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

Completed · Phase 1/Phase 2

Conditions studied: Chronic Myelogenous Leukemia, Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive), Hypereosinophilic Syndrome, Systemic Mastocytosis

In brief

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)

Key facts

Study ID

NCT00109707

Run by

Novartis Pharmaceuticals

People needed

507

Starts

2005-04-01

Expected to finish

2012-09-01

Last updated by the study team

2021-06-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Main inclusion criteria include:
• 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

You may not qualify if…

• 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
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• 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
• University of Michigan Health System Clinical Trials Office — Ann Arbor, Michigan, United States
• Wayne State University — Detroit, Michigan, United States
• Mayo Clinic - Rochester — Rochester, Minnesota, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Roswell Park Cancer Institute Rosewell SC — Buffalo, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States
• Oregon Health Sciences University — Portland, Oregon, United States
• The Jones Clinic — Germantown, Tennessee, United States
• Vanderbilt University Medical Center, Clinical Trials Center Investigational Drug Services — Nashville, Tennessee, United States
• MD Anderson Cancer Center/University of Texas — Houston, Texas, United States
• Swedish Cancer Institute — Seattle, Washington, United States
• Novartis Investigative Site — St Leonards, New South Wales, Australia
• City of Hope National Medical Center — Duarte, California, United States

Full record on ClinicalTrials.gov

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