CML) or Other Hematologic Malignancies

Inclusion Criteria

Exclusion Criteria

A Platform Protocol to Investigate Post-Transplant Cyclophosphamide-Based Graft-Versus-Host Disease Prophylaxis in Patients With Hematologic Malignancies Undergoing Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation

Natural History of Hypereosinophilia and Hypereosinophilic Syndromes

Ruxolitinib in Treating Patients With Hypereosinophilic Syndrome or Primary Eosinophilic Disorders

Chart Review Study of Chronic Myelogenous Leukemia (CML) Patients Treated With Imatinib Outside of a Clinical Trial

Myeloablative Allo HSCT With Related or Unrelated Donor for Heme Disorders

MCW Alpha/Beta T-Cell and B-Cell Depletion With Targeted ATG Dosing