A Study of Imatinib Versus Nilotinib in Adult Patients With a Suboptimal Cytogenetic Response With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) - Full Text View

A Study of Imatinib Versus Nilotinib in Adult Patients With a Suboptimal Cytogenetic Response With Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia in Chronic Phase (CML-CP) (ENEST)

This study has been terminated.

First Received: August 17, 2007 Last Updated: December 23, 2009 History of Changes

Sponsor:	Novartis Pharmaceuticals
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00519090

Purpose

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).

Condition	Intervention	Phase
Myelogenous Leukemia	Drug: nilotinib	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Bone Marrow Diseases Cancer Leukemia, Adult Acute Leukemia, Adult Chronic

Drug Information available for: Imatinib Imatinib mesylate

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

Rate of complete cytogenetic response (CCyR) after 12 months of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To evaluate the rate of durable complete cytogenetic response at 24 months [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment:	6
Study Start Date:	October 2007
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Nilotinib (AMN107): Experimental	Drug: nilotinib
Imatinib: Active Comparator	Drug: nilotinib

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

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).

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519090

Show 82 Study Locations

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Novartis Pharmaceuticals ( External Affairs )
Study ID Numbers:	CAMN107A2302
Study First Received:	August 17, 2007
Last Updated:	December 23, 2009
ClinicalTrials.gov Identifier:	NCT00519090 History of Changes
Health Authority:	United States: Food and Drug Administration; European Union: European Medicines Agency

Keywords provided by Novartis:

leukemia
bone marrow
leukemia symptoms
lukemia
cml
complete blood count
lymphocyte
blood cancer
leukocytes
chronic leukemia
bone marrow biopsy
leukemia research
leukemia cells
bone marrow disease

chronic myeloid leukemia
blood cancer symptoms
white blood cell diseases
chronic myelogenous leukemia
leukemia treatment
leukemia facts
leucemia
facts about leukemia
myelogenous leukemia
bone marrow
newly diagnosed CML
suboptimal response
Philadelphia chromosome positive (Ph+)
chronic myelogenous leukemia in chronic phase (CML-CP)

Additional relevant MeSH terms:

Philadelphia Chromosome
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Hematologic Diseases
Myeloproliferative Disorders
Enzyme Inhibitors
Leukemia, Myeloid
Protein Kinase Inhibitors
Pharmacologic Actions

Translocation, Genetic
Imatinib
Leukemia
Neoplasms
Pathologic Processes
Therapeutic Uses
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Chromosome Aberrations
Bone Marrow Diseases

ClinicalTrials.gov processed this record on February 08, 2010