NCT00519090|TerminatedPhase 3ResultsDMC

Study Stopped

This study was terminated due to limited enrollment.

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

ENEST

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

Novartis Pharmaceuticals ClinicalTrials.gov

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1 other identifier

CAMN107A2302

Study Type

interventional

Target

Locations

10 countries

Sites

Timeline

RegisteredAug 2007

StartedOct 2007

CompletionOct 2008

Brief Summary

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).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Oct 2007

Shorter than P25 for phase_3

Geographic Reach

10 countries

80 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1 year study duration

First Submitted

Initial submission to the registry

August 17, 2007

Completed

4 days until next milestone

First Posted

Study publicly available on registry

August 21, 2007

Completed

1 month until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed

2.6 years until next milestone

Results Posted

Study results publicly available

May 10, 2011

Completed

Last Updated

November 7, 2011

Status Verified

November 1, 2011

Enrollment Period

1 year

First QC Date

August 17, 2007

Results QC Date

November 11, 2010

Last Update Submit

November 4, 2011

Conditions

Myelogenous Leukemia

Keywords

leukemiabone marrowleukemia symptomscmlcomplete blood countlymphocyteblood cancerleukocyteschronic leukemiabone marrow biopsyleukemia researchleukemia cellsbone marrow diseasechronic myeloid leukemiablood cancer symptomswhite blood cell diseaseschronic myelogenous leukemialeukemia treatmentleukemia factsleucemiafacts about leukemiamyelogenous leukemianewly diagnosed CMLsuboptimal responsePhiladelphia chromosome positive (Ph+)chronic myelogenous leukemia in chronic phase (CML-CP)

Outcome Measures

Primary Outcomes (1)

Complete Cytogenetic Response Rate(CCyR) in Patients Who Had a Suboptimal Cytogenetic Response on Imatinib
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 Outcomes (1)

Durable Complete Cytogenetic Response Rate
24 months

Study Arms (2)

Nilotinib (AMN107)

EXPERIMENTAL

Drug: Nilotinib (AMN107)

Imatinib

ACTIVE COMPARATOR

Drug: Imatinib

Interventions

ImatinibDRUG

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.

Also known as: STI571, imatinib mesylate, Glivec®, Gleevec®

Imatinib

Nilotinib (AMN107)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.

Nilotinib (AMN107)

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Novartis Pharmaceuticalslead