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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 6, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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