Nilotinib vs Imatinib in Adult Patients With Philadelphia (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (ENEST)

November 4, 2011 updated by: Novartis Pharmaceuticals

A Phase III Randomized, Open- Label Multi-center Study of Nilotinib Versus Imatinib in Adult Patients With Ph+ Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) Who Have a Suboptimal Cytogenetic Response (CyR) on Imatinib

In this study, the efficacy and safety of nilotinib 400 mg twice daily, will be compared with imatinib 400 mg twice daily in patients with a suboptimal response to imatinib for their Philadelphia chromosome-positive (Ph+) Chronic Myelogenous Leukemia in the chronic phase (CML-CP).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This trial was to evaluate the CCyR rate at 12 months of nilotinib therapy when compared to imatinib treatment in patients with suboptimal response to imatinib. The patients were stratified by prior duration of initial imatinib treatment, and were randomized to receive either 400 mg/twice daily of continuous nilotinib or imatinib treatment. The first stratum patients were treated with imatinib = 6 to < 12 months and having at least a minimal cytogenetic, but no partial cytogenetic response; and the second stratum patients were treated with imatinib = 12 months to < 18 months and having partial cytogenetic response (PCyR), but no CCyR.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Darlinghurst, Australia
        • Novartis Investigative Site
      • Herston, Australia
        • Novartis Investigative Site
      • Liverpool, Australia
        • Novartis Investigative Site
      • Perth, Australia
        • Novartis Investigative Site
      • Prahran, Australia
        • Novartis Investigative Site
      • South Brisbane, Australia
        • Novartis Investigative Site
      • St. Leonards, Australia
        • Novartis Investigative Site
  • Belgium
      • Brugge, Belgium
        • Novartis Investigative Site
      • Gent, Belgium
        • Novartis Investigative Site
      • Leuven, Belgium
        • Novartis Investigative Site
  • Brazil
      • Mannheim, Brazil
        • Novartis Investigative Site
      • Porto Alegre, Brazil
        • Novartis Investigative Site
      • Sao Paulo, Brazil
        • Novartis Investigative Site
  • Czech Republic
      • Olomouc, Czech Republic
        • Novartis Investigative Site
      • Praha, Czech Republic
        • Novartis Investigative Site
  • Germany
      • Berlin, Germany
        • Novartis Investigative Site
      • Duesseldorf, Germany
        • Novartis Investigative Site
      • Eisensach, Germany
        • Novartis Investigative Site
      • Firenze, Germany
        • Novartis Investigative Site
      • Griefswald, Germany
        • Novartis Investigative Site
      • Hamburg, Germany
        • Novartis Investigative Site
      • Jena, Germany
        • Novartis Investigative Site
      • Kiel, Germany
        • Novartis Investigative Site
      • Leipzeg, Germany
        • Novartis Investigative Site
      • Postsdam, Germany
        • Novartis Investigative Site
      • Rostock, Germany
        • Novartis Investigative Site
      • Stuttgart, Germany
        • Novartis Investigative Site
      • Weiden, Germany
        • Novartis Investigative Site
  • Italy
      • Bologna, Italy
        • Novartis Investigative Site
      • Milano, Italy
        • Novartis Investigative Site
      • Napoli, Italy
        • Novartis Investigative Site
      • Orbassano, Italy
        • Novartis Investigative Site
      • Reggio Calabra, Italy
        • Novartis Investigative Site
      • Roma, Italy
        • Novartis Investigative Site
  • Japan
      • Nagoya, Japan
        • Novartis Investigative Site
      • Oaska, Japan
        • Novartis Investigative Site
      • Tokyo, Japan
        • Novartis Investigative Site
  • Korea, Republic of
      • Hwasun-Gun, Korea, Republic of
        • Novartis Investigative Site
      • Seoul, Korea, Republic of
        • Novartis Investigative Site
  • Spain
      • Barcelona, Spain
        • Novartis Investigative Site
      • Madrid, Spain
        • Novartis Investigative Site
      • Salamanca, Spain
        • Novartis Investigative Site
      • Santiago de Compostela, Spain
        • Novartis Investigative Site
      • Valencia, Spain
        • Novartis Investigative Site
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85701
        • Arizona Cancer Center
    • California
      • Anaheim, California, United States, 92801
        • Southern California Permanente Medical Group
      • Baldwin Park, California, United States, 91706
        • Southern California Permanente Medical Group
      • Fontana, California, United States, 92334
        • Southern California Permanente Medical Group
      • Hayward, California, United States, 94540
        • Kaiser Permanente Medical Group/Hayward Medical Center
      • Los Angeles, California, United States, 90001
        • Southern California Permanente Medical Group
      • Oakland, California, United States, 94601
        • Kaiser Permanente Medical Group/Oakland Medical Center
      • Panorama City, California, United States, 91402
        • Southern California Permanente Medical Group
      • Riverside, California, United States, 92501
        • Southern California Permanente Medical Group
      • S. San Francisco, California, United States, 94101
        • Kaiser Permanente Medical Group/South San Francisco Medical Center
      • Sacramento, California, United States, 94203
        • Kaiser Permanente Medical Group/Sacramento Medical Center
      • San Diego, California, United States, 92101
        • Southern California Permanente Medical Group
      • San Francisco, California, United States, 94101
        • Kaiser Permanente Medical Group
      • San Jose, California, United States, 95101
        • Kaiser Permanente Medical Group
      • Santa Clara, California, United States, 95050
        • Kaiser Permanente Medical Group/Santa Clara Medical Office
      • Vallejo, California, United States, 94589
        • Kaiser Permanente Medical Group/Vallejo Medical Center
      • Walnut Creek, California, United States, 94595
        • Kaiser Permanente Medical Group/Walnut Creek Medical Center
      • Woodland Hills, California, United States, 91364
        • Southen California Permanente Medical Group
    • Colorado
      • Denver, Colorado, United States, 80201
        • Rocky Mountain Cancer Center
    • Illinois
      • Chicago, Illinois, United States, 60601
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 60601
        • The University of Chicago Medical Center
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Indiana Blood and Marrow Transplantation
    • Iowa
      • Iowa City, Iowa, United States, 52240
        • Holden Cancer Center
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Johns Hopkins Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48103
        • University of Michigan
      • Grand Rapids, Michigan, United States, 49501
        • Hematology Centers of Western Michigan
    • Nebraska
      • Omaha, Nebraska, United States, 68101
        • Methodist Cancer Center
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • The Cancer Center at Hackensack University Medical Center
    • North Carolina
      • Durham, North Carolina, United States, 27701
        • Duke University Hospital
      • Winston-Salem, North Carolina, United States, 27101
        • Wake Forest University Health Sciences
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences University
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
        • St. Luke's Hospital and Health Network
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Jones Cancer Center
      • Nashville, Tennessee, United States, 37201
        • Vanderbilt University
    • Texas
      • Houston, Texas, United States, 77001
        • University of Texas/MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Swedish Cancer Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

