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

NCT ID: NCT00109707

Last Updated: 2021-06-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

507 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2012-09-30

Brief Summary

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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)

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Detailed Description

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Conditions

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Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia (Philadelphia Chromosome Positive) Hypereosinophilic Syndrome Systemic Mastocytosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CML-CP With Prior Imatinib Only

Imatinib-resistant / intolerant PH+ CML-CP patients

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

CML-AP With Prior Imatinib Onl

Imatinib-resistant / intolerant PH+ CML-AP patients

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

CML-CP

Imatinib-resistant / intolerant PH+ CML-CP patients

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

Interventions

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Nilotinib

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticlas

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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City of Hope National Medical Center

Duarte, California, United States

Site Status

Stanford University Medical Center

Stanford, California, United States

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University of Colorado Hospital

Aurora, Colorado, United States

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

Tampa, Florida, United States

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

Chicago, Illinois, United States

Site Status

University of Illinois at Chicago Divisionof Hematology/Oncology

Chicago, Illinois, United States

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

Beech Grove, Indiana, United States

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Ochsner Clinic Foundation

New Orleans, Louisiana, United States

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

Baltimore, Maryland, United States

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Dana Farber Cancer Institute

Boston, Massachusetts, United States

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University of Michigan Health System Clinical Trials Office

Ann Arbor, Michigan, United States

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Wayne State University

Detroit, Michigan, United States

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Mayo Clinic - Rochester

Rochester, Minnesota, United States

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Hackensack University Medical Center

Hackensack, New Jersey, United States

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Roswell Park Cancer Institute Rosewell SC

Buffalo, New York, United States

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Memorial Sloan Kettering Cancer Center

New York, New York, United States

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University of Rochester Medical Center

Rochester, New York, United States

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Duke University Medical Center

Durham, North Carolina, United States

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Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, United States

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Oregon Health Sciences University

Portland, Oregon, United States

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The Jones Clinic

Germantown, Tennessee, United States

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Vanderbilt University Medical Center, Clinical Trials Center Investigational Drug Services

Nashville, Tennessee, United States

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MD Anderson Cancer Center/University of Texas

Houston, Texas, United States

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Swedish Cancer Institute

Seattle, Washington, United States

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Novartis Investigative Site

St Leonards, New South Wales, Australia

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Adelaide, South Australia, Australia

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Prahran, Victoria, Australia

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Vienna, , Austria

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Brussels, , Belgium

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Haine-Saint-Paul, , Belgium

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Leuven, , Belgium

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Yvoir, , Belgium

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Vancouver, British Columbia, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Vejle, , Denmark

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HUS Helsinki, , Finland

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Bordeaux, , France

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Créteil, , France

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Dijon, , France

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Lille, , France

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Limoges, , France

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Lyon, , France

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Marseille, , France

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Poitiers, , France

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Rennes, , France

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Vandœuvre-lès-Nancy, , France

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Berlin, , Germany

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Düsseldorf, , Germany

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Frankfurt/M, , Germany

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Hamburg, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Mannheim, , Germany

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München, , Germany

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Pokfulam, Hong Kong, Hong Kong

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Bergamo, BG, Italy

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Bologna, BO, Italy

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Genova, GE, Italy

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Monza, MB, Italy

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Milan, MI, Italy

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Pescara, PE, Italy

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Pavia, PV, Italy

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Reggio Calabria, RC, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Roma, RM, Italy

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Orbassano, TO, Italy

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Napoli, , Italy

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Amsterdam, , Netherlands

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Rotterdam, , Netherlands

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Grafton, Auckland, New Zealand

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Oslo, , Norway

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Katowice, , Poland

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Lodz, , Poland

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Warsaw, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Singapore, , Singapore

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Hwasun-gun, Jeollanam-do, South Korea

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Seoul, Korea, South Korea

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Seoul, Korea, South Korea

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Taegu, , South Korea

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Barcelona, Catalonia, Spain

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L'Hospitalet de Llobregat, Catalonia, Spain

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Gothenburg, , Sweden

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Linköping, , Sweden

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Lund, , Sweden

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Uppsala, , Sweden

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Basel, , Switzerland

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Geneva, , Switzerland

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Niaosong Township, Taiwan, Taiwan

