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

NCT ID: NCT00519090

Last Updated: 2011-11-07

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2008-10-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Myelogenous Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nilotinib (AMN107)

Group Type EXPERIMENTAL

Nilotinib (AMN107)

Intervention Type DRUG

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.

Imatinib

Group Type ACTIVE_COMPARATOR

Imatinib

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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STI571 imatinib mesylate Glivec® Gleevec®

Eligibility Criteria

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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.
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 Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Southern California Permanente Medical Group

Anaheim, California, United States

Site Status

Southern California Permanente Medical Group

Baldwin Park, California, United States

Site Status

Southern California Permanente Medical Group

Fontana, California, United States

Site Status

Kaiser Permanente Medical Group/Hayward Medical Center

Hayward, California, United States

Site Status

Southern California Permanente Medical Group

Los Angeles, California, United States

Site Status

Kaiser Permanente Medical Group/Oakland Medical Center

Oakland, California, United States

Site Status

Southern California Permanente Medical Group

Panorama City, California, United States

Site Status

Southern California Permanente Medical Group

Riverside, California, United States

Site Status

Kaiser Permanente Medical Group/Sacramento Medical Center

Sacramento, California, United States

Site Status

Southern California Permanente Medical Group

San Diego, California, United States

Site Status

Kaiser Permanente Medical Group

San Francisco, California, United States

Site Status

Kaiser Permanente Medical Group

San Jose, California, United States

Site Status

Kaiser Permanente Medical Group/Santa Clara Medical Office

Santa Clara, California, United States

Site Status

Kaiser Permanente Medical Group/South San Francisco Medical Center

South San Francisco, California, United States

Site Status

Kaiser Permanente Medical Group/Vallejo Medical Center

Vallejo, California, United States

Site Status

Kaiser Permanente Medical Group/Walnut Creek Medical Center

Walnut Creek, California, United States

Site Status

Southen California Permanente Medical Group

Woodland Hills, California, United States

Site Status

Rocky Mountain Cancer Center

Denver, Colorado, United States

Site Status

Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

The University of Chicago Medical Center

Chicago, Illinois, United States

Site Status

Indiana Blood and Marrow Transplantation

Beech Grove, Indiana, United States

Site Status

Holden Cancer Center

Iowa City, Iowa, United States

Site Status

Johns Hopkins Hospital

Baltimore, Maryland, United States

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Hematology Centers of Western Michigan

Grand Rapids, Michigan, United States

Site Status

Methodist Cancer Center

Omaha, Nebraska, United States

Site Status

The Cancer Center at Hackensack University Medical Center

Hackensack, New Jersey, United States

Site Status

Duke University Hospital

Durham, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Oregon Health Sciences University

Portland, Oregon, United States

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St. Luke's Hospital and Health Network

Bethlehem, Pennsylvania, United States

Site Status

Jones Cancer Center

Germantown, Tennessee, United States

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Vanderbilt University

Nashville, Tennessee, United States

Site Status

University of Texas/MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Swedish Cancer Institute

Seattle, Washington, United States

Site Status

Novartis Investigative Site

Darlinghurst, , Australia

Site Status

Novartis Investigative Site

Herston, , Australia

Site Status

Novartis Investigative Site

Liverpool, , Australia

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Novartis Investigative Site

Perth, , Australia

Site Status

Novartis Investigative Site

Prahran, , Australia

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Novartis Investigative Site

South Brisbane, , Australia

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Novartis Investigative Site

St Leonards, , Australia

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Novartis Investigative Site

Bruges, , Belgium

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Novartis Investigative Site

Ghent, , Belgium

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Novartis Investigative Site

Leuven, , Belgium

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Novartis Investigative Site

Mannheim, , Brazil

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Novartis Investigative Site

Porto Alegre, , Brazil

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Novartis Investigative Site

São Paulo, , Brazil

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Novartis Investigative Site

Olomouc, , Czechia

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Novartis Investigative Site

Prague, , Czechia

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Novartis Investigative Site

Berlin, , Germany

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Novartis Investigative Site

Düsseldorf, , Germany

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Novartis Investigative Site

Eisensach, , Germany

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Novartis Investigative Site

Firenze, , Germany

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Novartis Investigative Site

Greifswald, , Germany

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Novartis Investigative Site

Hamburg, , Germany

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Novartis Investigative Site

Jena, , Germany

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Novartis Investigative Site

Kiel, , Germany

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Novartis Investigative Site

Leipzeg, , Germany

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Novartis Investigative Site

Postsdam, , Germany

Site Status

Novartis Investigative Site

Rostock, , Germany

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Novartis Investigative Site

Stuttgart, , Germany

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Novartis Investigative Site

Weiden, , Germany

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Novartis Investigative Site

Bologna, , Italy

Site Status

Novartis Investigative Site

Milan, , Italy

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Novartis Investigative Site

Napoli, , Italy

Site Status

Novartis Investigative Site

Orbassano, , Italy

Site Status

Novartis Investigative Site

Reggio Calabra, , Italy

Site Status

Novartis Investigative Site

Roma, , Italy

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Novartis Investigative Site

Nagoya, , Japan

Site Status

Novartis Investigative Site

Oaska, , Japan

Site Status

Novartis Investigative Site

Tokyo, , Japan

Site Status

Novartis Investigative Site

Hwasun-Gun, , South Korea

Site Status

Novartis Investigative Site

Seoul, , South Korea

Site Status

Novartis Investigative Site

Barcelona, , Spain

Site Status

Novartis Investigative Site

Madrid, , Spain

Site Status

Novartis Investigative Site

Salamanca, , Spain

Site Status

Novartis Investigative Site

Santiago de Compostela, , Spain

Site Status

Novartis Investigative Site

Valencia, , Spain

Site Status

Countries

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United States Australia Belgium Brazil Czechia Germany Italy Japan South Korea Spain

References

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Agrawal M, Hanfstein B, Erben P, Wolf D, Ernst T, Fabarius A, Saussele S, Purkayastha D, Woodman RC, Hofmann WK, Hehlmann R, Hochhaus A, Muller MC. MDR1 expression predicts outcome of Ph+ chronic phase CML patients on second-line nilotinib therapy after imatinib failure. Leukemia. 2014 Jul;28(7):1478-85. doi: 10.1038/leu.2014.6. Epub 2014 Jan 10.

Reference Type DERIVED
PMID: 24472814 (View on PubMed)

Other Identifiers

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CAMN107A2302

Identifier Type: -

Identifier Source: org_study_id