Diagnosis of Philadelphia chromosome positive chronic myelogenous leukemia in the chronic phase.

Patients with suboptimal cytogenetic response to a dose of 400 mg imatinib (first line therapy) defined as:

  • 6 to < 12 months of treatment and -have 36 - 95% Ph+ metaphases, or
  • 12 to <18 months of treatment and have 1 - 35% Ph+ metaphases (Standard cytogenetics, no FISH [fluorescence in situ hybridization] analysis was allowed).

Exclusion criteria:

  • Patient who have received more than 18 months of imatinib therapy
  • Patients who have achieved partial or complete cytogenetic response and lost that response prior to entering the study.
  • Prior treatment with greater than 400 mg/day imatinib.
  • Uncontrolled or significant cardiovascular disease.
  • Severe or uncontrolled medical conditions (i.e. uncontrolled diabetes, active or uncontrolled infection).
  • Use of therapeutic coumarin derivatives (i.e., warfarin, acenocoumarol, phenprocoumon)
  • Currently taking certain medications that could affect the rhythm of your heart.

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nilotinib (AMN107)
Drug: Nilotinib (AMN107)
Administered orally as a single agent on a continuous daily schedule of 400 mg bid (2 x 200 mg twice daily) without food. Once cycle comprised of 28 days.
Active Comparator: Imatinib
Drug: Imatinib
Administered orally as a single agent on a continuous daily schedule given 400 mg bid (twice daily) with food. One cycle comprised of 28 days.
Other Names:
  • Glivec®
  • STI571
  • Gleevec®
  • imatinib mesylate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib
Time Frame: 12 months
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Durable Complete Cytogenetic Response Rate
Time Frame: 24 months
Due to early termination of the trial, the number of patients was too small and imbalanced and therefore analysis was not performed.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

October 1, 2008

Study Completion (Actual)

October 1, 2008

Study Registration Dates

First Submitted

August 17, 2007

First Submitted That Met QC Criteria

August 20, 2007

First Posted (Estimate)

August 21, 2007

Study Record Updates

Last Update Posted (Estimate)

November 6, 2011

Last Update Submitted That Met QC Criteria

November 4, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAMN107A2302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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