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Birmingham, , United Kingdom

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Cambridge, , United Kingdom

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Glasgow - Scotland, , United Kingdom

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Leeds, , United Kingdom

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Liverpool, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Countries

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United States Australia Austria Belgium Canada Denmark Finland France Germany Hong Kong Italy Netherlands New Zealand Norway Poland Singapore South Korea Spain Sweden Switzerland Taiwan United Kingdom

References

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Hochhaus A, Baccarani M, Giles FJ, le Coutre PD, Muller MC, Reiter A, Santanastasio H, Leung M, Novick S, Kantarjian HM. Nilotinib in patients with systemic mastocytosis: analysis of the phase 2, open-label, single-arm nilotinib registration study. J Cancer Res Clin Oncol. 2015 Nov;141(11):2047-60. doi: 10.1007/s00432-015-1988-0. Epub 2015 May 23.

Reference Type DERIVED
PMID: 26002753 (View on PubMed)

Hochhaus A, le Coutre PD, Kantarjian HM, Baccarani M, Erben P, Reiter A, McCulloch T, Fan X, Novick S, Giles FJ. Effect of the tyrosine kinase inhibitor nilotinib in patients with hypereosinophilic syndrome/chronic eosinophilic leukemia: analysis of the phase 2, open-label, single-arm A2101 study. J Cancer Res Clin Oncol. 2013 Dec;139(12):1985-93. doi: 10.1007/s00432-013-1529-7. Epub 2013 Sep 22.

Reference Type DERIVED
PMID: 24057647 (View on PubMed)

Stein AM, Martinelli G, Hughes TP, Muller MC, Beppu L, Gottardi E, Branford S, Soverini S, Woodman RC, Hochhaus A, Kim DW, Saglio G, Radich JP. Rapid initial decline in BCR-ABL1 is associated with superior responses to second-line nilotinib in patients with chronic-phase chronic myeloid leukemia. BMC Cancer. 2013 Apr 2;13:173. doi: 10.1186/1471-2407-13-173.

Reference Type DERIVED
PMID: 23547655 (View on PubMed)

Kantarjian HM, Giles FJ, Bhalla KN, Pinilla-Ibarz J, Larson RA, Gattermann N, Ottmann OG, Hochhaus A, Radich JP, Saglio G, Hughes TP, Martinelli G, Kim DW, Shou Y, Gallagher NJ, Blakesley R, Baccarani M, Cortes J, le Coutre PD. Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results. Blood. 2011 Jan 27;117(4):1141-5. doi: 10.1182/blood-2010-03-277152. Epub 2010 Nov 22.

Reference Type DERIVED
PMID: 21098399 (View on PubMed)

Kantarjian HM, Giles F, Gattermann N, Bhalla K, Alimena G, Palandri F, Ossenkoppele GJ, Nicolini FE, O'Brien SG, Litzow M, Bhatia R, Cervantes F, Haque A, Shou Y, Resta DJ, Weitzman A, Hochhaus A, le Coutre P. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood. 2007 Nov 15;110(10):3540-6. doi: 10.1182/blood-2007-03-080689. Epub 2007 Aug 22.

Reference Type DERIVED
PMID: 17715389 (View on PubMed)

Kantarjian H, Giles F, Wunderle L, Bhalla K, O'Brien S, Wassmann B, Tanaka C, Manley P, Rae P, Mietlowski W, Bochinski K, Hochhaus A, Griffin JD, Hoelzer D, Albitar M, Dugan M, Cortes J, Alland L, Ottmann OG. Nilotinib in imatinib-resistant CML and Philadelphia chromosome-positive ALL. N Engl J Med. 2006 Jun 15;354(24):2542-51. doi: 10.1056/NEJMoa055104.

Reference Type DERIVED
PMID: 16775235 (View on PubMed)

Related Links

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https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=9963

Results for CAMN107A2101 on the Novartis Clinical Trials Website

Other Identifiers

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CAMN107A2101

Identifier Type: -

Identifier Source: org_study_id

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