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CMR Rate of Newly Diagnosed CML-CP Patients Treated With Nilotinib

NCT ID: NCT01227577

Last Updated: 2016-02-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2014-11-30

Brief Summary

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"This is a single-arm, open-label, multi-center study of complete molecular response (CMR) in adult patients with newly diagnosed Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia in chronic phase (CML-CP). The study is designed to evaluate early and deep molecular responses up to 4 years on nilotinib treatment. The primary end point is Rate of confirmed CMR in newly diagnosed Philadelphia chromosome positive CML-CP patients."

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Nilotinib in Newly Diagnosed Adult Philadelphia Chromosome & /or BCR-ABL Positive Chronic Myeloid Leukaemia in Chronic Phase

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Detailed Description

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Conditions

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Chronic Myelogenous Leukemia in Chronic Phase

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nilotinib

Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.

Group Type EXPERIMENTAL

Nilotinib

Intervention Type DRUG

Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.

Interventions

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Nilotinib

Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Patients with Ph+ CML-CP within 3 months of diagnosis. Male or female patients' ≥ 18 years of age. Patients must have adequate end organ function.

Exclusion Criteria

Impaired cardiac function as defined by the protocol. Patients with contraindications to receiving nilotinib, including concomitant medications.
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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Pacific Cancer Medical Center, Inc.

Anaheim, California, United States

Site Status

Providence St. Joseph Medical Center Roy&Patricia Disney Fam Cancer

Burbank, California, United States

Site Status

Bay Area Cancer Research Dept.ofBayAreaCancerResearch

Concord, California, United States

Site Status

St. Jude Heritage Medical Group Virginia Crosson Cancer Center

Yorba Linda, California, United States

Site Status

Sarah Cannon Research Institute SCRI

Jacksonville, Florida, United States

Site Status

Advanced Medical Specialties

Miami, Florida, United States

Site Status

Pasco Hernando Oncology

New Port Richey, Florida, United States

Site Status

Georgia Regents University MedCollege of GA Cancer Ctr 2

Augusta, Georgia, United States

Site Status

Stroger Cook County Hospital Division of Hematology & Onc

Chicago, Illinois, United States

Site Status

Louis A. Weiss Memorial Hospital

Chicago, Illinois, United States

Site Status

Indiana Blood and Marrow Institute

Beach Grove, Indiana, United States

Site Status

Cancer Center of Kansas

Witchita, Kansas, United States

Site Status

LSU HEALTH SCIENCES CENTER/ LSU SCHOOL OF MEDICINE Feist-Weiller Cancer Center(3)

New Orleans, Louisiana, United States

Site Status

University of Maryland

Baltimore, Maryland, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Henry Ford Hospital

Detroit, Michigan, United States

Site Status

St. Louis University Cancer Center

St Louis, Missouri, United States

Site Status

University of Nebraska Medical Center University of Nebraska Med Ctr

Omaha, Nebraska, United States

Site Status

Hackensack University Medical Center Dept.of HackensackUniv.MedCtr.

Hackensack, New Jersey, United States

Site Status

University of Rochester Medical Ct James P Wilmot Cancer Ctr

Rochester, New York, United States

Site Status

Montefiore Medical Center

The Bronx, New York, United States

Site Status

Duke University Medical Center Duke University Med Ctr

Durham, North Carolina, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Cancer Centers of the Carolinas Cancer Center

Greenville, South Carolina, United States

Site Status

Chattanooga Oncology and Hematology Assoicates, PC Chattanooga Oncology

Chattanooga, Tennessee, United States

Site Status

The Jones Clinic

Germantown, Tennessee, United States

Site Status

Tennessee Oncology Sarah Cannon Research Inst.

Nashville, Tennessee, United States

Site Status

Baylor Research Institute Baylor Research Institute (17)

Dallas, Texas, United States

Site Status

Oncology Consultants Oncology Consultants, P.A.

Houston, Texas, United States

Site Status

Millennium Oncology

Houston, Texas, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Providence Regional Cancer Partnership

Everett, Washington, United States

Site Status

Countries

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United States

References

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Berdeja JG, Heinrich MC, Dakhil SR, Goldberg SL, Wadleigh M, Kuriakose P, Cortes J, Radich J, Helton B, Rizzieri D, Paley C, Dautaj I, Mauro MJ. Rates of deep molecular response by digital and conventional PCR with frontline nilotinib in newly diagnosed chronic myeloid leukemia: a landmark analysis. Leuk Lymphoma. 2019 Oct;60(10):2384-2393. doi: 10.1080/10428194.2019.1590569. Epub 2019 Mar 26.

Reference Type DERIVED
PMID: 30912699 (View on PubMed)

Other Identifiers

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CAMN107AUS28

Identifier Type: -

Identifier Source: org_study_id

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